Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia:A Randomized Waitlist Controlled Trial

Background: This study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have insomnia. Objective: The objective of our study was to investigate the efficacy of CBT-I delivered via the Sleepcare mobile phone app, compared with a waitlist control group, in a randomized controlled trial. Methods: We recruited participants in the Netherlands with relatively mild insomnia disorder. After answering an online pretest questionnaire, they were randomly assigned to the app (n=74) or the waitlist condition (n=77). The app packaged a sleep diary, a relaxation exercise, sleep restriction exercise, and sleep hygiene and education. The app was fully automated and adjusted itself to a participant’s progress. Program duration was 6 to 7 weeks, after which participants received posttest measurements and a 3-month follow-up. The participants in the waitlist condition received the app after they completed the posttest questionnaire. The measurements consisted of questionnaires and 7-day online diaries. The questionnaires measured insomnia severity, dysfunctional beliefs about sleep, and anxiety and depression symptoms. The diary measured sleep variables such as sleep efficiency. We performed multilevel analyses to study the interaction effects between time and condition. Results: The results showed significant interaction effects (P<.01) favoring the app condition on the primary outcome measures of insomnia severity (d=–0.66) and sleep efficiency (d=0.71). Overall, these improvements were also retained in a 3-month follow-up. Conclusions: This study demonstrated the efficacy of a fully automated mobile phone app in the treatment of relatively mild insomnia. The effects were in the range of what is found for Web-based treatment in general. This supports the applicability of such technical tools in the treatment of insomnia. Future work should examine the generalizability to a more diverse population. Furthermore, the separate components of such an app should be investigated. It remains to be seen how this app can best be integrated into the current health regimens. Trial Registration: Netherlands Trial Register: NTR5560; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5560 (Archived by WebCite at http://www.webcitation.org/6noLaUdJ4

Digital health technologies in the psychosocial treatment of core symptoms of psychotic disorders - literature review and practical aspects

Peer reviewe

A Systematic Review and Meta-Analysis of Self-Guided Online Acceptance and Commitment Therapy as a Transdiagnostic Self-Help Intervention

Online Acceptance and Commitment Therapy (ACT) interventions use websites and smartphone apps to deliver ACT exercises and skills. The present meta-analysis provides a comprehensive review of online ACT self-help interventions, characterizing the programs that have been studied (e.g. platform, length, content) and analyzing their efficacy. A transdiagnostic approach was taken, including studies that addressed a range of targeted problems and populations. Multi-level meta-analyses were used to nest multiple measures of a single construct within their respective studies. A total of 53 randomized controlled trials were included (n = 10,730). Online ACT produced significantly greater outcomes than waitlist controls at post-treatment for anxiety, depression, quality of life, psychological flexibility, and all assessed outcomes (i.e. omnibus effect), which were generally maintained at follow-up. However, only psychological flexibility and all assessed outcomes at post-treatment were found to be significantly greater for online ACT when compared to active controls, with no significant follow-up effects. Overall, these results further clarify that ACT can be effectively delivered in an online format to target a wide range of mental health concerns, although it is less clear if and when online ACT is more efficacious than other online interventions

Individually tailored internet-based treatment for depression and comorbid conditions

Background: Depression is a large societal problem. People suffering from depression are heterogeneous and have a high degree of comorbid conditions. Pharmacological treatment is widespread, but not effective for all sufferers, and patients often have a preference for psychological treatment. There are effective psychological treatment alternatives, but access to treatment is low. Individually tailored internet-based treatment has the ability to target several conditions within the same treatment. It has shown promising effects on depression and anxiety but needs to be further evaluated against other interventions. The effects of specific treatment components also need to be explored. Aims: The aims of this thesis were to evaluate the effects and cost-effectiveness of individually tailored internet-based treatment compared to other treatment alternatives, to compare its effects to disorder-specific benchmark treatments, and to explore if compliance to treatment components for specific conditions predict reductions in the targeted symptoms. Methods: Study I-IV were based on the randomized trial REGASSA (n = 946) where an individually tailored internet-based treatment (TAIL) were compared to structured physical exercise (PE) and to treatment as usual in primary care (TAU). In Study I, the effects of TAIL and PE on depression symptoms were evaluated against TAU. Study II evaluated the cost- effectiveness of TAIL and PE against TAU. In Study III, TAIL was compared to similar, but disorder-specific, benchmark treatments for depression (n = 2358), panic disorder (n = 1176) and social anxiety disorder (n = 1335). In Study IV, the participants’ compliance to the different specific components in the TAIL-intervention were rated, and related to symptom reductions. Results: The effects of TAIL on depression symptoms were large (g = 1.47, 95% CI 1.29- 1.66), and there were significantly larger reductions in depression symptoms than in the TAU- group. There were no significant differences in effects on depression symptoms between TAIL and PE. TAIL and PE had 90 and 76 % probabilities respectively, of being cost-effective compared to TAU, given standard health care provider willingness to pay-thresholds. The effects of TAIL on depression symptoms were non-inferior to disorder-specific internet-based treatment. The effects of TAIL on panic or social anxiety symptoms however, could not be concluded to be non-inferior to disorder-specific treatment. Overall compliance with TAIL was strongly related to symptom reductions in depression, panic, social anxiety, stress and insomnia, weakly related to reductions in worry, but not related to reductions in pain symptoms. Compliance to specific components for social anxiety was related to reductions in specific social anxiety symptoms. Compliance to specific components for stress and insomnia were particularly important since they were related to both specific symptom reductions and reductions of depressive symptoms. Conclusions: The results in this thesis support that individually tailored internet-based treatment is an effective and cost-effective treatment alternative to be considered for implementation. It is as effective as the disorder-specific internet-based treatments for depression already used in routine care, but more comparisons are needed to conclude if it is as effective as disorder-specific anxiety treatments. Since specific treatment components for stress and insomnia were important for both specific and depressive symptom reductions, it is probable that individual tailoring for these conditions is worthwhile in the treatment of depression

Clinical guidelines for the use of lifestyle-based mental health care in major depressive disorder: World Federation of Societies for Biological Psychiatry (WFSBP) and Australasian Society of Lifestyle Medicine (ASLM) taskforce

Objectives: The primary objectives of these international guidelines were to provide a global audience of clinicians with (a) a series of evidence-based recommendations for the provision of lifestyle-based mental health care in clinical practice for adults with Major Depressive Disorder (MDD) and (b) a series of implementation considerations that may be applicable across a range of settings. Methods: Recommendations and associated evidence-based gradings were based on a series of systematic literature searches of published research as well as the clinical expertise of taskforce members. The focus of the guidelines was eight lifestyle domains: physical activity and exercise, smoking cessation, work-directed interventions, mindfulness-based and stress management therapies, diet, sleep, loneliness and social support, and green space interaction. The following electronic bibliographic databases were searched for articles published prior to June 2020: PubMed, EMBASE, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Methodology Register), CINAHL, PsycINFO. Evidence grading was based on the level of evidence specific to MDD and risk of bias, in accordance with the World Federation of Societies for Biological Psychiatry criteria. Results: Nine recommendations were formed. The recommendations with the highest ratings to improve MDD were the use of physical activity and exercise, relaxation techniques, work-directed interventions, sleep, and mindfulness-based therapies (Grade 2). Interventions related to diet and green space were recommended, but with a lower strength of evidence (Grade 3). Recommendations regarding smoking cessation and loneliness and social support were based on expert opinion. Key implementation considerations included the need for input from allied health professionals and support networks to implement this type of approach, the importance of partnering such recommendations with behaviour change support, and the need to deliver interventions using a biopsychosocial-cultural framework. Conclusions: Lifestyle-based interventions are recommended as a foundational component of mental health care in clinical practice for adults with Major Depressive Disorder, where other evidence-based therapies can be added or used in combination. The findings and recommendations of these guidelines support the need for further research to address existing gaps in efficacy and implementation research, especially for emerging lifestyle-based approaches (e.g. green space, loneliness and social support interventions) where data are limited. Further work is also needed to develop innovative approaches for delivery and models of care, and to support the training of health professionals regarding lifestyle-based mental health care

Effects of a Web-Based Intervention for Stress Reduction in Primary Care: A Cluster Randomized Controlled Trial

Background: Preliminary findings suggest that Web-based interventions may be effective in achieving significant stress reduction. To date, there are no findings available for primary care patients. This is the first study that investigates a Web-based intervention for stress reduction in primary care. Objective: The aim was to examine the short-term effectiveness of a fully automated Web-based coaching program regarding stress reduction in a primary care setting. Methods: The study was an unblinded cluster randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily text message reminders, and weekly feedback through the Internet. All components of the program were fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was change in the Perceived Stress Questionnaire (PSQ) over 12 weeks. Results: A total of 93 participants (40 in intervention group, 53 in control group) were recruited into the study. For 25 participants from the intervention group and 49 participants from the control group, PSQ scores at baseline and 12 weeks were available. In the intention-to-treat analysis, the PSQ score decreased by mean 8.2 (SD 12.7) in the intervention group and by mean 12.6 (SD 14.7) in the control group. There was no significant difference identified between the groups (mean difference -4.5, 95% CI -10.2 to 1.3, P=. 13). Conclusions: This trial could not show that the tested Web-based intervention was effective for reducing stress compared to usual care. The limited statistical power and the high dropout rate may have reduced the study's ability to detect significant differences between the groups. Further randomized controlled trials are needed with larger populations to investigate the long-term outcome as well as the contents of usual primary care

How should a virtual agent present psychoeducation?

BACKGROUND AND OBJECTIVE: With the rise of autonomous e-mental health applications, virtual agents can play a major role in improving trustworthiness, therapy outcome and adherence. In these applications, it is important that patients adhere in the sense that they perform the tasks, but also that they adhere to the specific recommendations on how to do them well. One important construct in improving adherence is psychoeducation, information on the why and how of therapeutic interventions. In an e-mental health context, this can be delivered in two different ways: verbally by a (virtual) embodied conversational agent or just via text on the scree