Data

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

Orygen

Dataset description

The study aims to evaluate, via a randomised controlled trial (RCT), the effectiveness of Rebound, a moderated online social networking system in preventing relapse of Major Depressive Disorder (MDD) in young people (aged 14-27) with remitted MDD. Rebound 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 newsfeed and a problem-solving forum. The social network will be moderated by experienced mental health workers and trained peer workers with lived experience of mental ill-health. Enhanced TAU includes access to a private website with information about depression symptoms, causes and course, the relationship between behaviour and mood, information on diet, exercise, sleep, social support and getting support. Enhanced TAU does not include therapist support or online social networking. The primary hypothesis of the study is that, relative to enhanced TAU, TAU plus Rebound will reduce relapse rates among remitted young people with MDD.
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Source Study

Purpose

Treatment

Phase

Not Applicable

Funding

Government body,National Health and Medical Research Council

Scientific enquiries

Mrs Daniela Cagliarini

Brief Summary

The study aims to evaluate, via a randomised controlled trial (RCT), the effectiveness of Rebound, a moderated online social networking system in preventing relapse of Major Depressive Disorder (MDD) in young people (aged 14-27) with remitted MDD. Rebound 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 ....
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Key Inclusion Criteria

1. Age 14 to 27 years inclusive; 2. Ability to read and converse in English; 3. Ability to provide informed consent; 4. Ability and willingness to nominate an emergency contact person, such as a close family member; 5. Diagnosis of MDD (current, partial or full remission) Current or previous primary diagnosis of MDD (corresponding with the most recent episode of care); 6. = 1 episode of MDD if in partial remission at time of screening assessment or = 2 episodes of MDD (including the current epis ....
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Key Exclusion Criteria

1. Inability to converse in, or read English; 2. Acute risk of self-harm requiring urgent intervention (i.e., suicidal ideation with a current plan and intent to enact this plan); 3. A diagnosed permanent developmental delay or intellectual disability; 4. Current or past episode of mania or hypomania; 5. Previous exposure to a MOST platform.

Can healthy volunteers participate?

No

 

Population

Sample Size    255

Min. age    14 Years

Max. age    27 Years

Sex    Both males and females

Condition category    Depression

Condition code    Mental Health

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 ....
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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 ....
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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 ....

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Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

All of the individual trial-related participant data collected during the trial, after de-identification.

When will data be available?

Immediately following publication up and for a further 3 years

Available to whom?

Data are potentially available to: - Researchers from not-for-profit organisations - Commercial organisations - Other Based in: - Any location Further information: All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.

Available for what types of analyses?

Any approved protocol, IPD meta-analysis or systematic review. Assessed on a case-by-case basis.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au