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

NCT ID: NCT05070052

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2022-03-09

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 Health's 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.

Conditions

Mood Disorders; Prodromal Symptoms; Bipolar Disorder; Parents; Clinical High Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group CBT

9 group sessions lasting 75-90 minutes each. CBT starts with psychoeducation about emotions, their primary functions, and how our emotions can affect the way we think and behave. They next learn about behavioral strategies that can help them manage or overcome difficult emotions. Group members also complete gradual exposure exercises, which involve engaging with activities that elicit negative emotions. Finally, group members are taught cognitive skills to help them cope with difficult/stressful thoughts.

Group Type: EXPERIMENTAL

cognitive behavioral therapy

Intervention Type: BEHAVIORAL

9 sessions of CBT weekly treatment in group setting

Group MBCT

9 group sessions lasting 75-90 minutes each. The focus of sessions 1 through 4 will be learning to bring greater awareness to the present moment, on purpose, and nonjudgmentally. Appropriate responding is the focus of sessions 5 through 8. All skills are reviewed in session 9.

Group Type: EXPERIMENTAL

mindfulness-based cognitive therapy

Intervention Type: BEHAVIORAL

9 sessions of MBCT weekly treatment in group setting

Interventions

cognitive behavioral therapy

9 sessions of CBT weekly treatment in group setting

Intervention Type: BEHAVIORAL

mindfulness-based cognitive therapy

9 sessions of MBCT weekly treatment in group setting

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

David J. Miklowitz, Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Miklowitz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Danielle M. Denenny, PhD

Role: STUDY_DIRECTOR

University of California, Los Angeles

Marc J. Weintraub

Role: STUDY_DIRECTOR

University of California, San Diego

Locations

UCLA

Los Angeles, California, United States

Countries

United States

References

Weintraub MJ, Denenny D, Ichinose MC, Zinberg J, Morgan-Fleming G, Done M, Brown RD, Bearden CE, Miklowitz DJ. A randomized trial of telehealth mindfulness-based cognitive therapy and cognitive behavioral therapy groups for adolescents with mood or attenuated psychosis symptoms. J Consult Clin Psychol. 2023 Apr;91(4):234-241. doi: 10.1037/ccp0000782. Epub 2023 Jan 16.

Reference Type: DERIVED

PMID: 36649157 (View on PubMed)

Other Identifiers

14-000391

Identifier Type: -

Identifier Source: org_study_id