Implementation of Internet-based preventive interventions for depression and anxiety: role of support? The design of a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Internet-based self-help is an effective preventive intervention for highly prevalent disorders, such as depression and anxiety. It is not clear, however, whether it is necessary to offer these interventions with professional support or if they work without any guidance. In case support is necessary, it is not clear which level of support is needed. This study examines whether an internet-based self-help intervention with a coach is more effective than the same intervention without a coach in terms of clinical outcomes, drop-out and economic costs. Moreover, we will investigate which level of support by a coach is more effective compared to other levels of support.</p> <p>Methods</p> <p>In this randomized controlled trial, a total of 500 subjects (18 year and older) from the general population with mild to moderate depression and/or anxiety will be assigned to one of five conditions: (1) web-based problem solving through the internet (self-examination therapy) without a coach; (2) the same as 1, but with the possibility to ask help from a coach on the initiative of the respondent (on demand, by email); (3) the same as 1, but with weekly scheduled contacts initiated by a coach (once per week, by email); (4) weekly scheduled contacts initiated by a coach, but no web-based intervention; (5) information only (through the internet). The interventions will consist of five weekly lessons. Primary outcome measures are symptoms of depression and anxiety. Secondary outcome measures are drop-out from the intervention, quality of life, and economic costs. Other secondary outcome measures that may predict outcome are also studied, e.g. client satisfaction and problem-solving skills. Measures are taken at baseline (pre-test), directly after the intervention (post-test, five weeks after baseline), 3 months later, and 12 months later. Analysis will be conducted on the intention-to-treat sample.</p> <p>Discussion</p> <p>This study aims to provide more insight into the clinical effectiveness, differences in drop-out rate and costs between interventions with and without support, and in particular different levels of support. This is important to know in relation to the dissemination of internet-based self-help interventions.</p> <p>Trial Registration</p> <p>Nederlands Trial Register (NTR): TC1355</p

Design of a multicentered randomized controlled trial on the clinical and cost effectiveness of schema therapy for personality disorders

<p>Abstract</p> <p>Background</p> <p>Despite international guidelines describing psychotherapy as first choice for people with personality disorders (PDs), well-designed research on the effectiveness and cost-effectiveness of psychotherapy for PD is scarce. Schema therapy (ST) is a specific form of psychological treatment that proved to be effective for borderline PD. Randomized controlled studies on the effectiveness of ST for other PDs are lacking. Another not yet tested new specialized treatment is Clarification Oriented Psychotherapy (COP). The aim of this project is to perform an effectiveness study as well as an economic evaluation study (cost effectiveness as well as cost-utility) comparing ST versus COP versus treatment as usual (TAU). In this study, we focus on avoidant, dependent, obsessive-compulsive, paranoid, histrionic and narcissistic PD.</p> <p>Methods/Design</p> <p>In a multicentered randomized controlled trial, ST, and COP as an extra experimental condition, are compared to TAU. Minimal 300 patients are recruited in 12 mental health institutes throughout the Netherlands, and receive an extensive screening prior to enrolment in the study. When eligible, they are randomly assigned to one of the intervention groups. An economic evaluation and a qualitative research study on patient and therapist perspectives on ST are embedded in this trial. Outcome assessments (both for clinical effectiveness and economic evaluation) take place at 6,12,18,24 and 36 months after start of treatment. Primary outcome is recovery from PD; secondary measures include general psychopathological complaints, social functioning and quality of life. Data for the cost-effectiveness and cost-utility analyses are collected by using a retrospective cost interview. Information on patient and therapist perspectives is gathered using in-depth interviews and focus groups, and focuses on possible helpful and impeding aspects of ST.</p> <p>Discussion</p> <p>This trial is the first to compare ST and COP head-to-head with TAU for people with a cluster C, paranoid, histrionic and/or narcissistic PD. By combining clinical effectiveness data with an economic evaluation and with direct information from primary stakeholders, this trial offers a complete and thorough view on ST as a contribution to the improvement of treatment for this PD patient group.</p> <p>Trial registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=566">NTR566</a></p

D-cycloserine augmentation of exposure-based cognitive behavior therapy for anxiety, obsessive-compulsive, and posttraumatic stress disorders: A systematic review and meta-analysis of individual participant data

Contains fulltext : 174490.pdf (publisher's version ) (Open Access)Importance: Whether and under which conditions D-cycloserine (DCS) augments the effects of exposure-based cognitive behavior therapy for anxiety, obsessive-compulsive, and posttraumatic stress disorders is unclear. Objective: To clarify whether DCS is superior to placebo in augmenting the effects of cognitive behavior therapy for anxiety, obsessive-compulsive, and posttraumatic stress disorders and to evaluate whether antidepressants interact with DCS and the effect of potential moderating variables. Data Sources: PubMed, EMBASE, and PsycINFO were searched from inception to February 10, 2016. Reference lists of previous reviews and meta-analyses and reports of randomized clinical trials were also checked. Study Selection: Studies were eligible for inclusion if they were (1) double-blind randomized clinical trials of DCS as an augmentation strategy for exposure-based cognitive behavior therapy and (2) conducted in humans diagnosed as having specific phobia, social anxiety disorder, panic disorder with or without agoraphobia, obsessive-compulsive disorder, or posttraumatic stress disorder. Data Extraction and Synthesis: Raw data were obtained from the authors and quality controlled. Data were ranked to ensure a consistent metric across studies (score range, 0-100). We used a 3-level multilevel model nesting repeated measures of outcomes within participants, who were nested within studies. Results: Individual participant data were obtained for 21 of 22 eligible trials, representing 1047 of 1073 eligible participants. When controlling for antidepressant use, participants receiving DCS showed greater improvement from pretreatment to posttreatment (mean difference, -3.62; 95% CI, -0.81 to -6.43; P = .01; d = -0.25) but not from pretreatment to midtreatment (mean difference, -1.66; 95% CI, -4.92 to 1.60; P = .32; d = -0.14) or from pretreatment to follow-up (mean difference, -2.98, 95% CI, -5.99 to 0.03; P = .05; d = -0.19). Additional analyses showed that participants assigned to DCS were associated with lower symptom severity than those assigned to placebo at posttreatment and at follow-up. Antidepressants did not moderate the effects of DCS. None of the prespecified patient-level or study-level moderators was associated with outcomes. Conclusions and Relevance: D-cycloserine is associated with a small augmentation effect on exposure-based therapy. This effect is not moderated by the concurrent use of antidepressants. Further research is needed to identify patient and/or therapy characteristics associated with DCS response.10 p

A Pilot Digital Intervention Targeting Loneliness in Youth Mental Health

Background: Loneliness is an emerging issue for young people, but yet many interventions to address loneliness in this group focus on providing social opportunities. While these sorts of interventions may appear to increase social connections, loneliness is more related to quality rather than quantity of social relationships. Thus, interventions addressing loneliness should focus on maximizing the quality of current relationships. Together with youth consumers both with mental ill health and those without, we developed a digital smartphone application (app) called +Connect. The 6-week program delivers positive psychology content designed to improve relationship quality. We tested the acceptability, feasibility, and safety of the program in lonely young people with or without a mental health diagnosis of social anxiety disorder. We used a mixed method study design to triangulate pilot quantitative and qualitative data in young people with and without social anxiety disorder (SAD). Method: Nine participants with a diagnosis of social anxiety disorder (Mage = 21.00; SD = 1.41) and 11 participants with no mental health conditions (Mage = 20.36; SD = 2.16) completed the +Connect digital intervention. Results: Those with social anxiety disorder reported less acceptable ratings on outcomes. Feasibility ratings, measured by uptake and app completion, met a priori threshold criteria in both groups. Those with social anxiety disorder yielded more attrition, with almost double the attrition rate compared with those without the disorder. There were no safety issues elicited during the pilot study. In terms of outcomes, exploratory analyses indicated that the app itself is likely to be beneficial rather than cause harm. Our qualitative data indicated both groups reported no negative outcomes and noted that positive outcomes were driven by three processes: reflection, learning, and real-life application. Further exploratory data on usability indicated room for improvement in terms of giving more support for different components of the app (i.e., challenges). Conclusion: The pilot findings of this proof-of-concept app indicates some promise in terms of a second iterative version of +Connect

A pilot randomised controlled trial of the Peer Tree digital intervention targeting loneliness in young people: a study protocol

Background: Young people are vulnerable to experiencing problematic levels of loneliness which can lead to poor mental health outcomes. Loneliness is a malleable treatment target and preliminary evidence has shown that it can be addressed with digital platforms. Peer Tree is a strength-based digital smartphone application aimed at reducing loneliness. The study aim is to reduce loneliness and assess the acceptability, usability, and feasibility of Peer Tree in young people enrolled at university. Methods: This will be a pilot randomised controlled trial (RCT) comparing a strength-based digital smartphone application (Peer Tree) with a control condition. Forty-two young people enrolled at university will be recruited for this pilot RCT. Participants with suicidal ideation or behaviours, acute psychiatric symptoms in the past month, or a current diagnosis of a mood or social anxiety disorder will be excluded. Allocation will be made on a 1:1 ratio and will occur after the initial baseline assessment. Assessments are completed at baseline, at post-intervention, and at follow-up. Participants in the control condition complete the same three assessment sessions. The primary outcome of the study will be loneliness. Depression, social anxiety, quality of life, acceptability, usability, feasibility, and safety of Peer Tree will also be measured as secondary outcomes. Discussion: This trial will report the findings of implementing Peer Tree, a smartphone application aimed at reducing loneliness in university students. Findings from this trial will highlight the initial efficacy, acceptability, and feasibility of using digital positive psychology interventions to reduce subthreshold mental health concerns. Findings from this trial will also describe the safety of Peer Tree as a digital tool. Results will contribute evidence for positive psychology interventions to address mental ill-health. Trial registration: Australian New Zealand Clinical Trial Registry ACTRN12619000350123. Registered on 6 March 2020

A pilot digital intervention targeting loneliness in young people with psychosis

Purpose: Loneliness has been identified as a significant challenge for people with psychosis. Interventions targeting loneliness are lacking but adopting a positive psychology approach may reduce loneliness, promote well-being, and support meaningful social interactions. Together with youth mental health consumers, we developed a digital smartphone application (app) called +Connect, which delivers positive psychology content daily for 6 weeks. Materials and methods: Twelve participants diagnosed with a psychotic disorder were recruited from early psychosis services. Loneliness was assessed pre-intervention, post-intervention, and 3-month post-intervention. Acceptability, feasibility, and usability were measured post-intervention, including a semi-structured interview on the user’s experience of +Connect. Results: We found evidence for the feasibility of +Connect. All but two participants completed the +Connect program, completing 95% (40.10 out of 42 days) of the program. Furthermore, 66.67% (8 out of the 12 participants) remained engaged with the program 3-months post-intervention. Our data indicates preliminary evidence that +Connect may reduce loneliness, with scores from pre-intervention (M = 50.00, SD = 8.47) to post-intervention (M = 48.10, SD = 10.38) and 3-months post-intervention (M = 42.89, SD = 7.04). We found that positive reinforcement of in-game rewards and evidence of positive mood changes added to the feasibility of the app. Regarding acceptability, while 10% (1/10 participants) reported not finding +Connect useful or enjoyable, 90% of participants agreed that +Connect helped them to increase their social confidence, enjoy life, look forward to being with other people, and feel more connected with others. Participant interviews supported these results, with participants highlighting the app’s strengths in providing useful information, stimulating self-reflection, fostering positive affect, and encouraging transfer of skills into their social interactions. Discussion: While preliminary findings indicated that +Connect yielded high levels of acceptability and feasibility, it is important to consider that we recruited a small and selected sample of lonely young people. Further iterations of this proof of concept app, which can incorporate participant feedback such preferences for increased personalisation, in-app feedback, and gamification, may allow an opportunity to test an improved version in the future