Ignite Creation Date:
2024-05-06 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05070052
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2021-07-20
Brief Title:
MBCT and CBT for Youth at High Risk for Mood and Psychotic Disorders a Randomized Controlled Trial
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Comparing Mindfulness Based Cognitive Therapy to Cognitive Behavioral Therapy for Youth at High Risk for Mood and Psychotic Disorders a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Psychosocial interventions that improve emotional health and stability could have a dramatically favorable impact on individual suffering among adolescents and young adults at risk for severe mental illness as well as their family members Unfortunately youth who are at risk for bipolar disorder or psychosis are treated with a wide variety of medications and therapies with little evidence-based practice
The main objective of this study is to investigate the comparative efficacy and acceptability of weekly outpatient group-based Mindfulness based Cognitive Therapy MBCT and Cognitive Behavioral Therapy CBT adapted for youth at elevated risk for serious or persistent mood disorders or psychosis Consistent with the National Institute of Mental Healths shift towards common underlying mechanisms across diagnoses Research Domain Criteria or RDoc Sanislow et al 2010 recruitment for this study is transdiagnostic targeting a range of youth with difficulties with mood dysregulation and stress
All randomized control trial RCT participants receive one of the two active treatments The order of treatment groups has been randomized with participants blinded to their treatment assignment Five to 15 young participants of similar age teen or young adult comprise each group Parents receive a parallel parent-only group that informs them of the content and skills presented to their offspring
The investigators will assess emotion dysregulation psychiatric symptoms overall functioning and quality of life at baseline immediately following the 9-week treatment and at follow-up 3 months after therapy ends
Clinical symptoms cognitions mindfulness emotion regulation and well-being will be measured at baseline and each follow-up assessment Both youth and young adults will participate in a follow-up assessment immediately after the intervention Youth participants will participate in a second follow-up assessment 12 weeks post-treatment
The main investigative hypotheses are that both the MBCT and CBT programs will be acceptable to the young participants and parents and associated with high satisfaction ratings Additionally the investigators anticipate that both MBCT and CBT will be associated with comparable improvements in mood anxiety and psychotic symptoms and social functioning from pretreatment to final follow-up Finally the investigators anticipate that increases in mindfulness and reductions in negative cognitions from pretreatment to post-treatment and follow-up will be correlated with improvements in the young participants self-reported emotional dysregulation and attention
The study aims to add to the body of knowledge on evidence-based interventions targeting mood and stress pathways for youth at risk for chronic or serious mental health challenges
The main objective of this study is to investigate the comparative efficacy and acceptability of weekly outpatient group-based Mindfulness based Cognitive Therapy MBCT and Cognitive Behavioral Therapy CBT adapted for youth at elevated risk for serious or persistent mood disorders or psychosis Consistent with the National Institute of Mental Healths shift towards common underlying mechanisms across diagnoses Research Domain Criteria or RDoc Sanislow et al 2010 recruitment for this study is transdiagnostic targeting a range of youth with difficulties with mood dysregulation and stress
All randomized control trial RCT participants receive one of the two active treatments The order of treatment groups has been randomized with participants blinded to their treatment assignment Five to 15 young participants of similar age teen or young adult comprise each group Parents receive a parallel parent-only group that informs them of the content and skills presented to their offspring
The investigators will assess emotion dysregulation psychiatric symptoms overall functioning and quality of life at baseline immediately following the 9-week treatment and at follow-up 3 months after therapy ends
Clinical symptoms cognitions mindfulness emotion regulation and well-being will be measured at baseline and each follow-up assessment Both youth and young adults will participate in a follow-up assessment immediately after the intervention Youth participants will participate in a second follow-up assessment 12 weeks post-treatment
The main investigative hypotheses are that both the MBCT and CBT programs will be acceptable to the young participants and parents and associated with high satisfaction ratings Additionally the investigators anticipate that both MBCT and CBT will be associated with comparable improvements in mood anxiety and psychotic symptoms and social functioning from pretreatment to final follow-up Finally the investigators anticipate that increases in mindfulness and reductions in negative cognitions from pretreatment to post-treatment and follow-up will be correlated with improvements in the young participants self-reported emotional dysregulation and attention
The study aims to add to the body of knowledge on evidence-based interventions targeting mood and stress pathways for youth at risk for chronic or serious mental health challenges
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None