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

NCT05070052 | Completed

• 1 other identifier: 14-000391
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

group therapy; psychotherapy; psychoeducation; skills training; mood disorders; prodromal psychosis; adolescents; parent group; youth

Outcome Measures

Primary Outcomes (5)

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

  Semi-structured interview of youth and parent to assess recent severity of youth depression. Consensus scores are obtained for 17 items, with total scores ranging from 17 to 113 and higher scores indicating more severe depression.

  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

  Self-report measure of health-related quality of life in children and adolescents. Both the parent-report scale (24-item) \& adolescent-report scale (31-item) are included, with higher total scale scores (range 0 to 100) indicating more severe problems with health-related quality of life.

  0 & 9 weeks, 6 months

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

  Assessor-rated rating of current global functioning, considering illness severity. Scores range from 1 to 100, with higher scores indicating better global functioning.

  0 & 9 weeks, 6 months

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

  Semi-structured interview of youth and parent on recent manic mood symptoms. Consensus scores are obtained from 11 items, with total scale scores ranging from 0 to 60 and higher scores indicating more severe manic symptoms.

  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

  Patient self-report measure of current severity of positive clinical high risk for psychosis symptoms. Total score is based on 21 items and represents higher level of positive symptomatology, considering associated distress and impact.

  0 & 9 weeks, 6 months

Secondary Outcomes (3)

• Change from Baseline Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) scores at 9 weeks & 6 months

  0 & 9 weeks, 6 months

• Change from Baseline Depression Anxiety Stress Scales-21 (DASS-21; Lovibond & Lovibond, 1995) scores at 9 weeks & 6 months

  0 & 9 weeks, 6 months

• Change from Baseline Brief COPE Inventory (Brief-COPE; Carver, 1997) scores at 9 weeks & 6 months

  0 & 9 weeks, 6 months

Study Arms (2)

Group CBT

EXPERIMENTAL

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.

Behavioral: cognitive behavioral therapy

Group MBCT

EXPERIMENTAL

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.

Behavioral: mindfulness-based cognitive therapy

Interventions

cognitive behavioral therapy BEHAVIORAL

9 sessions of CBT weekly treatment in group setting

Group CBT

mindfulness-based cognitive therapy BEHAVIORAL

9 sessions of MBCT weekly treatment in group setting

Group MBCT

Eligibility Criteria

• Age: 9 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• 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.

  PMID: 36649157 DERIVED

MeSH Terms

Conditions

Mood Disorders; Prodromal Symptoms; Bipolar Disorder

Interventions

Cognitive Behavioral Therapy; Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mindfulness

Study Officials

• David Miklowitz, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Danielle M. Denenny, PhD

  University of California, Los Angeles

  STUDY DIRECTOR

• Marc J. Weintraub

  University of California, San Diego

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: October 6, 2021
• Study Start: January 14, 2020
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)