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BACKGROUND: Insomnia is a highly prevalent disorder associated with numerous adverse health outcomes. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment by clinical guidelines but is accessible to only a minority of patients suffering from insomnia. Internet-delivered CBT-I (iCBT-I) could contribute to the widespread dissemination of this first-line treatment. As there is insufficient evidence regarding non-inferiority, this study directly aims to compare therapist-guided internet-delivered versus face-to-face CBT-I in terms of insomnia severity post-treatment. Furthermore, a health-economic evaluation will be conducted, and potential benefits and disadvantages of therapist-guided iCBT-I will be examined.METHODS: This study protocol describes a randomised controlled two-arm parallel-group non-inferiority trial comparing therapist-guided iCBT-I with face-to-face CBT-I in routine clinical care. A total of 422 patients with insomnia disorder will be randomised and treated at 16 study centres throughout Germany. Outcomes will be assessed at baseline, 10 weeks after randomisation (post), and 6 months after randomisation (follow-up). The primary outcome is insomnia severity measured using the Insomnia Severity Index. Secondary outcomes include depression-related symptoms, quality of life, fatigue, physical activity, daylight exposure, adverse events related to treatment, and a health-economic evaluation. Finally, potential moderator variables and several descriptive and exploratory outcomes will be assessed (e.g. benefits and disadvantages of internet-delivered treatment).DISCUSSION: The widespread implementation of CBT-I is a significant healthcare challenge. The non-inferiority of therapist-guided iCBT-I versus face-to-face CBT-I will be investigated in an adequately powered sample in routine clinical care, with the same therapeutic content and same level of therapist qualifications provided with both interventions

There is an unmet need for effective early interventions that can relieve initial trauma symptoms and reduce symptoms of posttraumatic stress disorder (PTSD). We evaluated the efficacy of cognitive interventions compared to control in reducing intrusion frequency and PTSD symptoms in healthy individuals using the trauma film paradigm, in which participants view a film with aversive content as an experimental analogue of trauma exposure. A systematic literature search identified 41 experiments of different cognitive interventions targeting intrusions. In the meta-analysis, the pooled effect size of 52 comparisons comparing cognitive interventions to no-intervention controls on intrusions was moderate (g = −0.46, 95% CI [–0.61 to −0.32], p < .001). The pooled effect size of 16 comparisons on PTSD symptoms was also moderate (g = −0.31, 95% CI [–0.46 to −0.17], p < .001). Both visuospatial interference and imagery rescripting tasks were associated with significantly fewer intrusions than controls, whereas verbal interference and meta-cognitive processing tasks showed nonsignificant effect sizes. Interventions administered after viewing the trauma film showed significantly fewer intrusions than controls, whereas interventions administered during film viewing did not. No experiments had low risk of bias (ROB), 37 experiments had some concerns of ROB, while the remaining four experiments had high ROB. To the best of our knowledge, this is the first meta-analysis investigating the efficacy of cognitive interventions targeting intrusions in non-clinical samples. Results seem to be in favour of visuospatial interference tasks rather than verbal tasks. More research is needed to develop an evidence base on the efficacy of various cognitive interventions and test their clinical translation to reduce intrusive memories of real trauma.

Transdiagnostic individually-tailored digital interventions reduce symptoms of depression and anxiety in adults with moderate effects. However, research into these approaches for college students is scarce and contradicting. In addition, the exact reasons for intervention dropout in this target group are not well known, and the use of individually-tailored intervention features, such as optional modules, has not yet been explored. The current study aimed to (1) investigate reasons for dropout from a guided internet-based transdiagnostic individually-tailored intervention for college students assessed in a randomized controlled trial (RCT) and (2) evaluate whether participants used tailoring features intended for their baseline symptoms. A sample of college students with mild to moderate depression and/or anxiety symptoms (n = 48) in the Netherlands (partially) followed a guided internet-based transdiagnostic individually-tailored intervention. We contacted those who did not complete the entire intervention (n = 29) by phone to report the reasons for intervention dropout. Further, we descriptively explored the use of tailoring features (i.e., depression versus anxiety trajectory) and optional modules of the intervention in the whole sample. We identified a range of person- and intervention-related reasons for intervention dropout, most commonly busy schedules, needs for different kinds of help, or absence of personal contact. Furthermore, only less than half of the participants used the individually-tailoring features to address the symptoms they reported as predominant. In conclusion, digital interventions clear about the content and targeted symptoms, tested in user research could prevent dropout and create reasonable expectations of the intervention. Participants would benefit from additional guidance when using tailoring features of digital interventions, as they often do not choose the tailoring features targeting their baseline symptoms.

Background The establishment of a valuable and meaningful working alliance between people with mild intellectual disabilities (IDs) and healthcare professionals is critically important for improving both the quality of life and impact of therapy for people with mild IDs. Measuring the working alliance as a treatment or support component is therefore of utmost relevance. In light of the increased use of eHealth tools, it is also essential to measure the alliance using these tools, which is referred to as technical alliance. There was a lack of validation of these two measurements for healthcare professionals working with people with mild IDs, which this study sought to address. Method Both the validated Working Alliance Inventory – Short Form – MID (WAI-SF-MID) and Technical Alliance Inventory – Short Form – MID (TAI-SF-MID) for general patient populations were adapted for healthcare professionals working with people with mild IDs. A two-step approach was conducted to systematically adapt both measurements with an expert group of healthcare professionals. Confirmatory factor analysis was conducted to test a three-factor structure for both the WAI-SF-MID (N = 199) and the TAI-SF-MID (N = 139), and internal consistency was determined for both scales. Results An acceptable-to-good model fit was found for both the WAI-SF-MID and the TAI-SF-MID; confirmatory factor analysis confirmed a three-factor model for both measurements. Cronbach's alpha and McDonald's omega were excellent for both total scales (≥0.90) and acceptable to good for sub-scales of both versions. Conclusion Both the WAI-SF-MID and the TAI-SF-MID are promising measurements for determining healthcare professionals' perspective on the (digital) working alliance with people with mild IDs.

Contains fulltext : 285363.pdf (Publisher’s version ) (Open Access), In 2015, Apple launched an open-source software framework called ResearchKit. ResearchKit provides an infrastructure for conducting remote, smartphone-based research trials through the means of Apple's App Store. Such trials may have several advantages over conventional trial methods including the removal of geographic barriers, frequent assessments of participants in real-life settings, and increased inclusion of seldom-heard communities. The aim of the current study was to explore the feasibility of participant recruitment and the potential for data collection in the non-clinical population in a smartphone-based trial using ResearchKit. As a case example, an app called eMovit, a behavioural activation (BA) app with the aim of helping users to build healthy habits was used. The study was conducted over a 9-month period. Any iPhone user with access to the App Stores of The Netherlands, Belgium, and Germany could download the app and participate in the study. During the study period, the eMovit app was disseminated amongst potential users via social media posts (Twitter, Facebook, LinkedIn), paid social media advertisements (Facebook), digital newsletters and newspaper articles, blogposts and other websites. In total, 1,788 individuals visited the eMovit landing page. A total of 144 visitors subsequently entered Apple's App Store through that landing page. The eMovit product page was viewed 10,327 times on the App Store. With 79 installs, eMovit showed a conversion rate of 0.76% from product view to install of the app. Of those 79 installs, 53 users indicated that they were interested to participate in the research study and 36 subsequently consented and completed the demographics and the participants quiz. Fifteen participants completed the first PHQ-8 assessment and one participant completed the second PHQ-8 assessment. We conclude that from a technological point of view, the means provided by ResearchKit are well suited to be integrated into the app process and th

Introduction Emerging adulthood is a phase in life that is associated with an increased risk to develop a variety of mental health disorders including anxiety and depression. However, less than 25% of university students receive professional help for their mental health reports. Internet-based cognitive behavioural therapy (iCBT) may entail useful interventions in a format that is attractive for university students. The aim of this study protocol is to test the effectiveness of a therapist-guided versus a computer-guided transdiagnostic iCBT programme with a main focus on anxiety and depression. Methods and analysis University students with anxiety and/or depressive symptoms will be randomised to a (1) 7-week iCBT programme (excluding booster session) with therapist feedback, (2) the identical iCBT programme with computer feedback only or (3) care as usual. Participants in the care as usual condition are informed and referred to conventional care services and encouraged to seek the help they need. Primary outcome variables are self-reported levels of anxiety as measured with the General Anxiety Disorder-7 and self-reported levels of depression as measured with the Patient Health Questionnaire-9. Secondary outcomes include treatment adherence, client satisfaction, medical service use, substance use, quality of life and academic achievement. Assessments will take place at baseline (t1), midtreatment (t2), post-treatment (t3), at 6 months (t4) and 12 months (t5) postbaseline. Social anxiety and perfectionism are included as potentially important predictors of treatment outcome. Power calculations are based on a 3 (group) × 3 (measurement: pretreatment, midtreatment and post-treatment) interaction, resulting in an aimed sample of 276 participants. Data will be analysed based on intention-to-treat and per protocol samples using mixed linear models.

Contains fulltext : 234365.pdf (Publisher’s version ) (Open Access), Depression is a major problem in youth mental health. Current treatment is on average effective, but adolescents are hesitant to seek help. Blended treatment could lower the barriers to seeking treatment. Evidence on effectiveness is, however, scarce. The present pragmatic quasi-experimental controlled trial aimed to compare the outcomes of blended cognitive behavioral therapy (CBT) to face-to-face CBT and treatment as usual. A total of 129 adolescents with clinical depression (82.2% female), aged 13-22 (M = 16.60, SD = 2.03) received blended CBT, face-to-face CBT or treatment as usual. Clinical diagnosis, depressive symptoms, and secondary outcomes were assessed at baseline, post-intervention, and six-months follow-up. Participants receiving blended CBT were, compared to participants receiving face-to-face CBT and treatment as usual, evenly likely to be in remission from their depressive disorder at post-intervention and at six-month follow-up. Depressive symptoms decreased significantly over time in all three conditions, and changes were not significantly different between conditions. Other secondary outcomes (suicide risk, internalizing and externalizing symptoms, severity of depression, and global functioning) did not differ between treatment conditions at post-intervention and six-month follow-up. Since there was no evidence for favorable outcomes for face-to-face therapies above blended CBT, blended CBT may also be an effective treatment format in clinical practice.

Contains fulltext : 241606.pdf (Publisher’s version ) (Open Access), Background: Poor treatment adherence in patients with chronic obstructive pulmonary disease (COPD) or asthma is a global public health concern with severe consequences in terms of patient health and societal costs. A potentially promising tool for addressing poor compliance is eHealth. Objective: This review investigates the effects of eHealth interventions on medication adherence in patients with COPD or asthma. Methods: A systematic literature search was conducted in the databases of Cochrane Library, PsycINFO, PubMed, and Embase for studies with publication dates between January 1, 2000, and October 29, 2020. We selected randomized controlled trials targeting adult patients with COPD or asthma, which evaluated the effectiveness of an eHealth intervention on medication adherence. The risk of bias in the included studies was examined using the Cochrane Collaboration’s risk of bias tool. The results were narratively reviewed. Results: In total, six studies focusing on COPD and seven focusing on asthma were analyzed. Interventions were mostly internet-based or telephone-based, and could entail telemonitoring of symptoms and medication adherence, education, counseling, consultations, and self-support modules. Control groups mostly comprised usual care conditions, whereas a small number of studies used a face-to-face intervention or waiting list as the control condition. For COPD, the majority of eHealth interventions were investigated as an add-on to usual care (5/6 studies), whereas for asthma the majority of interventions were investigated as a standalone intervention (5/7 studies). Regarding eHealth interventions targeting medication adherence for COPD, two studies reported nonsignificant effects, one study found a significant effect in comparison to usual care, and three reported mixed results. Of the seven studies that investigated eHealth interventions targeting medication adherence in asthma, three studies found significant effects, two reported nonsignificant

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 reduc

IMPORTANCE: Personalized treatment choices would increase the effectiveness of internet-based cognitive behavioral therapy (iCBT) for depression to the extent that patients differ in interventions that better suit them. OBJECTIVE: To provide personalized estimates of short-term and long-term relative efficacy of guided and unguided iCBT for depression using patient-level information. DATA SOURCES: We searched PubMed, Embase, PsycInfo, and Cochrane Library to identify randomized clinical trials (RCTs) published up to January 1, 2019. STUDY SELECTION: Eligible RCTs were those comparing guided or unguided iCBT against each other or against any control intervention in individuals with depression. Available individual patient data (IPD) was collected from all eligible studies. Depression symptom severity was assessed after treatment, 6 months, and 12 months after randomization. DATA EXTRACTION AND SYNTHESIS: We conducted a systematic review and IPD network meta-analysis and estimated relative treatment effect sizes across different patient characteristics through IPD network meta-regression. MAIN OUTCOMES AND MEASURES: Patient Health Questionnaire-9 (PHQ-9) scores. RESULTS: Of 42 eligible RCTs, 39 studies comprising 9751 participants with depression contributed IPD to the IPD network meta-analysis, of which 8107 IPD were synthesized. Overall, both guided and unguided iCBT were associated with more effectiveness as measured by PHQ-9 scores than control treatments over the short term and the long term. Guided iCBT was associated with more effectiveness than unguided iCBT (mean difference [MD] in posttreatment PHQ-9 scores, -0.8; 95% CI, -1.4 to -0.2), but we found no evidence of a difference at 6 or 12 months following randomization. Baseline depression was found to be the most important modifier of the relative association for efficacy of guided vs unguided iCBT. Differences between unguided and guided iCBT in people with baseline symptoms of subthreshold depression (PHQ

Contains fulltext : 226696.pdf (publisher's version ) (Open Access), Background: Poor adherence to continuous positive airway pressure (CPAP) treatment by adults with obstructive sleep apnea (OSA) is a common issue. Strategies delivered by means of information and communication technologies (ie, eHealth) can address treatment adherence through patient education, real-time monitoring of apnea symptoms and CPAP adherence in daily life, self-management, and early identification and subsequent intervention when device or treatment problems arise. However, the effectiveness of available eHealth technologies in improving CPAP adherence has not yet been systematically studied. Objective: This meta-analytic review was designed to investigate the effectiveness of a broad range of eHealth interventions in improving CPAP treatment adherence. Methods: We conducted a systematic literature search of the databases of Cochrane Library, PsycINFO, PubMed, and Embase to identify relevant randomized controlled trials in adult OSA populations. The risk of bias in included studies was examined using seven items of the Cochrane Collaboration risk-of-bias tool. The meta-analysis was conducted with comprehensive meta-analysis software that computed differences in mean postintervention adherence (MD), which was defined as the average number of nightly hours of CPAP use. Results: The meta-analysis ultimately included 18 studies (N=5429 adults with OSA) comprising 22 comparisons between experimental and control conditions. Postintervention data were assessed at 1 to 6 months after baseline, depending on the length of the experimental intervention. eHealth interventions increased the average nightly use of CPAP in hours as compared with care as usual (MD=0.54, 95% CI 0.29-0.79). Subgroup analyses did not reveal significant differences in effects between studies that used eHealth as an add-on or as a replacement to care as usual (P=.95), between studies that assessed stand-alone eHealth and blended strategies combining eHealth with face-to-face care (P=.23), or b

Contains fulltext : 225770.pdf (publisher's version ) (Open Access), Background: Internet-based cognitive-behavioral therapy (iCBT) is more effective when it is guided by human support than when it is unguided. This may be attributable to higher adherence rates that result from a positive effect of the accompanying support on motivation and on engagement with the intervention. This protocol presents the design of a pilot randomized controlled trial that aims to start bridging the gap between guided and unguided interventions. It will test an intervention that includes automated support delivered by an embodied conversational agent (ECA) in the form of a virtual coach. Methods/design: The study will employ a pilot two-armed randomized controlled trial design. The primary outcomes of the trial will be (1) the effectiveness of iCBT, as supported by a virtual coach, in terms of improved intervention adherence in comparison with unguided iCBT, and (2) the feasibility of a future, larger-scale trial in terms of recruitment, acceptability, and sample size calculation. Secondary aims will be to assess the virtual coach's effect on motivation, users’ perceptions of the virtual coach, and general feasibility of the intervention as supported by a virtual coach. We will recruit N = 70 participants from the general population who wish to learn how they can improve their mood by using Moodbuster Lite, a 4-week cognitive-behavioral therapy course. Candidates with symptoms of moderate to severe depression will be excluded from study participation. Included participants will be randomized in a 1:1 ratio to either (1) Moodbuster Lite with automated support delivered by a virtual coach or (2) Moodbuster Lite without automated support. Assessments will be taken at baseline and post-study 4 weeks later. Discussion: The study will assess the preliminary effectiveness of a virtual coach in improving adherence and will determine the feasibility of a larger-scale RCT. It could represent a significant step in bridging the gap between guided and unguided iCBT

Background: Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union’s Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities. Methods: A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study. Discussion: The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT ser

Introduction Psychotherapy may reduce suicidal thoughts and behaviour, but its effectiveness is not well examined. Furthermore, conventional meta-analyses are unable to test possible effects of moderators affecting this relationship. This protocol outlines the building of a comprehensive database of the literature in this research field. In addition, we will conduct an individual patient data meta-analysis (IPD-MA) to establish the effectiveness of psychotherapy in reducing suicidality, and to examine which factors moderate the efficacy of these interventions. Methods and analysis To build a comprehensive database, randomised controlled trials examining the effect of any psychotherapy targeting any psychiatric disorder on suicidal thoughts or behaviour will be identified by running a systematic search in PubMed, Embase, PsycINFO, Web of Science, Scopus and The Cochrane Central Register of Controlled Trials from data inception to 12 August 2019. For the IPD-MA, we will focus on adult outpatients with suicidal ideation or behaviour. In addition, as a comparison group we will focus on a control group (waiting-list, care as usual or placebo). A 1-stage IPD-MA will be used to determine the effectiveness of psychotherapy on suicidal ideation, suicide attempts and/or suicide deaths, and to investigate potential patient-related and intervention-related moderators. Subgroup and sensitivity analyses will be conducted to test the robustness of the findings. Additionally, a conventional MA will be conducted to determine the differences between studies that provided IPD and those that did not. IPD-MA may determine the effectiveness of psychotherapy in reducing suicidality and provide insights into the moderating factors influencing the efficacy of psychotherapy. Answering these questions will inform mental healthcare practitioners about optimal treatments for different groups of individuals with suicidal ideation and/or behaviour and consequently help to reduce suicide risk. Eth

The European Union (EU) initiative on the Digital Transformation of Health and Care (Digicare) aims to provide the conditions necessary for building a secure, flexible, and decentralized digital health infrastructure. Creating a European Health Research and Innovation Cloud (HRIC) within this environment should enable data sharing and analysis for health research across the EU, in compliance with data protection legislation while preserving the full trust of the participants. Such a HRIC should learn from and build on existing data infrastructures, integrate best practices, and focus on the concrete needs of the community in terms of technologies, governance, management, regulation, and ethics requirements. Here, we describe the vision and expected benefits of digital data sharing in health research activities and present a roadmap that fosters the opportunities while answering the challenges of implementing a HRIC. For this, we put forward five specific recommendations and action points to ensure that a European HRIC: i) is built on established standards and guidelines, providing cloud technologies through an open and decentralized infrastructure; ii) is developed and certified to the highest standards of interoperability and data security that can be trusted by all stakeholders; iii) is supported by a robust ethical and legal framework that is compliant with the EU General Data Protection Regulation (GDPR); iv) establishes a proper environment for the training of new generations of data and medical scientists; and v) stimulates research and innovation in transnational collaborations through public and private initiatives and partnerships funded by the EU through Horizon 2020 and Horizon Europe.