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  • 1.
    Bartha, Erzsebet
    et al.
    Karolinska University Hospital, Sweden.
    Davidson, Thomas
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Brodtkorb, Thor-Henrik
    RTI Health Solut, Sweden.
    Carlsson, Per
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Kalman, Sigridur
    Karolinska University Hospital, Sweden.
    Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients2013In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 14Article in journal (Refereed)
    Abstract [en]

    Background

    A randomized, controlled trial, intended to include 460 patients, is currently studying peroperative goal-directed hemodynamic treatment (GDHT) of aged hip-fracture patients. Interim efficacy analysis performed on the first 100 patients was statistically uncertain; thus, the trial is continuing in accordance with the trial protocol. This raised the present investigation’s main question: Is it reasonable to continue to fund the trial to decrease uncertainty? To answer this question, a previously developed probabilistic cost-effectiveness model was used. That model depicts (1) a choice between routine fluid treatment and GDHT, given uncertainty of current evidence and (2) the monetary value of further data collection to decrease uncertainty. This monetary value, that is, the expected value of perfect information (EVPI), could be used to compare future research costs. Thus, the primary aim of the present investigation was to analyze EVPI of an ongoing trial with interim efficacy observed.

    Methods

    A previously developed probabilistic decision analytic cost-effectiveness model was employed to compare the routine fluid treatment to GDHT. Results from the interim analysis, published trials, the meta-analysis, and the registry data were used as model inputs. EVPI was predicted using (1) combined uncertainty of model inputs; (2) threshold value of society’s willingness to pay for one, quality-adjusted life-year; and (3) estimated number of future patients exposed to choice between GDHT and routine fluid treatment during the expected lifetime of GDHT.

    Results

    If a decision to use GDHT were based on cost-effectiveness, then the decision would have a substantial degree of uncertainty. Assuming a 5-year lifetime of GDHT in clinical practice, the number of patients who would be subject to future decisions was 30,400. EVPI per patient would be €204 at a €20,000 threshold value of society’s willingness to pay for one quality-adjusted life-year. Given a future population of 30,400 individuals, total EVPI would be €6.19 million.

    Conclusions

    If future trial costs are below EVPI, further data collection is potentially cost-effective. When applying a cost-effectiveness model, statements such as ‘further research is needed’ are replaced with ‘further research is cost-effective and ‘further funding of a trial is justified’.

  • 2.
    Beukes, Eldre W.
    et al.
    Anglia Ruskin University, England.
    Baguley, David M.
    Anglia Ruskin University, England; Nottingham Biomed Research Centre, England; University of Nottingham, England.
    Allen, Peter M.
    Anglia Ruskin University, England; Anglia Ruskin University, England.
    Manchaiah, Vinaya
    Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences. Linköping University, The Swedish Institute for Disability Research. Lamar University, TX 77710 USA; Audiol India, India; Manipal University, India.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Karolinska Institute, Sweden.
    Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, article id 186Article in journal (Refereed)
    Abstract [en]

    Background: Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. population. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. Methods/design: This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. Discussion: This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems.

  • 3.
    Björnsson, Bergthor
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Sandström, Per
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Lindhoff Larsson, Anna
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Hjalmarsson, Claes
    Blekinge Hosp, Sweden; Lund Univ, Sweden.
    Gasslander, Thomas
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Laparoscopic versus open distal pancreatectomy (LAPOP): study protocol for a single center, nonblinded, randomized controlled trial2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, article id 356Article in journal (Refereed)
    Abstract [en]

    BackgroundEarlier nonrandomized studies have suggested that laparoscopic distal pancreatectomy (LDP) is advantageous compared with open distal pancreatectomy (ODP) regarding hospital stay, blood loss, and recovery. Only one randomized study has been conducted showing reduced time to functional recovery after LDP compared with ODP.MethodsLAPOP is a prospective randomized, nonblinded, parallel-group, single-center superiority trial. Sixty patients with lesions in the pancreatic body or tail that are found by a multidisciplinary tumor board to need surgical resection will be randomized to receive LDP or ODP. The primary outcome variable is postoperative hospital stay, and secondary outcomes include functional recovery (defined as no need for intravenous medications or fluids and as the ability of an ambulatory patient to perform activities of daily life), perioperative bleeding, complications, need for pain medication, and quality of life comparison.DiscussionThe LAPOP trial will test the hypothesis that LDP reduces postoperative hospital stay compared with ODP.Trial registrationISRCTN, 26912858. Registered on 28 September 2015.

  • 4.
    Boettcher, Johanna
    et al.
    Department of Clinical Psychology and Psychotherapy, Freie Universität Berlin, Berlin, Germany.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Carlbring, Per
    Department of Psychology, Stockholm University, Sweden.
    Combining attention training with cognitive-behavior therapy in Internet-based self-help for social anxiety: study protocol for a randomized controlled trial2013In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 14, no 1, p. 68-Article in journal (Refereed)
    Abstract [en]

    Background

    Guided Internet-based cognitive-behavioral therapy (ICBT) has been found to be effective for social anxiety disorder (SAD) by several independent research groups. However, since the extent of clinically significant change demonstrated leaves room for improvement, new treatments should be developed and investigated. A novel treatment, which has generally been found to be effective, is cognitive bias modification (CBM). This study aims to evaluate the combination of CBM and ICBT. It is intended that two groups will be compared; one group randomized to receiving ICBT and CBM towards threat cues and one group receiving ICBT and control training. We hypothesize that the group receiving ICBT plus CBM will show superior treatment outcomes.

    Methods/design

    Participants with SAD (N = 128), will be recruited from the general population. A composite score combining the scores obtained from three social anxiety questionnaires will serve as the primary outcome measure. Secondary measures include self-reported depression and quality of life. All treatments and assessments will be conducted via the Internet and measurement points will be baseline, Week 2, post-treatment, and 4 months post-treatment.

    Discussion

    There is no direct evidence of the effects of combining CBM and ICBT in SAD. Adding attention-training sessions to ICBT protocols could increase the proportion of participants who improve and recover through Internet-based self-help.

    Trial registration

    ClinicalTrials.gov:NCT01570400

  • 5.
    Carlbring, Per
    et al.
    Department of Psychology, Stockholm University, Stockholm, Sweden.
    Lindner, Philip
    Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden and Department of Psychology, Umeå University, Umeå, Sweden .
    Martell, Christopher
    Martell Behavioral Activation Research Consulting and Department of Psychology, University of Wisconsin, Milwaukee, WI, USA.
    Hassmén, Peter
    Department of Psychology, Umeå University, Umeå, Sweden.
    Forsberg, Lars
    Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
    Ström, Lars
    Department of Psychology, Umeå University, Umeå, Sweden.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial2013In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 14, no 35Article in journal (Refereed)
    Abstract [en]

    Background

    Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components.

    Methods/Design

    This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1) physical exercise without a clear treatment rationale; (2) physical exercise with treatment rationale; (3) behavioural activation with treatment rationale; or (4) behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period.

    Discussion

    The results of this study will constitute an important contribution to the body of knowledge of the respective interventions. Limitations are discussed.

    Trial registration

    ClinicalTrials.gov: NCT01619930

  • 6.
    Gonzalez, Manuel
    et al.
    Umea Univ, Sweden; Umea Univ, Sweden; Commonwealth Sci Res and Ind Org CSIRO, Australia.
    Sjolin, Ingela
    Lund Univ, Sweden; Skane Univ Hosp, Sweden.
    Bäck, Maria
    Linköping University, Department of Medical and Health Sciences, Division of Physiotherapy. Linköping University, Faculty of Medicine and Health Sciences. Sahlgrens Univ Hosp, Sweden.
    Michelsen, Halldora Ogmundsdottir
    Lund Univ, Sweden; Skane Univ Hosp, Sweden.
    Tanha, Tina
    Lund Univ, Sweden; Skane Univ Hosp, Sweden.
    Sandberg, Camilla
    Umea Univ, Sweden; Umea Univ, Sweden; Umea Univ, Sweden.
    Schiopu, Alexandru
    Lund Univ, Sweden; Skane Univ Hosp, Sweden.
    Leosdottir, Margret
    Lund Univ, Sweden; Skane Univ Hosp, Sweden.
    Effect of a lifestyle-focused electronic patient support application for improving risk factor management, self-rated health, and prognosis in post-myocardial infarction patients: study protocol for a multi-center randomized controlled trial2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, article id 76Article in journal (Refereed)
    Abstract [en]

    BackgroundCardiac rehabilitation (CR) programs addressing risk factor management, educational interventions, and exercise contribute to reduce mortality after myocardial infarction (MI). However, the fulfillment of guideline-recommended CR targets is currently unsatisfactory. eHealth, i.e., the use of electronic communication for healthcare, including the use of mobile smartphone applications combined with different sensors and interactive computerized programs, offers a new array of possibilities to provide clinical care. The present study aims to assess the efficacy of a web-based application (app) designed to support persons in adhering to lifestyle advice and medication as a complement to traditional CR programs for improvement of risk factors and clinical outcomes in patients with MI compared with usual care.Methods/designAn open-label multi-center randomized controlled trial is being conducted at different CR centers from three Swedish University Hospitals. The aim is to include 150 patients with MI amp;lt;75years of age who are confident smartphone and/or Internet users. In addition to participation in CR programs according to the usual routine at each center, patients randomized to the intervention arm will receive access to the web-based app. A CR nurse reviews the patients self-reported data twice weekly through a medical interface at the clinic. The primary outcome of the study will be change in submaximal exercise capacity (in watts) between 2 and 4weeks after discharge and when the patient has completed his/her exercise program at the CR center, usually around 3-6months post-discharge. Secondary outcomes include changes in self-reported physical activity, objectively assessed physical activity by accelerometry, self-rated health, dietary, and smoking habits, body mass index, blood pressure, blood lipids, and glucose/HbA1c levels between inclusion and follow-up visits during the first year post-MI. Additionally, we will assess uptake and adherence to the application, the number of CR staff contacts, and the incidence of cardiovascular events at 1 and 3 years after the MI. Patient recruitment started in 2016, and the first study results are expected in the beginning of 2019.DiscussionThe present study will add evidence to whether electronic communication can be used to improve traditional CR programs for patients after MI.Trial registrationClinicalTrials.gov, NCT03260582. Retrospectively registered on 24 August 2017.

  • 7.
    Harding, Andrew J. E.
    et al.
    Univ Lancaster, England.
    Morbey, Hazel
    Univ Lancaster, England.
    Ahmed, Faraz
    Univ Lancaster, England.
    Opdebeeck, Carol
    Manchester Metropolitan Univ, England.
    Wang, Ying-Ying
    Univ Lancaster, England.
    Williamson, Paula
    Univ Liverpool, England.
    Swarbrick, Caroline
    Univ Manchester, England.
    Leroi, Iracema
    Univ Manchester, England.
    Challis, David
    Univ Manchester, England.
    Davies, Linda
    Univ Manchester, England.
    Reeves, David
    Univ Manchester, England.
    Holland, Fiona
    Univ Manchester, England.
    Hann, Mark
    Univ Manchester, England.
    Hellström, Ingrid
    Linköping University, Department of Social and Welfare Studies, Division of Nursing Science. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Local Health Care Services in East Östergötland.
    Hydén, Lars-Christer
    Linköping University, Department of Social and Welfare Studies, Division Ageing and Social Change. Linköping University, Faculty of Arts and Sciences.
    Burns, Alistair
    Univ Manchester, England.
    Keady, John
    Univ Manchester, England; Greater Manchester Mental Hlth NHS Fdn Trust, England.
    Reilly, Siobhan
    Univ Lancaster, England.
    Developing a core outcome set for people living with dementia at home in their neighbourhoods and communities: study protocol for use in the evaluation of non-pharmacological community-based health and social care interventions2018In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, article id 247Article in journal (Refereed)
    Abstract [en]

    Background: The key aim of the study is to establish an agreed standardised core outcome set (COS) for use when evaluating non-pharmacological health and social care interventions for people living at home with dementia. Methods/design: Drawing on the guidance and approaches of the Core Outcome Measures in Effectiveness Trials (COMET), this study uses a four-phase mixed-methods design: 1 Focus groups and interviews with key stakeholder groups (people living with dementia, care partners, relevant health and social care professionals, researchers and policymakers) and a review of the literature will be undertaken to build a long list of outcomes. 2 Two rounds of Delphi surveys will be used with key stakeholder groups. Statements for the Delphi surveys and participation processes will be developed and informed through substantial member involvement with people living with dementia and care partners. A consensus meeting will be convened with key participant groups to discuss the key findings and finalise the COS. 3 A systematic literature review will be undertaken to assess the properties of tools and instruments to assess components of the COS. Measurement properties, validity and reliability will be assessed using the Consensus-based Standards for the Selection of Health Measurement (COSMIN) and COMET guidance. 4 A stated preference survey will elicit the preferences of key stakeholders for the outcomes identified as important to measure in the COS. Discussion: To the best of our knowledge, this study is the first to use a modified Delphi process to involve people living with dementia as a participant group. Though the study is confined to collecting data in the United Kingdom, use of the COS by researchers will enhance the comparability of studies evaluating non-pharmacological and community-based interventions.

  • 8.
    Karlsson, Jan Olof
    et al.
    Linköping University, Department of Medical and Health Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Jynge, Per
    Linköping University, Department of Medical and Health Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Lundström, Ingemar
    Linköping University, Department of Physics, Chemistry and Biology, Sensor and Actuator Systems. Linköping University, Faculty of Science & Engineering.
    Ignarro, Louis J.
    Linköping University, Department of Medical and Health Sciences, Division of Drug Research. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Diagnostics, Department of Clinical Pharmacology.
    Letter in response to: "Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N acetylcysteine for paracetamol overdosethe PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomised controlled trial"2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, article id 380Article in journal (Other academic)
    Abstract [en]

    n/a

  • 9.
    Kleiboer, A
    et al.
    Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    Smit, J
    Department of Psychiatry, VU University Medical Centre and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    Bosmans, J
    Department of Health Sciences, Vrije Universiteit Amsterdam and EMGO+ Institute for Health and Care Research, Amsterdam, The Netherlands.
    Ruwaard, J
    Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Department of Clinical Neuroscience, Psychiatry Section, Karolinska Institutet.
    Topooco, Naira
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Linköping University, The Swedish Institute for Disability Research.
    Berger, T
    Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.
    Krieger, T
    Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.
    Botella, C
    Department of Psychology and Technology, Jaume University, Castellon, Spain.; Department of Personalidad, Evaluación y Tratamiento Psicológicos, Valencia, Spain.
    Baños, R
    Department of Personalidad, Evaluación y Tratamiento Psicológicos, Valencia, Spain.
    Chevreul, K
    URC-ECO, Ile-de-France (AP-HP), Paris, France.
    Araya, R
    Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.
    Cerga-Pashoja, A
    Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.
    Cieślak, R
    Department of Psychology, Szkoła Wyzsza Psychologii Społeczne, University of Social Sciences and Humanities, Warsaw, Poland.
    Rogala, A
    Department of Psychology, Szkoła Wyzsza Psychologii Społeczne, University of Social Sciences and Humanities, Warsaw, Poland.
    Vis, C
    Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands.
    Draisma, S
    Department of Psychiatry, VU University Medical Centre and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    van Schaik, A
    Department of Psychiatry, VU University Medical Centre and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    Kemmeren, L
    Department of Psychiatry, VU University Medical Centre and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    Ebert, D
    Department of Clinical Psychology, Philipps University, Marburg, Germany.
    Berking, M
    Department of Clinical Psychology, Philipps University, Marburg, Germany.
    Funk, B
    Institut für elektronische Geschäftsprozesse, Leuphana University Lüneburg, Lüneburg, Germany.
    Cuijpers, P
    Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands.
    Riper, H
    Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands.; Department of Psychiatry, VU University Medical Centre and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries2016In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 17, no 1Article in journal (Refereed)
    Abstract [en]

    Background: Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care.

    Methods/design: E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country).

    Discussion: The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment.

    Trial Registration: France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660 . Registered on 18 February 2015; Spain: ClinicalTrials.gov NCT02361684 . Registered on 8 January 2015; Sweden: ClinicalTrials.gov NCT02449447 . Registered on 30 March 2015; Switzerland: ClinicalTrials.gov NCT02410616 . Registered on 2 April 2015; United Kingdom: ISRCTN registry, ISRCTN12388725 . Registered on 20 March 2015.

  • 10.
    Kues, Johanna N.
    et al.
    University of Marburg, Germany.
    Janda, Carolyn
    University of Marburg, Germany.
    Kleinstaeuber, Maria
    University of Marburg, Germany.
    Weise, Cornelia
    Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences. Linköping University, The Swedish Institute for Disability Research.
    Internet-based cognitive behavioural self-help for premenstrual syndrome: study protocol for a randomised controlled trial2014In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 15, no 472Article in journal (Refereed)
    Abstract [en]

    Background: With a prevalence of 3 to 8% among women of reproductive age, severe premenstrual symptoms are very common. Symptoms range from emotional and cognitive to physical changes. Severe symptoms (that is, premenstrual syndrome) can have a strong impact on everyday functioning and quality of life. Impairment can be as serious as that of dysthymic disorders. Many affected women receive either no treatment at all or are unsatisfied with their treatment. Although there is some evidence for the reduction of distress through cognitive behavioural therapy, there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach. Thus, this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome. Methods/design: The study is conducted as a randomised controlled trial. The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview. Eligible women are randomly assigned to either a treatment or a wait-list control group. The intervention is based on cognitive behavioural therapy principles and is provided via the internet. It consists of 14 different modules on which participants work over 8 consecutive weeks. In addition to written information, participants receive email feedback from a clinical psychologist on a weekly basis. Participants assigned to the wait-list receive the treatment after the end of the waiting period (8 weeks). The primary outcome measure is the Premenstrual Syndrome Impairment Measure. Secondary outcomes include the Premenstrual Syndrome Coping Measure, the Short-Form Social Support Questionnaire, the Questionnaire for the Assessment of Relationship Quality, and the Perceived Stress Scale. Data is collected during the premenstrual (luteal) phase at pre-treatment, post-treatment, and 6-month follow-up. Discussion: So far, there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome. The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options.

  • 11.
    Lindner, Philip
    et al.
    Karolinska Institute, Sweden .
    Ivanova, Ekaterina
    Stockholm University, Sweden .
    Hoa Ly, Kien
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Carlbring, Per
    Stockholm University, Sweden .
    Guided and unguided CBT for social anxiety disorder and/or panic disorder via the Internet and a smartphone application: study protocol for a randomised controlled trial2013In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 14, no 437Article in journal (Refereed)
    Abstract [en]

    Background: Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effects of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a smartphone application. The effect of added therapist support will also be studied. Methods/Design: One hundred and fifty participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to either one of three study groups: 1, smartphone-supplemented iCBT with therapist support; 2, smartphone-supplemented iCBT without therapist support; or 3, an active waiting list control group with delayed treatment. Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale. Secondary measures include other anxiety, depression and quality of life measures. In addition to pre- and post-treatment measurements, the study includes two mid-treatment (days 24 and 48) and two follow-up assessments (12 and 36 months) to assess rapid and long-term effects. Discussion: To our knowledge, this is the first study to investigate the effectiveness of smartphone-supplemented iCBT for anxiety disorders. Hence, the findings from this trial will constitute great advancements in the burgeoning and promising field of smartphone-administered psychological interventions. Limitations are discussed.

  • 12.
    Ljunggren, Stefan
    et al.
    Södertalje Hospital, Sweden Karolinska Institute, Sweden.
    Hahn, Robert G
    Linköping University, Department of Medical and Health Sciences, Anesthesiology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Sinnescentrum, Department of Anaesthesiology and Surgery UHL.
    Oral nutrition or water loading before hip replacement surgery; a randomized clinical trial2012In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 13, no 97Article in journal (Refereed)
    Abstract [en]

    Background

    Surgery induces insulin resistance that might be alleviated by a nutritional drink given preoperatively. The authors hypothesized that some of the beneficial effects of the drink could be attributed to the volume component (approximately 1 L) rather than to the nutrients.

    Methods

    Sixty patients scheduled for elective total hip replacement under spinal anesthesia were recruited to a clinical trial, and randomly allocated to preoperative fasting, to oral ingestion of tap water, or to oral ingestion of a carbohydrate drink. An intravenous glucose tolerance test calculated glucose clearance and insulin sensitivity on the day before surgery, in the postoperative ward, and on the day after surgery. Other parameters were stress (cortisol in plasma and urine), muscle catabolism (urinary 3-methylhistidine), and wellbeing.

    Results

    Fifty-seven patients completed the study. In the postoperative ward, the glucose clearance and the insulin response had decreased from the previous day by 23% and 36%, respectively. Insulin sensitivity did not decrease until the next morning (−48%) and was due to an increased insulin response (+51%). Cortisol excretion was highest on the day of surgery, while 3-methylhistidine increased 1 day later. Follow-up on the third postoperative day showed an average of 1.5 complications per patient. Wellbeing was better 2 weeks after than before the surgery. None of the measured parameters differed significantly between the study groups.

    Conclusions

    Preoperative ingestion of tap water or a nutritional drink had no statistically significant effect on glucose clearance, insulin sensitivity, postoperative complications, or wellbeing in patients undergoing elective hip surgery.

  • 13.
    Manchaiah, Vinaya K. C.
    et al.
    Linköping University, The Swedish Institute for Disability Research. Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences.
    Stephens, Dafydd
    Cardiff University, UK.
    Andersson, Gerhard
    Linköping University, The Swedish Institute for Disability Research. Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences.
    Rönnberg, Jerker
    Linköping University, The Swedish Institute for Disability Research. Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences.
    Lunner, Thomas
    Linköping University, The Swedish Institute for Disability Research. Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences.
    Use of the ‘patient journey’ model in the internet-based pre-fitting counseling of a person with hearing disability: study protocol for a randomized controlled trial2013In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 14, no 25Article in journal (Refereed)
    Abstract [en]

    Background

    Hearing impairment is one of the most frequent chronic conditions. Persons with a hearing impairment (PHI) have various experiences during their ‘journey’ through hearing loss. In our previous studies we have developed a ‘patient journey’ model of PHI and their communication partners (CPs). We suggest this model could be useful in internet-based pre-fitting counseling of a person with hearing disability (PHD).

    Methods/Design

    A randomized controlled trial (RCT) with waiting list control (WLC) design will be used in this study. One hundred and fifty eight participants with self-reported hearing disability (that is, score >20 in the Hearing Handicap Questionnaire (HHQ)) will be recruited to participate in this study. They will be assigned to one of two groups (79 participants in each group): (1) Information and counseling provision using the ‘patient journey’ model; and (2) WLC. They will participate in a 30 day (4 weeks) internet-based counseling program based on the ‘patient journey’ model. Various outcome measures which focuses on hearing disability, depression and anxiety, readiness to change and acceptance of hearing disability will be administered pre (one week before) and post (one week and six months after) intervention to evaluate the effectiveness of counseling.

    Discussion

    Internet-based counseling is being introduced as a viable option for audiological rehabilitation. We predict that the ‘patient journey’ model will have several advantages during counseling of a PHD. Such a program, if proven effective, could yield cost and time-efficient ways of managing hearing disability.

  • 14.
    Miloff, Alexander
    et al.
    Stockholm University, Sweden.
    Lindner, Philip
    Stockholm University, Sweden; Karolinska Institute, Sweden.
    Hamilton, William
    Stockholm University, Sweden; Mimerse, Sweden.
    Reuterskiold, Lena
    Stockholm University, Sweden.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Karolinska Institute, Sweden.
    Carlbring, Per
    Stockholm University, Sweden.
    Single-session gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial2016In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 17, no 60Article in journal (Refereed)
    Abstract [en]

    Background: Traditional one-session exposure therapy (OST) in which a patient is gradually exposed to feared stimuli for up to 3 h in a one-session format has been found effective for the treatment of specific phobias. However, many individuals with specific phobia are reluctant to seek help, and access to care is lacking due to logistic challenges of accessing, collecting, storing, and/or maintaining stimuli. Virtual reality (VR) exposure therapy may improve upon existing techniques by facilitating access, decreasing cost, and increasing acceptability and effectiveness. The aim of this study is to compare traditional OST with in vivo spiders and a human therapist with a newly developed single-session gamified VR exposure therapy application with modern VR hardware, virtual spiders, and a virtual therapist. Methods/design: Participants with specific phobia to spiders (N = 100) will be recruited from the general public, screened, and randomized to either VR exposure therapy (n = 50) or traditional OST (n = 50). A behavioral approach test using in vivo spiders will serve as the primary outcome measure. Secondary outcome measures will include spider phobia questionnaires and self-reported anxiety, depression, and quality of life. Outcomes will be assessed using a non-inferiority design at baseline and at 1, 12, and 52 weeks after treatment. Discussion: VR exposure therapy has previously been evaluated as a treatment for specific phobias, but there has been a lack of high-quality randomized controlled trials. A new generation of modern, consumer-ready VR devices is being released that are advancing existing technology and have the potential to improve clinical availability and treatment effectiveness. The VR medium is also particularly suitable for taking advantage of recent phobia treatment research emphasizing engagement and new learning, as opposed to physiological habituation. This study compares a market-ready, gamified VR spider phobia exposure application, delivered using consumer VR hardware, with the current gold standard treatment. Implications are discussed.

  • 15.
    Mourad, Ghassan
    et al.
    Linköping University, Department of Social and Welfare Studies, Division of Nursing Science. Linköping University, Faculty of Medicine and Health Sciences.
    Strömberg, Anna
    Linköping University, Department of Medical and Health Sciences, Division of Nursing Science. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Cardiology in Linköping.
    Jonsbu, Egil
    More and Romsdal Hospital Trust, Norway; Norwegian University of Science and Technology, Norway.
    Gustafsson, Mikael
    Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Cardiology in Linköping. Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine.
    Johansson, Peter
    Linköping University, Department of Social and Welfare Studies, Division of Nursing Science. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Cardiology in Linköping.
    Jaarsma, Tiny
    Linköping University, Department of Social and Welfare Studies, Division of Nursing Science. Linköping University, Faculty of Medicine and Health Sciences.
    Guided Internet-delivered cognitive behavioural therapy in patients with non-cardiac chest pain - a pilot randomized controlled study2016In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 17, p. 1-12, article id 352Article in journal (Refereed)
    Abstract [en]

    Background: Patients with recurrent episodes of non-cardiac chest pain may experience cardiac anxiety and avoidance behavior, leading to increased healthcare utilization. These patients might benefit from help and support to evaluate the perception and management of their chest pain. The purpose of this study was to test the feasibility of a short guided Internet-delivered cognitive behavioural therapy (CBT) program and explore the effects on cardiac anxiety, fear of body sensations, depressive symptoms, and chest pain in patients with non-cardiac chest pain, compared with usual care. Methods: A pilot randomized controlled study was conducted. Fifteen patients with non-cardiac chest pain with cardiac anxiety or fear of body sensations, aged 22-76 years, were randomized to intervention (n = 7) or control (n = 8) groups. The four-session CBT program contained psychoeducation, physical activity, and relaxation. The control group received usual care. Data were collected before and after intervention. Results: Five of seven patients in the intervention group completed the program, which was perceived as user-friendly with comprehensible language, adequate and varied content, and manageable homework assignments. Being guided and supported, patients were empowered and motivated to be active and complete the program. Patients in both intervention and control groups improved with regard to cardiac anxiety, fear of body sensations, and depressive symptoms, but no significant differences were found between the groups. Conclusions: The Internet-delivered CBT program seems feasible for patients with non-cardiac chest pain, but needs to be evaluated in larger groups and with a longer follow-up period.

  • 16.
    Müssener, Ulrika
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Health Sciences.
    Bendtsen, Marcus
    Linköping University, Department of Computer and Information Science, Database and information techniques. Linköping University, The Institute of Technology.
    Karlsson, Nadine
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Health Sciences.
    White, Ian R.
    Cambridge Institute of Public Health.
    McCambridge, Jim
    University of York.
    Bendtsen, Preben
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Local Health Care Services in West Östergötland, Department of Medical Specialist in Motala.
    SMS-based smoking cessation intervention among university students: study protocol for a randomised controlled trial (NEXit trial)2015In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 16, article id 140Article in journal (Refereed)
    Abstract [en]

    Background: Most smoking efforts targeting young people have so far been focused on prevention of initiation, whereas smoking cessation interventions have largely been targeted towards adult populations. Thus, there is limited evidence for effective smoking cessation interventions in young people, even though many young people want to quit smoking. Mobile communication technology has the potential to reach large numbers of young people and recent text-based smoking cessation interventions using phones have shown promising results. Methods/design: The study aims to evaluate a newly developed text-based smoking cessation intervention for students in colleges and universities in Sweden. The design is a randomised controlled trial (RCT) with a delayed/waiting list intervention control condition. The trial will be performed simultaneously in all colleges and universities served by 25 student health care centres in Sweden. Outcomes will be evaluated after 4 months, with 2 cessation primary outcomes and 4 secondary outcomes. After outcome evaluation the control group will be given access to the intervention. Discussion: The study will examine the effectiveness of a stand-alone SMS text-based intervention. The intervention starts with a motivational phase in which the participants are given an opportunity to set a quit date within 4 weeks of randomisation. This first phase and the subsequent core intervention phase of 12 weeks are totally automated in order to easily integrate the intervention into the daily routines of student and other health care settings. As well as providing data for the effectiveness of the intervention, the study will also provide data for methodological analyses addressing a number issues commonly challenging in Internet-based RCTs. For example, an extensive follow-up strategy will be used in order to evaluate the use of repeated attempts in the analysis, and in particular to explore the validity of a possible missing not at random assumption that the odds ratio between the primary outcome and response is the same at every attempt.

  • 17.
    Olofsson Bagge, Roger
    et al.
    University of Gothenburg, Sweden.
    Ny, Lars
    University of Gothenburg, Sweden.
    All-Ericsson, Charlotta
    Karolinska Institute, Sweden.
    Sternby Eilard, Malin
    University of Gothenburg, Sweden.
    Rizell, Magnus
    University of Gothenburg, Sweden.
    Cahlin, Christian
    University of Gothenburg, Sweden.
    Stierner, Ulrika
    University of Gothenburg, Sweden.
    Lönn, Ulf
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Hansson, Johan
    Karolinska University Hospital, Sweden.
    Ljuslinder, Ingrid
    Norrlands University Hospital, Sweden.
    Lundgren, Lotta
    Skåne University Hospital, Sweden.
    Ullenhag, Gustav
    Uppsala University, Sweden.
    Folke Kiilgaard, Jens
    University of Copenhagen, Denmark.
    Nilsson, Jonas
    University of Gothenburg, Sweden.
    Lindner, Per
    University of Gothenburg, Sweden.
    Correction: Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial): study protocol for a randomized controlled trial (vol 15, 317, 2014)2015In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 16, no 334Article in journal (Other academic)
    Abstract [en]

    n/a

  • 18.
    Olofsson, Roger
    et al.
    University of Gothenburg, Sweden .
    Ny, Lars
    University of Gothenburg, Sweden .
    Sternby Eilard, Malin
    University of Gothenburg, Sweden .
    Rizell, Magnus
    University of Gothenburg, Sweden .
    Cahlin, Christian
    University of Gothenburg, Sweden .
    Stierner, Ulrika
    University of Gothenburg, Sweden .
    Lönn, Ulf
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Oncology.
    Hansson, Johan
    Karolinska University Hospital, Sweden .
    Ljuslinder, Ingrid
    Norrlands University Hospital, Sweden .
    Lundgren, Lotta
    Skåne University Hospital, Sweden .
    Ullenhag, Gustav
    Uppsala University, Sweden .
    Folke Kiilgaard, Jens
    University of Copenhagen, Denmark .
    Nilsson, Jonas
    University of Gothenburg, Sweden .
    Lindner, Per
    University of Gothenburg, Sweden .
    Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial): study protocol for a randomized controlled trial2014In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 15, no 317Article in journal (Refereed)
    Abstract [en]

    Background: Uveal melanoma is the most common primary intraocular malignancy in adults. Despite successful control of the primary tumor, metastatic disease will ultimately develop in approximately 50% of patients, with the liver being the most common site for metastases. The median survival for patients with liver metastases is between 6 and 12 months, and no treatment has in randomized trials ever been shown to prolong survival. A previous phase II trial using isolated hepatic perfusion (IHP) has suggested a 14-month increase in overall survival compared with a historic control group consisting of the longest surviving patients in Sweden during the same time period (26 versus 12 months). Methods/Design: This is the protocol for a multicenter phase III trial randomizing patients with isolated liver metastases of uveal melanoma to IHP or best alternative care (BAC). Inclusion criteria include liver metastases (verified by biopsy) and no evidence of extra-hepatic tumor manifestations by positron emission tomography-computed tomography (PET-CT). The primary endpoint is overall survival at 24 months, with secondary endpoints including response rate, progression-free survival, and quality of life. The planned sample size is 78 patients throughout five years. Discussion: Patients with isolated liver metastases of uveal melanoma origin have a short expected survival and no standard treatment option exists. This is the first randomized clinical trial to evaluate IHP as a treatment option with overall survival being the primary endpoint.

  • 19.
    Smoktunowicz, Ewelina
    et al.
    SWPS Univ Social Sci and Humanities, Poland.
    Lesnierowska, Magdalena
    SWPS Univ Social Sci and Humanities, Poland.
    Cieslak, Roman
    SWPS Univ Social Sci and Humanities, Poland; Univ Colorado, CO 80907 USA.
    Carlbring, Per
    Stockholm Univ, Sweden; Univ Southern Denmark, Denmark.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Otorhinolaryngology. Karolinska Inst, Sweden.
    Efficacy of an Internet-based intervention for job stress and burnout among medical professionals: study protocol for a randomized controlled trial2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, article id 338Article in journal (Refereed)
    Abstract [en]

    BackgroundMedical professionals are at high risk of job stress and burnout. Research shows that work-related stress can be reduced through enhancing psychological resources, in particular, self-efficacy and perceived social support. These psychological resources can operate either individually or sequentially: in line with the cultivation hypothesis, self-efficacy precedes and cultivates perceived social support, whereas according to the enabling hypothesis it is perceived social support that comes first and enables self-efficacy. Based on this theoretical framework we developed an internet-based intervention, Med-Stress, dedicated to healthcare providers and aimed at reducing job stress and burnout. Med-Stress contains two modules that enhance self-efficacy and perceived social support, which are tested in four variants reflected in four study conditions. We expect that sequential enhancement of resources: self-efficacy and social support or social support and self-efficacy will yield larger posttest results than individual enhancement.MethodsIn this four-arm randomized controlled trial we will test four variants of the Med-Stress intervention. The trial is open for professionally active medical providers aged at least 18 years (N=1200) with access to an Internet-connected device. We will compare the effects of two experimental conditions reflecting cultivation and enabling effects of self-efficacy and perceived social support (sequential enhancement of resources), and two active controls strengthening self-efficacy or perceived social support. Job stress and job burnout will be the primary outcomes, whereas depression, job-related traumatic stress, and work engagement will be secondary ones. Additionally, we will measure perceived social support, self-efficacy to manage job stress and burnout, and the ability to obtain social support, exposure to traumatic events, and users expectancy and credibility of the intervention. All assessments will be applied before the intervention, atposttest (at 3 or 6weeks depending on the study condition), and at 6-month and 12-month follow up. In the case of experimental groups, additional measurements will be taken after enhancing each resource.DiscussionResource-based interventions are relatively context-free and could potentially benefit medical professionals across the field. If Med-Stress is successful, its most effective variant could be implemented in the healthcare system as a standalone, supportive tool for employees.Trial registrationClinicalTrials.gov, NCT03475290 Registered on 23 March 2018.

  • 20.
    Thomas, Kristin
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Bendtsen, Marcus
    Linköping University, Department of Computer and Information Science, Database and information techniques. Linköping University, Faculty of Science & Engineering.
    Linderoth, Catharina
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Karlsson, Nadine
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Bendtsen, Preben
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Local Health Care Services in West Östergötland, Department of Medical Specialist in Motala.
    Müssener, Ulrika
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Short message service (SMS)-based intervention targeting alcohol consumption among university students: study protocol of a randomized controlled trial2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, article id 156Article in journal (Refereed)
    Abstract [en]

    Background: Despite significant health risks, heavy drinking of alcohol among university students is a widespread problem; excessive drinking is part of the social norm. A growing number of studies indicate that short message service (SMS)-based interventions are cost-effective, accessible, require limited effort by users, and can enable continuous, real-time, brief support in real-world settings. Although there is emerging evidence for the effect of SMS-based interventions in reducing alcohol consumption, more research is needed. This study aims to test the effectiveness of a newly developed SMS-based intervention targeting excessive alcohol consumption among university and college students in Sweden. Methods: The study is a two-arm randomized controlled trial with an intervention (SMS programme) and a control (treatment as usual) group. Outcome measures will be investigated at baseline and at 3-month follow up. The primary outcome is total weekly alcohol consumption. Secondary outcomes are frequency of heavy episodic drinking, highest estimated blood alcohol concentration and number of negative consequences due to excessive drinking. Discussion: This study contributes knowledge on the effect of automatized SMS support to reduce excessive drinking among students compared with existing support such as Student Health Centres.

  • 21.
    Thomas, Kristin
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Bendtsen, Marcus
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Linderoth, Catharina
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Müssener, Ulrika
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    mHealth smoking cessation intervention among high-school pupils (NEXit Junior): study protocol for a randomized controlled trial2018In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, article id 648Article in journal (Refereed)
    Abstract [en]

    BackgroundMobile health (mHealth) interventions, using text messages to support high-school pupils to quit smoking, could be a novel and cost-effective approach. However, more research is needed, specifically to investigate long-term effectiveness. The study aims to evaluate the effectiveness of a newly developed mHealth intervention targeting smoking cessation among high-school pupils.MethodsThe study is a two-arm, randomized controlled trial with an intervention group (mHealth intervention) and a control group (treatment as usual: national smoking cessation help line). Outcome measures will be investigated at baseline and at 3, 6, and 12months follow-up. Primary outcome measures will be: prolonged abstinence and 4-week point prevalence of smoking abstinence. Secondary outcome measures will be: 7-day point prevalence of smoking abstinence; mean number of quit attempts since taking part in the study; number of uses of other smoking cessation services since first invitation to the study and number of cigarettes smoked weekly if still smoking.DiscussionHigh schools in Sweden are bound by law to offer a smoke-free environment. However, little effort has been made to offer support to pupils who wish to quit smoking; rather the emphasis is on prevention of uptake. The study will examine the effectiveness of a stand-alone mHealth intervention targeting smokers among high-school pupils.Trial registrationThe trial was not retrospectively registered and has been registered at ISRCTN with the unique identification number ISRCTN15396225. The trial was registered on 13 October 2017.

  • 22.
    Toft, Palle
    et al.
    Department Anaesthesiology and Intensive Care, Odense University Hospital, Sdr. Boulevard 29, DK - 5000 Odense C, Denmark .
    Olsen, Hanne Tanghus
    Department Anaesthesiology and Intensive Care, Svendborg Hospital, Valdemarsgade 5 5700 Svendborg, Denmark, .
    Jørgensen, Helene Korvenius
    Department Anaesthesiology and Intensive Care, Hospital Lillebaelt, Skovvangen 2-8, 6000 Kolding, Denmark .
    Strøm, Thomas
    Department Anaesthesiology and Intensive Care, Odense University Hospital, Sdr. Boulevard 29, DK - 5000 Odense C, Denmark .
    Nibro, Helle Lykkeskov
    Department Anaesthesiology and Intensive Care, Aarhus University Hospital Nørrebrogade 44, 8000 Aarhus, Denmark .
    Oxlund, Jacob
    Department Anaesthesiology and Intensive Care, Esbjerg Hospital, Frihedsvej 15, 6700 Esbjerg, Denmark .
    Wian, Karl-Andre
    Department Anaesthesiology and Intensive Care, Vestfold Hospital, Halfdan Wilhelmsens alle 17, 3116 Tonsberg, Norway. .
    Ytrebø, Lars Marius
    Department Anaesthesiology and Intensive Care, University Hospital of North Norway .
    Kroken, Bjørn Anders
    Department Anaesthesiology and Intensive Care, University Hospital of North Norway .
    Chew, Michelle
    8Department Anaesthesiology and Intensive Care, Hallands Hospital, Lasarettsvägen, 302 33 Halmstad, Sweden. .
    Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial): study protocol for a randomised controlled trial2014In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 15, no 499, p. 1-11Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level. No randomised trial has been conducted comparing sedation with no sedation, a priori powered to have all-cause mortality as primary outcome.The objective is to assess the benefits and harms of non-sedation versus sedation with a daily wake-up trial in critically ill patients.

    METHODS/DESIGN: The non-sedation (NONSEDA) trial is an investigator-initiated, randomised, clinical, parallel-group, multinational trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden.Inclusion criteria are mechanically ventilated patients with expected duration of mechanical ventilation >24 hours.Exclusion criteria are non-intubated patients, patients with severe head trauma, coma at admission or status epilepticus, patients treated with therapeutic hypothermia, patients with PaO2/FiO2 < 9 where sedation might be necessary to ensure sufficient oxygenation or place the patient in prone position.Experimental intervention is non-sedation supplemented with pain management during mechanical ventilation.Control intervention is sedation with a daily wake-up trial.The primary outcome will be all cause mortality at 90 days after randomization. Secondary outcomes will be: days until death throughout the total observation period; coma- and delirium-free days; highest RIFLE score; days until discharge from the intensive care unit (within 28 days); days until the participant is without mechanical ventilation (within 28 days); and proportion of patients with a major cardiovascular outcome. Explorative outcomes will be: all cause mortality at 28 days after randomisation; days until discharge from the intensive care unit; days until the participant is without mechanical ventilation; days until discharge from the hospital; organ failure.Trial size: we will include 700 participants (2 × 350) in order to detect or reject 25% relative risk reduction in mortality with a type I error risk of 5% and a type II error risk of 20% (power at 80%).

    DISCUSSION: The trial investigates potential benefits of non-sedation. This might have large impact on the future treatment of mechanically ventilated critically ill patients.

    TRIAL REGISTER: ClinicalTrials.gov NCT0196768, 09.01.2014.

  • 23.
    Tulbure, Bogdan Tudor
    et al.
    Babes-Bolyai University, Cluj-Napoca, Romania .
    Månsson, Kristoffer N T
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial2012In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 13, no 202Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Social anxiety disorder (SAD) is one of the most common anxiety disorders and is associated with marked impairments. However, a small proportion of individuals with SAD seek and receive treatment. Internet-administrated cognitive behavior therapy (iCBT) has been found to be an effective treatment for SAD. This trial will be the first Internet-delivered guided self-help intervention for SAD in Romania.

    METHODS: Participants with social anxiety disorder (N = 96) will be recruited via newspapers, online banners and Facebook. Participants will be randomized to either: a) an active treatment, or b) a waiting list control group.The treatment will have a guided iCBT format and will last for nine weeks. Self-report questionnaires on social phobia, anxiety, depression, treatment credibility and irrational thinking will be used. All assessments will be collected pre, post and at follow-up (six months after intervention). Liebowitz Social Anxiety Scale - Self-Report version (LSAS-SR) will be the primary outcome measure and will be administrated on a weekly basis in both conditions.

    DISCUSSION: The present randomized controlled trial investigates the efficacy of an Internet-administered intervention in reducing social anxiety symptoms in a culture where this form of treatment has not been tested. This trial will add to the body of knowledge on the efficacy of iCBT, and the results might lead to an increase of the accessibility of evidence-based psychological treatment in Romania.

    TRIAL REGISTRATION: ClinicalTrials.gov: NCT01557894.

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