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

Not Applicable

Active, not recruiting

• Conditions: Depression; Mental Health - Depression

• Registration Number: ACTRN12619001412123
• Lead Sponsor: Orygen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-15
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 246

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 episode) if current MDD or MDD in full remission at time of screening assessment.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[ 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. ]