AimsThe aim of this study was to develop and refine the content and design of an internet-based support and education program for patients awaiting kidney transplantation from deceased donors.DesignA Delphi process was used.MethodsA prototype internet-based intervention was drafted, based on previous research. The intervention included educational and psychological support to manage the uncertain waiting time and specific education enabling preparation for transplantation and adjustment to life after transplantation. In a two-round Delphi process, patients who had received a kidney transplant from a deceased donor within the last 2 years (n = 27), significant others (n = 6), health-care personnel with renal (n = 20) or transplant (n = 14) expertise, rated importance of content and design aspects of the prototype intervention on a 5-point scale using web questionnaires. A median of >= 3 was considered as consensus. Quantitative data was analyzed using descriptive statistics. Free text answers were encouraged and analyzed using deductive content analysis. The STROBE-checklist was used.ResultsConsensus was reached for all suggested content and design items in round 1, with median ratings of 4 or 5. Qualitative analysis from round 1 suggested four new content and design items which were rated in round 2, on all which consensus was reached; information about life with young children as relatives, expansion of kidney transplantation specific information, program extension by one week and individualization by making information available based on individual needs.ConclusionThere was consensus among heterogenous experts regarding suggested educational and psychological support content and design aspects, and additional content and design aspects were identified for an internet-based support and education program for patients awaiting kidney transplantation from deceased donors.

Aims and Objective To explore the experiences of patients with non-cardiac chest pain and cardiac anxiety regarding participation in an internet-delivered cognitive behavioural therapy program. Background Non-cardiac chest pain is common and leads to cardiac anxiety. Internet-delivered cognitive behavioural therapy may be a possible option to decrease cardiac anxiety in these patients. We have recently evaluated the effect of an internet-delivered cognitive behavioural therapy program on cardiac anxiety. Design An inductive qualitative study using content analysis and the COREQ checklist. Methods Semi-structured interviews with 16 Swedish patients, who had participated in the internet-delivered cognitive behavioural therapy program. Results Three categories were found. The first, Driving factors for participation in the internet-delivered cognitive behavioural therapy program described the impact of pain on their lives and struggle that led them to participating in the program. The second, The program as a catalyst described that the program was helpful, trustworthy and useful and the last category, Learning to live with chest pain described the program as a tool for gaining the strength and skills to live a normal life despite chest pain. Conclusions The program was experienced as an opportunity to return to a normal life. The program was perceived as helpful, trustworthy and useful, which helped the participants challenge their fear of chest pain and death, and gain strength and new insights into their ability to live a normal life. Relevance to Clinical Practice A tailored internet-delivered cognitive behavioural therapy program delivered by a nurse therapist with clinical experience of the patient group is important to improve cardiac anxiety. Patient or Public Contribution Patients or the general public were not involved in the design, analysis or interpretation of the data of this study, but two patients with experience of non-cardiac chest pain were involved in the development of the pilot study. Trial Registration NCT03336112; .

Aims The aims of this study were to evaluate: (i) the short- and long-term effects of the internet-based cognitive behaviour (iCBT) programme on symptoms of distress and fear disorder in cardiovascular disease (CVD) patients, and (ii) the association between changes in depression and changes in symptoms of distress and fear disorder from baseline to 12-month follow-up.Methods and results Secondary analysis of data collected in a randomized controlled study evaluating the effects on depression of an iCBT programme compared to an online discussion forum (ODF) in CVD patients (n = 144). Data were collected at baseline, at post-intervention (9 weeks), and at 6- and 12-month follow-ups. The results showed that symptoms of distress disorder were statistically significantly more reduced in the iCBT group than in the ODF group. For symptoms of the fear disorder, no differences were found except for avoidance, which showed a statistically significant reduction in the iCBT group. The long-term analysis in the iCBT group showed that CAQ total score and fear decreased from baseline to 6- and 12-month follow-ups, respectively. Avoidance and attention both decreased statistically significantly from baseline to post-intervention, but not between post-intervention and 12-month follow-up.Methods and results Secondary analysis of data collected in a randomized controlled study evaluating the effects on depression of an iCBT programme compared to an online discussion forum (ODF) in CVD patients (n = 144). Data were collected at baseline, at post-intervention (9 weeks), and at 6- and 12-month follow-ups. The results showed that symptoms of distress disorder were statistically significantly more reduced in the iCBT group than in the ODF group. For symptoms of the fear disorder, no differences were found except for avoidance, which showed a statistically significant reduction in the iCBT group. The long-term analysis in the iCBT group showed that CAQ total score and fear decreased from baseline to 6- and 12-month follow-ups, respectively. Avoidance and attention both decreased statistically significantly from baseline to post-intervention, but not between post-intervention and 12-month follow-up.Conclusion The results suggest that the iCBT programme targeted depression in CVD patients successfully reduced symptoms of distress disorder and to a lesser extent symptoms of fear disorder. Change in depression was more strongly associated with a change in distress than a change in fear disorder.Registration ClinicalTrials.gov: NCT02778074 Graphical Abstract

Introduction Cost-effectiveness evaluations of psychological interventions, such as internet-delivered cognitive behavioural therapy (iCBT) programmes, in patients with cardiovascular disease (CVD) are rare. We recently reported moderate to large effect sizes on depressive symptoms in CVD outpatients following a 9-week iCBT programme compared with an online discussion forum (ODF), in favour of iCBT. In this paper, we evaluate the cost-effectiveness of this intervention.

Methods Cost-effectiveness analysis of a randomised controlled trial. The EQ-5D-3L was used to calculate quality-adjusted life-years (QALYs). Data on healthcare costs were retrieved from healthcare registries.

Results At 12-month follow-up, the QALY was significantly higher in iCBT compared with the ODF group (0.713 vs 0.598, p=0.007). The mean difference of 0.115 corresponds with 42 extra days in best imaginable health status in favour of the iCBT group over the course of 1 year. Incremental cost-effectiveness ratio (ICER) for iCBT versus ODF was euro18 865 per QALY saved. The cost-effectiveness plane indicated that iCBT is a cheaper and more effective intervention in 24.5% of the cases, and in 75% a costlier and more effective intervention than ODF. Only in about 0.5% of the cases, there was an indication of a costlier, but less effective intervention compared with ODF.

Conclusions The ICER of euro18 865 was lower than the cost-effectiveness threshold range of euro23 400-euro35 100 as proposed by the NICE guidelines, suggesting that the iCBT treatment of depressive symptoms in patients with CVD is cost-effective.

BACKGROUND: Internet-based cognitive behavioural treatment (iCBT) has shown positive short-term effects on depression in patients with cardiovascular disease (CVD). However, knowledge regarding long-term effects and factors that may impact the effect of iCBT is lacking.

AIMS: This study therefore sought (i) to evaluate the effect of iCBT on depression in CVD patients at 6- and 12-month follow-ups and (ii) to explore factors that might impact on the effect of iCBT on change in depression at 12-month follow-up.

METHODS AND RESULTS: A longitudinal follow-up study of a randomized controlled trial evaluating the effects of a 9-week iCBT programme compared to an online discussion forum (ODF) on depression in CVD patients (n = 144). After 9 weeks, those in the ODF group were offered the chance to take part in the iCBT programme. The Patient Health Questionnaire (PHQ-9) and the Montgomery-Åsberg Depression Rating Scale-self-rated version (MADRS-S) measured depression at baseline, 9 weeks, 6 months, and 12 months. Linear mixed model and multiple regression analysis were used for statistical computing. The iCBT programme significantly improved depression at 9-week follow-up and this was stable at 6- and 12-month follow-ups (PHQ-9 P = 0.001, MADRS-S P = 0.001). Higher levels of depression at baseline and a diagnosis of heart failure were factors found to impact the effect of iCBT on the change in depression.

CONCLUSION: A 9-week iCBT programme in CVD patients led to long-term improvement in depression. Higher levels of depression scores at baseline were associated with improvement in depression, whereas heart failure had opposite effect.

CLINICAL TRIAL: The trial is registered at ClinicalTrials.gov, NCT02778074.

Background: In patients with cardiovascular disease (CVD), knowledge about the associations among changes in depressivesymptoms, self-efficacy, and self-care activities has been requested. This is because such knowledge can be helpful in the designof behavioral interventions aimed to improve self-efficacy, reduce depressive symptoms, and improve performance of self-careactivities in CVD patients.

Objective: We aim to evaluate if internet-based cognitive behavioral therapy (iCBT) improves self-efficacy and explore therelationships among changes in depressive symptoms, self-efficacy, and physical activity, as well as the influence of iCBT onthese relationships.

Methods: This study received funding in January 2015. Participant recruitment took place between January 2017 and February2018, and the main findings were published in 2019. This study is a secondary analysis of data collected in a randomized controlledstudy evaluating the effects of a 9-week iCBT program compared to an online discussion forum (ODF) on depressive symptomsin patients with CVD (N=144). Data were collected at baseline and at the 9-week follow-up. Analysis of covariance was used toevaluate the differences in self-efficacy between the iCBT and ODF groups. Structural equation modeling explored the relationshipsamong changes in depressive symptoms, self-efficacy, and physical activity, as well as the influence of iCBT on these relationships.

Results: At follow-up, a significant difference in the increase in self-efficacy favoring iCBT was found (P=.04, Cohen d=0.27).We found an indirect association between changes in depressive symptoms and physical activity (ß=–.24, P<.01), with the changein self-efficacy acting as a mediator. iCBT had a direct effect on the changes in depressive symptoms, which in turn influencedthe changes in self-efficacy (ß=.23, P<.001) and physical activity (ß=.12, P<.001).

Conclusions: Self-efficacy was improved by iCBT. However, the influence of iCBT on self-efficacy and physical activity wasmostly mediated by improvements in depressive symptoms.Trial Registration: ClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074

BACKGROUND: Increasing life spans of populations and a growing demand for more advanced care make effective and cost-efficient provision of health care necessary. eHealth technology is often proposed, although research on barriers to and facilitators of the implementation of eHealth technology is still scarce and fragmented.

OBJECTIVE: The aim of this study is to explore the perceptions concerning barriers to and facilitators of the implementation of eHealth among policy makers and service users and explore the ways in which their perceptions converge and differ.

METHODS: This study used interview data from policy makers at different levels of health care (n=7) and service users enrolled in eHealth interventions (n=25). The analysis included separate qualitative content analyses for the 2 groups and then a second qualitative content analysis to explore differences and commonalities.

RESULTS: Implementation barriers perceived by policy makers were that not all service users benefit from eHealth and that there is uncertainty about the impact of eHealth on the work of health care professionals. Policy makers also perceived political decision-making as complex; this included problems related to provision of technical infrastructure and lack of extra resources for health care digitalization. Facilitators were policy makers' conviction that eHealth is what citizens want, their belief in eHealth solutions as beneficial for health care practice, and their belief in the importance of health care digitalization. Barriers for service users comprised capability limitations and varied preferences of service users and a mismatch of technology with user needs, lack of data protection, and their perception of eHealth as being more time consuming. Facilitators for service users were eHealth technology design and match with their skill set, personal feedback and staff support, a sense of privacy, a credible sender, and flexible use of time.There were several commonalities between the 2 stakeholder groups. Facilitators for both groups were the strong impetus toward technology adoption in society and expectations of time flexibility. Both groups perceived barriers in the difficulties of tailoring eHealth, and both groups expressed uncertainty about the care burden distribution. There were also differences: policy makers perceived that their decision-making was very complex and that resources for implementation were limited. Service users highlighted their need to feel that their digital data were protected and that they needed to trust the eHealth sender.

CONCLUSIONS: Perceptions about barriers to and facilitators of eHealth implementation varied among stakeholders in different parts of the health care system. The study points to the need to reach an enhanced mutual understanding of priorities and overcome challenges at both the micro and macro levels of the health care system. More well-balanced decisions at the policy-maker level may lead to more effective and sustainable development and future implementation of eHealth.

Background: Depression in conjunction with cardiovascular disease (CVD) is associated with worsening in CVD, higher mortality, and poorer quality of life. Despite the poor outcomes there is a treatment gap of depression in CVD patients. Recently we found that an Internet-based cognitive behavioral therapy (iCBT) tailored for CVD patients led to reduced symptoms of depression. However, we still have little knowledge about CVD patients experiences of working with iCBT. The aim of this study was therefore to explore CVD patients experiences of engaging in a tailored iCBT program.

Methods: A qualitative interview study using inductive thematic analysis. Data was obtained from 20 patients with CVD and depressive symptoms who had participated in a randomized controlled trial (RCT) evaluating the impact of a nine-week iCBT program on depression.

Results: Three main themes emerged: (1) Taking control of the disease, (2) Not just a walk in the park, and (3) Feeling a personal engagement with the iCBT program. The first theme included comments that the tailored program gave the patients a feeling of being active in the treatment process and helped them achieve changes in thoughts and behaviors necessary to take control of their CVD. The second theme showed that patients also experienced the program as demanding and emotionally challenging. However, it was viewed as helpful to challenge negative thinking about living with CVD and to change depressive thoughts. In the third theme patients reported that the structure inherent in the program, in the form of organizing their own health and the scheduled feedback from the therapist created a feeling of being seen as an individual. The feeling of being acknowledged as a person also made it easier to continuously work with the changes necessary to improve their health.

Conclusions: Engaging in an iCBT program tailored for patients with CVD and depression was by the patients perceived as helpful in the treatment of depression. They experienced positive changes in emotions, thoughts, and behaviors which a result of learning to take control of their CVD, being confirmed and getting support. The patients considered working with the iCBT program as demanding and emotionally challenging, but necessary to achieve changes in emotions, thoughts, and behaviors.

Objectives: The study aimed to explore and describe patients’ experiences of the transplantation process and the support they had received during the waiting time.

Method: Semi-structured interviews were conducted with 14 patients currently waiting for kidney transplantation from deceased donors (n = 7) or recently having received kidney transplantation (n = 7). Interviews were transcribed, anonymized and analysed inductively using thematic analysis.

Results: Two themes and seven sub-themes were identified. The first theme, “Swaying between hope and despair” describes patients’ perceptions of waiting for transplantation as a struggle, their expectations for life after the upcoming transplantation and experienced disappointments. The second theme, “Making your way through the waiting time”, describes support, strategies and behaviours used to manage the waiting time.

Conclusion: Patients described life while waiting for kidney transplantation as challenging, involving unexpected events, not understanding the transplantation process and having unrealistic expectations on life after transplantation. They also described support, strategies and behaviours used, some of which led to unwanted consequences.

Practice implications: Patients waiting for kidney transplantation from deceased donors need continuous and easily available education, practical and emotional support to manage the waiting time. Transplantation specific education is also needed to facilitate preparation for transplantation and adjustment to life after transplantation.

Background: As patients are increasingly searching for information about their medical condition on the internet, there is a need for health professionals to be able to guide patients toward reliable and suitable information sources on the internet.

Objective: The aim of the study was to develop a clinical tool for health care professionals to assess the usability and quality of the content of websites containing medical information that could be recommended to patients.

Methods: A 3-round modified electronic Delphi (eDelphi) study was conducted with 20 health care professionals.

Results: In round one of the eDelphi study, of the 68 items initially created, 41 items (29 on usability and 12 on content) were rated as important or very important by more than half of the panel and thus selected for further evaluation in round two. In round two, of the 41 items chosen from round 1, 19 were selected (9 on usability and 10 on content) as important or very important by more than half of the panel for further evaluation. As a result of round three, 2 items were combined as a single item, leaving the instrument with 18 items in total (8 on usability and 10 on content). The tool is freely accessible online.

Conclusions: The CUE-tool can be used to (1) evaluate the usability and reliability of the content of websites before recommending them to patients as a good information source; (2) identify websites that do not have reliable content or may be difficult for patients to use; (3) develop quality websites by using the criteria in the CUE-tool; and (4) identify different qualities between different websites.

BACKGROUND: Internet cognitive behavioural therapy (iCBT) is a viable delivery format of CBT for depression. However, iCBT programmes include training in a wide array of cognitive and behavioural skills via different delivery methods, and it remains unclear which of these components are more efficacious and for whom.

METHODS: We did a systematic review and individual participant data component network meta-analysis (cNMA) of iCBT trials for depression. We searched PubMed, PsycINFO, Embase, and the Cochrane Library for randomised controlled trials (RCTs) published from database inception to Jan 1, 2019, that compared any form of iCBT against another or a control condition in the acute treatment of adults (aged ≥18 years) with depression. Studies with inpatients or patients with bipolar depression were excluded. We sought individual participant data from the original authors. When these data were unavailable, we used aggregate data. Two independent researchers identified the included components. The primary outcome was depression severity, expressed as incremental mean difference (iMD) in the Patient Health Questionnaire-9 (PHQ-9) scores when a component is added to a treatment. We developed a web app that estimates relative efficacies between any two combinations of components, given baseline patient characteristics. This study is registered in PROSPERO, CRD42018104683.

FINDINGS: We identified 76 RCTs, including 48 trials contributing individual participant data (11 704 participants) and 28 trials with aggregate data (6474 participants). The participants' weighted mean age was 42·0 years and 12 406 (71%) of 17 521 reported were women. There was suggestive evidence that behavioural activation might be beneficial (iMD -1·83 [95% credible interval (CrI) -2·90 to -0·80]) and that relaxation might be harmful (1·20 [95% CrI 0·17 to 2·27]). Baseline severity emerged as the strongest prognostic factor for endpoint depression. Combining human and automated encouragement reduced dropouts from treatment (incremental odds ratio, 0·32 [95% CrI 0·13 to 0·93]). The risk of bias was low for the randomisation process, missing outcome data, or selection of reported results in most of the included studies, uncertain for deviation from intended interventions, and high for measurement of outcomes. There was moderate to high heterogeneity among the studies and their components.

INTERPRETATION: The individual patient data cNMA revealed potentially helpful, less helpful, or harmful components and delivery formats for iCBT packages. iCBT packages aiming to be effective and efficient might choose to include beneficial components and exclude ones that are potentially detrimental. Our web app can facilitate shared decision making by therapist and patient in choosing their preferred iCBT package.

FUNDING: Japan Society for the Promotion of Science.

BACKGROUND: Depressive symptoms are common in patients with cardiovascular disease (CVD) and are associated with a poorer quality of life and prognosis. Despite the high prevalence and negative consequences, the recognition of depressive symptoms is low. More knowledge about patients' perceptions of how depressive symptoms are addressed by healthcare professionals is therefore needed.

OBJECTIVES: The aim of this study was to explore the experiences of patients with CVD of how healthcare professionals address and manage depressive symptoms in clinical cardiac care encounters.

METHODS: A qualitative, semistructured interview study was performed. Data were analyzed using inductive thematic analysis.

RESULTS: In total, 20 patients with CVD previously treated for depressive symptoms were included (mean age, 62 [range, 34-79] years; 45% women). Three main themes emerged: (1) "not being seen as a whole person," (2) "denying depressive symptoms," and (3) "being provided with help." The patients perceived that healthcare professionals mainly focused on somatic symptoms and disregarded their need for help for depressive symptoms when patients raised the issue. Some patients stated that they received help for depressive symptoms, but this depended on the patients' own ability to communicate their needs and/or having social support that could alert them to the importance of doing so. Patients also described that they downplayed the burden of depressive symptoms and/or did not recognize themselves as having depressive symptoms.

CONCLUSION: Depressive symptoms were overlooked in patients with CVD, and psychological needs had not been met. A good ability to address needs and having good social support were useful for receiving help with depressive symptoms.

BACKGROUND: Patients with chronic heart failure may require treatment of depressive symptoms to improve self-care behaviour.

OBJECTIVES: To investigate the impact of internet-based cognitive behavioral therapy (CBT) on self-care behaviour in heart failure patients, and to study the association between changes in depressive symptoms and changes in self-care behaviour.

DESIGN: A secondary analysis of data collected in a pilot randomized controlled study.

SETTING: 50 heart failure patients with depressive symptoms were recruited from four hospitals in Sweden.

METHODS: Patients were randomized to nine weeks of internet-based CBT (n = 25) or to an active control group participating in an online discussion forum (n = 25). In week two and three, those in the internet-based CBT group worked with psychoeducation about heart failure and depression, emphasizing heart failure self-care. During the same weeks those in the on-line discussion forum specifically discussed heart failure self-care. Patient Health Questionnaire-9 was used to measure depressive symptoms at baseline and at the nine-week follow-up. The European Heart Failure Self-care Behaviour Scale-9 was used to measure self-care behaviour (i.e., the summary score and the subscales autonomous based, provider based and consulting behaviour) at baseline, and at the three-week and nine-week follow-ups.

RESULTS: No significant differences were found in self-care between the patients in the internet-based CBT and the patients in the online discussion group at the three- and nine-week follow-up. Within-group analysis of the changes in the European Heart Failure Self-care Behaviour Scale showed that from baseline to week three, the summary score increased significantly for the online discussion group (p = 0.04), but not for the internet-based CBT group (p = 0.15). At the nine-week follow-up, these scores had decreased. Similarly, consulting behaviour improved at week three for the online discussion group (p = 0.04), but not for the internet-based CBT group (p = 0.22). Provider-based adherence at the nine-week follow-up had increased from baseline in the internet-based CBT group (p = 0.05) whereas it had decreased in the on-line discussion group. Improvement in symptoms of depression was significantly associated with improvement in autonomy-based self-care (r = 0.34, p = 0.03).

CONCLUSION: Improvement in depressive symptoms was associated with improved autonomous-based self-care. ICBT for depression in HF may benefit aspects of self-care that are vital to improve symptoms and prognosis.

Background: There is a lack of knowledge about internet-based cognitive behavioural therapy in patients with cardiovascular disease, and its effects on depressive symptoms and physical activity. Aim: To examine trajectories of depressive symptoms and physical activity, and to explore if these trajectories are linked with the delivery of internet-based cognitive behavioural therapy. Methods: A secondary-analysis of data collected in a randomised controlled trial that evaluated the effects of a 9-week internet-based cognitive behavioural therapy programme compared to an online discussion forum on depressive symptoms in cardiovascular disease patients. Data were collected at baseline, once weekly during the 9-week intervention period and at the 9-week follow-up. The Montgomery angstrom sberg depression rating scale - self-rating (MADRS-S) was used to measure depressive symptoms. Two modified items from the physical activity questionnaire measuring frequency and length of physical activity were merged to form a physical activity factor. Results: After 2 weeks the internet-based cognitive behavioural therapy group had a temporary worsening in depressive symptoms. At 9-week follow-up, depressive symptoms (P&lt;0.001) and physical activity (P=0.02) had improved more in the internet-based cognitive behavioural therapy group. Only in the internet-based cognitive behavioural therapy group, was a significant correlation (r=-0.39,P=0.002) between changes in depressive symptoms and changes in physical activity found. Structural equation analyses revealed that internet-based cognitive behavioural therapy decreased depressive symptoms, and that a decrease in depression, in turn, resulted in an increase in physical activity. Conclusions: Internet-based cognitive behavioural therapy was more effective than an online discussion forum to decrease depressive symptoms and increase physical activity. Importantly, a decrease in depressive symptoms needs to precede an increase in physical activity.

Background

Sleep is essential for health and recovery. Hospital stays may affect adolescents’ sleep quality negatively as routines in the ward are not adapted for adolescents’ developmental status or sleep habits. The aims with this study were to (a) explore and describe how adolescents experience sleep in the family-centered pediatric ward, (b) explore and describe how adolescents experience the presence or absence of a parent during the hospital stay, and (c) identify circumstances that the adolescents describe as influential of their sleep in the pediatric wards.

Methods

This is a qualitative interview study employing thematic analysis with an inductive and exploratory approach. Sixteen adolescents aged between 13 and 17 years participated in the study.

Results

Three themes were found: the importance of good sleep, safety as a prerequisite for sleep in hospital, and circumstances influencing adolescents’ sleep in hospital.

Conclusion

The adolescents described their sleep at the pediatric ward positively, but mentioned disturbing factors associated with pain, nightly check-ups, noises, and inactivity. Parental presence was perceived as very positive both during the night and the day.

BACKGROUND: Depression is a common cause of reduced well-being and prognosis in patients with cardiovascular disease (CVD). However, there is a lack of effective intervention strategies targeting depression.

OBJECTIVE: The study aimed to evaluate the effects of a nurse-delivered and adapted internet-based cognitive behavioral therapy (iCBT) program aimed at reducing depression in patients with CVD.

METHODS: A randomized controlled trial was conducted. A total of 144 patients with CVD with at least mild depression (Patient Health Questionnaire-9 [PHQ-9] score ≥5) were randomized 1:1 to a 9-week program of iCBT (n=72) or an active control participating in a Web-based discussion forum (online discussion forum [ODF], n=72). The iCBT program, which included 7 modules, was adapted to fit patients with CVD. Nurses with an experience of CVD care provided feedback and a short introduction to cognitive behavioral therapy. The primary outcome, depression, was measured using PHQ-9. Secondary outcomes were depression measured using the Montgomery-Åsberg Depression Rating Scale-self-rating version (MADRS-S), health-related quality of life (HRQoL) measured using Short Form 12 (SF-12) survey and EuroQol Visual Analogue Scale (EQ-VAS), and the level of adherence. An intention-to-treat analysis with multiple imputations was used. Between-group differences in the primary and secondary outcomes were determined by the analysis of covariance, and a sensitivity analysis was performed using mixed models.

RESULTS: Compared with ODF, iCBT had a significant and moderate treatment effect on the primary outcome depression (ie, PHQ-9; mean group difference=-2.34 [95% CI -3.58 to -1.10], P<.001, Cohen d=0.62). In the secondary outcomes, compared with ODF, iCBT had a significant and large effect on depression (ie, MADRS-S; P<.001, Cohen d=0.86) and a significant and moderate effect on the mental component scale of the SF-12 (P<.001, Cohen d=0.66) and the EQ-VAS (P<.001, Cohen d=0.62). Overall, 60% (n=43) of the iCBT group completed all 7 modules, whereas 82% (n=59) completed at least half of the modules. No patients were discontinued from the study owing to a high risk of suicide or deterioration in depression.

CONCLUSIONS: Nurse-delivered iCBT can reduce depression and improve HRQoL in patients with CVD, enabling treatment for depression in their own homes and at their preferred time.

TRIAL REGISTRATION: ClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074.

Background

Few studies have investigated the trajectory of depression and level of physical activity, in patients with heart disease during a psychosocial intervention such as internet based cognitive behavioural therapy (iCBT). For health care professionals in cardiac care it is important to know when an improvement in depression can be expected during iCBT and if this improvement can be associated with physical activity. The aim of this study therefore is, 1) to investigate the trajectory of depression and physical activity during participation in an iCBT program compared to a moderated online discussion forum (ODF). 2) to investigate the association between improvements in depression and physical activity.

Method

A sub-analysis of data collected in a randomised controlled trial (RCT) that evaluated the effect on depression of a nine-week iCBT program guided by nurse. In the RCT, 144 cardiac patients with at least mild depression were randomised to iCBT or ODF. The iCBT program consisted of seven modules where feedback was provided by nurses. The ODF consisted of nine discussion topics moderated by a nurse.

Data for the present analysis was collected at baseline, once weekly during the intervention period, and the follow-up. Depression was measured by Montgomery Åsberg Depression Rating Scale – self rating (MADRS-S). Two modified items from the Physical Activity Questionnaire measured frequency and length of physical activity. Frequency was scored between “none of the days” (0) to “often, 5-7 days” (3). Length was scored from 0 (0 minutes) to 4 (more than 60 minutes). A combined physical activity factor was calculated by multiplying frequency and length scores.

Results

Figure 1a illustrates the trajectory of depression from baseline assessment until the follow up. There was a significant time and group interaction (F=9.98, p<.001, η²=.106) favouring iCBT. The significant difference in depression between iCBT and ODF started at week six and remained to the follow-up. Figures 1b to 1d illustrates the trajectories of physical activity. We found a significant interaction of time and group favouring iCBT for the combined physical factor (F=2.36, p=0.019, η²=.028). The interaction effects for time and group for frequency (F=1.95, p=0.056) and length in physical activity (F=1.26, p=0.272) was not statistically significant. Pearson correlational analyses showed a positive association between improvement in depression and increase of physical activity (r=.256, p=.004). For the iCBT-group this association was stronger (r= .312, p=.011), whereas there was no significant correlation in the ODF group (r= -.006, p= .965)

Conclusion

Both depression and physical activity improved during the course of the nine week iCBT program. However, improvement occur more clearly after half the duration of iCBT program. Early in the program, a temporary worsening of depression was seen. This indicates that patients need support and encouragement to complete the iCBT program, which gives them greater opportunities to improve in depression and physical activity.

Introduction

The prevalence of depressive symptoms in persons with heart failure is higher than in age- and gender-matched populations not suffering from heart failure. Heart failure in itself is associated with an unpredictable trajectory of symptoms, a poor prognosis, high mortality and morbidity, and low health-related quality of life (HrQoL). With the addition of depressive symptoms to heart failure the negative health effects increase further. Though the negative consequences of depressive symptoms in heart failure are well known, there is a knowledge gap about the course of depressive symptoms in heart failure and about how to effectively manage these symptoms. Pharmacological treatment with serotonin reuptake inhibitors has not been able to demonstrate efficacy in persons with heart failure. In a few studies, cognitive behavioural therapy (CBT) delivered face-to-face, has demonstrated effects on depressive symptoms in persons with heart failure. However, currently there are barriers in delivering face-to-face CBT as there is a lack of therapists with the required training. As a solution to this, the use of Internet-based CBT (ICBT) has been proposed. ICBT has been shown to be effective in treatment of mild and moderate depression but has not been evaluated in persons with heart failure.

Aim

The overall aim of this thesis was to describe depressive symptoms over time and to develop and evaluate an ICBT intervention to treat depressive symptoms in persons with heart failure.

Design and Methods

The studies in this thesis employ both quantitative (Studies I, II and III) and qualitative (Studies II and IV) research methods. The sample in Study I (n=611) were recruited in the Netherlands. The participants (n=7) in Study II were recruited via advertisements in Swedish newspapers. Studies III and IV used the same cohort of participants (Study III n=50, Study IV n=13). These participants were recruited via an invitation letter sent to all persons who had made contact with healthcare services in relation to heart failure during the previous year, at the clinics of cardiology or medicine in four hospitals in southeast Sweden.

Study I had a quantitative longitudinal design. Data on depressive symptoms was collected at baseline (discharge from hospital) and after 18 months. Data on mortality and hospitalisation was collected at 18 and 36 months after discharge from hospital. Study II employed three differentBehind the Screen2patterns of design, as follows: I) The development and context adaptation of the ICBT program was based on research, literature and clinical experience and performed within a multi-professional team. II) The feasibility of the program from the perspective of limited efficacy and function was investigated with a quantitative pre-post design. III) Participants’ experience of the ICBT program was investigated with a qualitative content analysis. Data on depressive symptoms was collected pre and post intervention. The time used for support and feedback was logged during the intervention, and qualitative interviews were performed with the participants after the end of the intervention. Study III was designed as a randomised controlled trial. A nine-week ICBT program adapted to persons with heart failure and depressive symptoms was tested against an online moderated discussion forum. Data on depressive symptoms, HrQoL and cardiac anxiety was collected at baseline (before the intervention started) and after the end of the intervention (approximately 10 weeks after the start of the intervention). Study IV had a qualitative design to explore and describe participants’ experiences of ICBT. The participants were recruited from within the sample in Study III and all had experience of ICBT. Data collection occurred after the ICBT program ended and was carried out using qualitative interviews by telephone.

Results

The mean age of the samples used in this thesis varied between 62 and 69 years of age. Concerning the symptom severity of heart failure, most persons reported New York Heart Association (NYHA) class II (40-57%) followed by NYHA class III (36-41%). Ischaemic heart disease was the most common comorbidity (36-43%). The vast majority had pharmacological treatment for their heart failure. Six percent of the persons in Study I used pharmacological antidepressants. In Studies II and III, the corresponding numbers were 43% and 18% respectively.

Among persons hospitalised due to heart failure symptoms, 38% reported depressive symptoms. After 18 months, 26% reported depressive symptoms. Four different courses of depressive symptoms were identified: 1) Non-depressed 2) Remitted depressive symptoms. 3) Ongoing depressive symptoms. 4) New depressive symptoms. The highest risk for readmission to hospital and mortality was found among persons in the groups with ongoing and new depressive symptoms.

A nine-week ICBT program consisting of seven modules including homework assignments on depressive symptoms for persons with heart failure was developed and tested. The RCT study (Study III) showed no significant difference in depressive symptoms between ICBT and a moderated discussion forum. Within-group analysis of depressive symptoms demonstrated a significant decrease of depressive symptoms in the ICBT group but not in the discussion forum group.

The participants’ experience of ICBT was described in one theme: ICBT- an effective, but also challenging tool for self-management of health problems. This theme was constructed based on six categories: Something other than usual healthcare; Relevance and recognition; Flexible, understandable and safe; Technical problems; Improvements by live contact; Managing my life better.

Conclusion

After discharge from hospital, depressive symptoms decrease spontaneously among a large proportion of persons with heart failure, though depressive symptoms are still common in persons with heart failure that are community dwelling. Depressive symptoms in persons with heart failure are associated with increased risk of death and hospitalisation. The highest risks are found among persons with long-term ongoing depressive symptoms and those developing depressive symptoms while not hospitalised.

ICBT for depressive symptoms in heart failure is feasible. An intervention with a nine-week guided self-help program with emphasis on behavioural activation and problem-solving skills appears to contribute to a decrease in depressive symptoms and improvement of HrQoL.

When ICBT is delivered to persons with heart failure and depressive symptoms the participants requests that the ICBT is contextually adapted to health problems related to both heart failure and depressive symptoms. ICBT is experienced as a useful tool for self-care and something other than usual healthcare. ICBT also requires active participation by the persons receiving the intervention, something that was sometimes experienced as challenging.

Background: Web-based cognitive behavioral therapy (wCBT) has been proposed as a possible treatment for patients with heart failure and depressive symptoms. Depressive symptoms are common in patients with heart failure and such symptoms are known to significantly worsen their health. Although there are promising results on the effect of wCBT, there is a knowledge gap regarding how persons with chronic heart failure and depressive symptoms experience wCBT. Objective: The aim of this study was to explore and describe the experiences of participating and receiving health care through a wCBT intervention among persons with heart failure and depressive symptoms. Methods: In this qualitative, inductive, exploratory, and descriptive study, participants with experiences of a wCBT program were interviewed. The participants were included through purposeful sampling among participants previously included in a quantitative study on wCBT. Overall, 13 participants consented to take part in this study and were interviewed via telephone using an interview guide. Verbatim transcripts from the interviews were qualitatively analyzed following the recommendations discussed by Patton in Qualitative Research amp; Evaluation Methods: Integrating Theory and Practice. After coding each interview, codes were formed into categories. Results: Overall, six categories were identified during the analysis process. They were as follows: "Something other than usual health care," "Relevance and recognition," "Flexible, understandable, and safe," "Technical problems," "Improvements by real-time contact," and "Managing my life better." One central and common pattern in the findings was that participants experienced the wCBT program as something they did themselves and many participants described the program as a form of self-care. Conclusions: Persons with heart failure and depressive symptoms described wCBT as challenging. This was due to participants balancing the urge for real-time contact with perceived anonymity and not postponing the work with the program. wCBT appears to be a valuable tool for managing depressive symptoms.

BACKGROUND: Depressive symptoms, and the associated coexistence of symptoms of anxiety and decreased quality of life (QoL), are common in patients with heart failure (HF). However, treatment strategies for depressive symptoms in patients with HF still remain to be established. Internet-based cognitive behavioral therapy (ICBT), as guided self-help CBT programs, has shown good effects in the treatment of depression. Until now, ICBT has not been evaluated in patients with HF with depressive symptoms.

OBJECTIVE: The aims of this study were to (1) evaluate the effect of a 9-week guided ICBT program on depressive symptoms in patients with HF; (2) investigate the effect of the ICBT program on cardiac anxiety and QoL; and (3) assess factors associated with the change in depressive symptoms.

METHODS: Fifty participants were randomized into 2 treatment arms: ICBT or a Web-based moderated discussion forum (DF). The Patient Health Questionnaire-9 was used to measure depressive symptoms, the Cardiac Anxiety Questionnaire (CAQ) was used to measure cardiac-related anxiety, and the Minnesota Living with Heart Failure questionnaire was used to measure QoL. Data were collected at baseline and at follow-up at the end of the 9-week intervention. Intention-to-treat analysis was used, and missing data were imputed by the Expectation-Maximization method. Between-group differences were determined by analysis of covariance with control for baseline score and regression to the mean.

RESULTS: No significant difference in depressive symptoms between the ICBT and the DF group at the follow-up was found, [F(1,47)=1.63, P=.21] and Cohen´s d=0.26. Secondary within-group analysis of depressive symptoms showed that such symptoms decreased significantly in the ICBT group from baseline to the follow-up (baseline M=10.8, standard deviation [SD]=5.7 vs follow-up M=8.6, SD=4.6, t(24)=2.6, P=.02, Cohen´s d=0.43), whereas in the DF group, there was no significant change (baseline M=10.6, SD=5.0, vs follow-up M=9.8, SD=4.3, t(24)=0.93, P=.36. Cohen´s d=0.18). With regard to CAQ and QoL no significant differences were found between the groups (CAQ [d(1,47)=0.5, P=.48] and QoL [F(1,47)=2.87, P=.09]). In the ICBT group in the CAQ subscale of fear, a significant within-group decrease was shown (baseline M=1.55 vs follow-up M=1.35, P=.04). In the ICBT group, the number of logins to the Web portal correlated significantly with improvement in depressive symptoms (P=.02), whereas higher age (P=.01) and male sex (P=.048) were associated with less change in depressive symptoms. This study is underpowered because of difficulties in the recruitment of patients.

CONCLUSIONS: Guided ICBT adapted for persons with HF and depressive symptoms was not statistically superior to participation in a Web-based DF. However, within the ICBT group, a statically significant improvement of depressive symptoms was detected.

CLINICALTRIAL: Clinicaltrials.gov NCT01681771; https://clinicaltrials.gov/ct2/show/NCT01681771 (Archived by WebCite at http://www.webcitation.org/6ikzbcuLN).

Background: Depressive symptoms, and the associated coexistence of symptoms of anxiety and decreased quality of life (QoL), are a common problem in patients with heart failure (HF). However, treatment strategies for depressive symptoms in patients with HF still remain to be established. Cognitive behavioral therapy (CBT) and its Internet-based version as guided self-help CBT programs (ICBT) have shown good effects in the treatment of depression, but ICBT has not previously been evaluated in patients with HF and depressive symptoms. Objective: The aims of this study were to: (I) evaluate the effect of a nine-week ICBT program on depressive symptoms in patients with HF; (II) to assess factors associated with the change in depressive symptoms; and (III) to investigate the effect of the ICBT program on cardiac anxiety and QoL. Methods: Fifty participants were included and randomized into two treatment arms: ICBT or an online moderated discussion forum (DF). The Patient Health Questionnaire -9 (PHQ-9) was used to measure depressive symptoms, the Cardiac Anxiety Questionnaire (CAQ) was used to measure cardiac-related anxiety, and the Minnesota Living with Heart Failure questionnaire (MLHF) was used to measure QoL. Data were collected at baseline and at the nine-week follow-up. Results: In the ICBT group, depressive symptoms (M=10.8 vs. M=8.6, P=.02) and cardiac anxiety in the subscale of fear (M=1.55 vs. M=1.35, P=.04) improved significantly. QoL improved in the ICBT group by 6 points in the total score and 2.4 points in the physical factor, but this was not significant (P=.09 and P=.12). In the DF group, only a small reduction in the level of depressive symptoms was detected (M =10.6 SD=5.0, vs. M=9.8 SD=4.3, P=.36). Despite improvement in the ICBT group this was not significantly different compared to the DF group (ANCOVA analyses: depressive symptoms, P=.21; cardiac-related anxiety subscale of fear, P=.22; QoL total scale score, P=.09 and physical factors, P=.07). In the ICBT group, the number of logins to the web-portal correlated significantly with improvement in depressive symptoms (P=.02), whereas higher age (P=.01) and male sex (P=.048) were associated with less change in depressive symptoms. Conclusions: Guided ICBT adapted for persons with HF and depressive symptoms can potentially reduce depressive symptoms, cardiac anxiety and increased QoL, but is not statistically superior to participation in an online discussion forum

Background: The aims of this study were to: (I) evaluate the effect of a nine-week guided Internet-based Cognitive Behavioral Therapy (ICBT) program on depressive symptoms (DS) in patients with HF; (II) to assess factors associated with the change in DS; and (III) to investigate the effect of the ICBT program on cardiac anxiety and QoL.

Methods: Fifty participants were included and randomized into two treatment arms: ICBT or an online moderated discussion forum (DF). Data were collected at baseline and at the nine-week follow-up; the Patient Health Questionnaire- nine, (DS); the Cardiac Anxiety Questionnaire, (cardiac-related anxiety); the Minnesota Living with Heart Failure questionnaire, (QoL). Intention to treat analysis was used. Between group differences were determined by analysis of covariance.

Results: In the ICBT-group (n=25), DS improved significantly (P=.02). Also cardiac anxiety in the subscale of fear decreased significantly (P=.04) between baseline and the follow up in the ICBT-group. QoL improved in the ICBT-group by 6 points in the total score and 2.4 points in the physical factor, but this was not significant (P=.09 and P=.12). In the DF-group (n=25) no significant change in the level of DS was found (P=.36). There were no significant differences in the change in DS between the DF- and the ICBT-group (P=.21), nor in cardiac related anxiety (P=.22) or in QoL (total score P=.09, physical factor P=.07). In the ICBT-group, the number of logins to the web-portal correlated significantly with improvement in DS (P=.02), whereas higher age (P=.01) and male sex (P=.048) were associated with less change in DS.

Conclusions: Guided ICBT adapted for persons with HF and DS can potentially reduce DS, cardiac anxiety and increase QoL, but is not statistically superior to participation in an online DF.

This review aims to summarize the theory of cognitive behavioural therapy (CBT) as well as the current evidence for whether CBT can be beneficial for patients with heart failure (HF). Depression and/or anxiety are common in HF patients. However, participation in disease management programmes does not seem to be beneficial for these problems. CBT, which focuses on the identification and changing of dysfunctional beliefs and thoughts and on behaviour therapy, is a possible treatment option. The number of CBT studies on HF is small and they are often not designed as randomized controlled trials. However, the studies on HF indicate that CBT can decrease depression as well as anxiety and suggest that relaxation exercises with elements of CBT may decrease symptom burden. Before implementation in clinical practice, more knowledge is needed about how CBT programmes should be designed, where CBT should be delivered and who should deliver CBT.

Objective: The aim was (1) to describe the development of a guided internet-based CBT (ICBT) program adapted to patients with heart failure (HF) and (2) to evaluate the feasibility of the ICBT program in regard to depressive symptoms, the time used by health care providers to give feedback, and participants perceptions of the ICBT program. Method: A multi-professional team developed the program and seven HF patients with depressive symptoms were recruited to the study. The Patient Health Questionnaire-9 (PHQ-9) and the Montgomery Asberg Depression Rating-Self-rating scale (MADRS-S) were used to measure depression, and patients were interviewed about their perceptions of the program. Results: Based on research in HF and CBT, a nine-week program was developed. The median depression score decreased from baseline to the end of the study (PHQ-9: 11-8.5; MADRS-S: 25.5-16.5) and none of the depression scores worsened. Feedback from health care providers required approximately 3 h per patient. Facilitating perceptions.(e.g. freedom of time) and demanding perceptions (e.g. part of the program demanded a lot of work) were described by the patients. Conclusion: The program appears feasible and time-efficient. However, the program needs to be evaluated in a larger randomized study.

Background: In patients with heart failure (HF) depression is common and is linked to a poor quality of life as well as a poorer prognosis. Despite this less is known about how to treat depression in HF patients.

Aim: The purpose of this study was (I) to design and construct an internet cognitive behavioural therapy (CBT) –program adapted to patients with HF, (II) and in a pilot-study evaluate the feasibility of the program, with respect to its ability to treat depression, time consumption and to identify areas in the need of improvements.

Methods: literature review and expert panel was used to design the program. The feasibility of the program was evaluated in 7 HF patients with depression. Montgomery-Åsberg Depression Rating Scale (MADRS) and Patient Health Questionnaire-9 (PHQ-9) were used to measure depression. Qualitative interviews were conducted to describe the patients perceptions of the program.

Results: The developed 9 week internet CBT program consists of seven modules addressing; introduction, psychoeducation about HF and depression, behavioural activation, problem solving and completion. Before the pilot testing participants mean depression score on MADRS and PHQ-9 was 20 and 11 respectively. After the intervention the mean had decreased to 11.5 and 5.5 respectively. No participants’ depression deteriorated. Time consumption for guidance and feedback was about 20 minutes per participants and week. In interviews pros stated by the participants were: the freedom of time disposition, being able to take the time needed when working with the program and learning about their health problems and what they could do about them. Cons stated were: parts of the program required quiet a lot of reading and work from the participants and some technical problems.

Conclusion: The newly developed 9 week internet CBT-program for patients with HF and depression appears to be feasible and safe.

Background It is unclear how depressive symptoms in patients with heart failure develop

over time and whether this trajectory of depressive symptoms is associated with hospital admission and prognosis.

Aim To describe the time-course of depressive symptoms and determine the relationship with hospital admission and mortality.

Method Data was analysed using 611 patients with completed CES-D questionnaires at baseline and at 18 months. Data on hospital readmission was collected 18 months after discharge and data on mortality was collected 18 and 36 months post-discharge.

Results The prevalence of depressive symptoms was 38% (n=229) at discharge and 26% (n=160) after 18 months. A total of 140 (61%) of the 229 patients with depressive symptoms at discharge had recovered from depressive symptoms after 18 months whereas 71 (18%) of the 382 non-depressed developed depressive symptoms and 89 (39%) of the 229 depressed remained depressed. Depressive symptoms at discharge were not associated with mortality after 18 months but patients with recently (i.e. during 18 months) developed depressive symptoms showed a significantly higher risk for cardiovascular readmissions (HR 1.7, p=0.016). After 36 months, patients with developed depressive symptoms after discharge were at a higher risk of all-cause mortality (HR 2.0, p=0.012) and there was a trend towards a higher risk of all-cause mortality in patients with ongoing depressive symptoms (HR 1.7, p=0.056).

Conclusion A significant proportion of patients with HF, who were reported depressive symptoms at discharge recovered from depressive symptoms during the following 18 months. However, patients who remained having depressive symptoms or patients who developed depressive symptoms had a worse prognosis.