CompletedNot Applicable

MBCT and CBT for Youth at High Risk for Mood and Psychotic Disorders: a Randomized Controlled Trial

United States66 participantsStarted 2020-01-14

Plain-language summary

The present study is a randomized controlled trial comparing the efficacy and acceptability of CBT and MBCT group-based interventions adapted for young people at elevated risk for mood or psychotic disorder onset or relapse. Young people (ages 13-24) are provided with targeted psychoeducation and learn a variety of coping skills and wellness practices for mood regulation and stress and distress management. Parents meet separately to learn the same skills and receive guidance in supporting their youth with skill development. The therapy is also augmented by a mobile phone application that supports regular symptom monitoring and skills practice.

Who can participate

Age range

9 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Patient meets criteria for having experienced a (past or present) disorder marked by clinically significant mood instability, depression, and/or psychotic features (i.e., diagnosed with a mood disorder, adjustment disorder with depressed mood, or psychotic disorder) OR they are at clinical high risk for psychosis Exclusion Criteria: * Patient's current severity of illness interferes with participation in a group treatment (e.g., preoccupied with internal stimuli) * Patient has a current substance use disorder * Patient has a pervasive developmental disorder or intellectual disability * Patient cannot speak and read English sufficiently to allow for valid interpretation of a clinical assessment provided in English

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline Children's Depression Rating Scale-Revised (CDRS-R; Poznanski & Mokros, 1996) scores at 9 weeks & 6 months.

Timeframe: 0 & 9 weeks, 6 months

Change from Baseline in Questionnaire for Measuring Health-Related Quality of Life in Children (KINDL; Ravens-Sieberer & Bullinger, 1998) scores at 9 weeks & 6 months

Timeframe: 0 & 9 weeks, 6 months

Change from Baseline Children's Global Assessment Scale (C-GAS; Shaffer, 1983) scores at 9 weeks & 6 months

Timeframe: 0 & 9 weeks, 6 months

Change from Baseline Young Mania Rating Scale (YMRS; Young, Biggs, Ziegler, & Meyer, 1978) scores at 9 weeks & 6 months

Timeframe: 0 & 9 weeks, 6 months

Change from Baseline Prodromal Questionnaire - Brief (PQ-B; Loewy, Pearson, Vinogradov, Bearden, & Cannon, 2011) scores at 9 weeks & 6 months

Timeframe: 0 & 9 weeks, 6 months

Trial details

NCT IDNCT05070052

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-09

View on ClinicalTrials.gov More Mood Disorders trials

Plain-language summary

Who can participate

Age range

9 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from Baseline Children's Depression Rating Scale-Revised (CDRS-R; Poznanski & Mokros, 1996) scores at 9 weeks & 6 months.

Timeframe: 0 & 9 weeks, 6 months

Change from Baseline in Questionnaire for Measuring Health-Related Quality of Life in Children (KINDL; Ravens-Sieberer & Bullinger, 1998) scores at 9 weeks & 6 months

Timeframe: 0 & 9 weeks, 6 months

Change from Baseline Children's Global Assessment Scale (C-GAS; Shaffer, 1983) scores at 9 weeks & 6 months

Timeframe: 0 & 9 weeks, 6 months

Change from Baseline Young Mania Rating Scale (YMRS; Young, Biggs, Ziegler, & Meyer, 1978) scores at 9 weeks & 6 months

Timeframe: 0 & 9 weeks, 6 months

Change from Baseline Prodromal Questionnaire - Brief (PQ-B; Loewy, Pearson, Vinogradov, Bearden, & Cannon, 2011) scores at 9 weeks & 6 months

Timeframe: 0 & 9 weeks, 6 months