Preventing relapse of major depressive disorder in youth: Randomised Controlled Trial of a novel mindfulness-based cognitive online social therapy

Intervention

Intervention code Behaviour , Prevention , Treatment: Other

The intervention under investigation is a moderated online social networking system, called Rebound. Rebound is an online intervention specifically designed to prevent relapse in youth Major Depressive Disorder (MDD) and includes therapeutic activities and information about mental health, mindfulness, personal strengths, and other topics relevant for young people recovering from MDD. Rebound also includes a social network where participants can communicate via posts and comments in a news feed a .... The intervention under investigation is a moderated online social networking system, called Rebound. Rebound is an online intervention specifically designed to prevent relapse in youth Major Depressive Disorder (MDD) and includes therapeutic activities and information about mental health, mindfulness, personal strengths, and other topics relevant for young people recovering from MDD. Rebound also includes a social network where participants can communicate via posts and comments in a news feed and a problem-solving forum. The online platform will be moderated by experienced mental health workers based at Orygen Youth Health. Trained peer workers with lived experience of mental ill-health will also provide support to participants through the Rebound social network. Following randomisation, participants allocated to the Rebound intervention will complete an online orientation and follow-up phone call with the online moderator. Participants will access Rebound (including individualised therapist support) for 18 months. During this period, participants may access Rebound as often as they like, at any time, from any internet-enabled device. Rebound integrates online personal therapist support (by clinical psychologists). Their role is to provide guidance, monitor participant’s activity and clinical status and ensure the safety of the social network. Each therapist is assigned a caseload, which they follow for the duration of the trial. Moderators send each client tailored content suggestions weekly (e.g. a module or action) based on their needs and interests. Clients can rate the helpfulness of the suggestions, which moderators use to recommend subsequent content. Participant logins are monitored by the moderator. When a participant has not logged in for more than 7 days, this will be reviewed at moderator supervision. To promote engagement, retention of participants, and behavioural change, Rebound was developed following persuasive system design including primary task support (i.e., modularisation and personalisation of content), social support (i.e., fully integrated, purpose-built social network) and dialogue support (i.e., reward provided by therapists, peer-supporters and automated functions). Users will be invited by moderators to meet other users at ‘Rebound meet-ups’. Meet-ups will consist of an interactive 1-hour session on ‘how to make Rebound work for you’ and will provide users with the opportunity to ask questions and give feedback on the system. Participants will be reimbursed for their time. In the event of a clinically significant deterioration of depressive symptoms, increased risk or a hospital admission, the clinical moderators in conjunction with the CI team will perform an assessment to determine the risks and benefits of a temporary withdrawal from Rebound. Based on this assessment, and in consultation with the young person, the team will determine whether the account is temporarily suspended, or level of access restricted (e.g., participant can access therapeutic content and support from moderators, and view content in the social network, but cannot post comments or participate in existing threads within the social network). All instances of depressive relapse will be reported to the Project Manager and recorded as an Adverse Event. Following suspensions or restrictions to a user’s account, the study coordinator or moderator will contact the young person at fortnightly intervals to ascertain whether the account is to be reactivated. All participant activity (frequency, duration, pattern of use etc.) on the system is recorded by system data analytics.
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Comparison

Control group Active

Treatment As Usual (TAU) consists of a range of treatment options delivered by Youth Mood Clinic, Orygen Youth Health or headspace treating teams prior to discharge or, after discharge, generic medical or mental health services typically available to young people in the absence of enrolment in the study. These can include follow-up by a general practitioner, private psychiatrist, primary care youth mental health services, or adult mental health services which deliver multidisciplinary psychiatri .... Treatment As Usual (TAU) consists of a range of treatment options delivered by Youth Mood Clinic, Orygen Youth Health or headspace treating teams prior to discharge or, after discharge, generic medical or mental health services typically available to young people in the absence of enrolment in the study. These can include follow-up by a general practitioner, private psychiatrist, primary care youth mental health services, or adult mental health services which deliver multidisciplinary psychiatric care (including medical follow-up, case management and acute psychiatric care as appropriate). To ensure the consistency and quality of TAU, online psychoeducation will be offered to those allocated to the control group (enhanced TAU). Psychoeducation is beneficial as an adjunct treatment for depression and is readily translated into web-format (Tursi et al., 2013). We have developed Empower Your Mood (EYM), a web application that includes psycho-education modules on depression symptoms, causes and course, behaviour and mood, information on diet, exercise, sleep, social support and getting support. EYM does not include therapist support or online social networking. All modules will be available for 18 months to match Rebound’s time frame.
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Outcomes

Outcome: The primary outcome is relapse rate of Major Depressive Disorder (MDD). Relapse will be defined as a return, for at least 2 weeks, of symptoms sufficient to meet DSM-5 criteria for MDD (as determined by the SCID-5-RV) at any time in the 18 months post-baseline.
Timepoint: Baseline, then 3 months, 6 months, 9 months, 12 months, 15 months and 18 months (primary timepoint) after randomisation. Baseline, 6, 12 and 18 month assessments will be carried out via face-to-fac .... Outcome: The primary outcome is relapse rate of Major Depressive Disorder (MDD). Relapse will be defined as a return, for at least 2 weeks, of symptoms sufficient to meet DSM-5 criteria for MDD (as determined by the SCID-5-RV) at any time in the 18 months post-baseline.
Timepoint: Baseline, then 3 months, 6 months, 9 months, 12 months, 15 months and 18 months (primary timepoint) after randomisation. Baseline, 6, 12 and 18 month assessments will be carried out via face-to-face interviews. Assessments at 3, 9 and 15 months, will be conducted over the phone. The accumulated relapse rate across these assessment will constitute the primary outcome.
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