Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05070052
Other study ID # 14-000391
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 14, 2020
Est. completion date March 9, 2022

Study information

Verified date October 2022
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date March 9, 2022
Est. primary completion date March 9, 2022
Accepts healthy volunteers No
Gender All
Age group 9 Years to 25 Years
Eligibility 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

Study Design


Intervention

Behavioral:
cognitive behavioral therapy
9 sessions of CBT weekly treatment in group setting
mindfulness-based cognitive therapy
9 sessions of MBCT weekly treatment in group setting

Locations

Country Name City State
United States UCLA Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Change from Baseline Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) scores at 9 weeks & 6 months Parental self-report measure of their own difficulties in emotion regulation. Total scores on this 36-item instrument range from 36 to 180, with higher scores indicating more severe personal difficulties with emotion regulation. 0 & 9 weeks, 6 months
Secondary Change from Baseline Depression Anxiety Stress Scales-21 (DASS-21; Lovibond & Lovibond, 1995) scores at 9 weeks & 6 months Parental self-report measure of their own difficulties with depression, anxiety and stress. Total scores on this 21-item instrument range from 0 to 63, with higher scores indicating more severe personal difficulties with emotion regulation. 0 & 9 weeks, 6 months
Secondary Change from Baseline Brief COPE Inventory (Brief-COPE; Carver, 1997) scores at 9 weeks & 6 months Youth self-report measure of their use of emotional behavioral coping strategies for stressful situations. Scores for the 28-item measure range from 28 to 112, with higher scores indicating greater use of coping strategies. 0 & 9 weeks, 6 months
See also
  Status Clinical Trial Phase
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT02855762 - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder N/A
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Completed NCT02513654 - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects Phase 1
Recruiting NCT06313918 - Exercise Therapy in Mental Disorders-study N/A
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1
Recruiting NCT06197048 - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT02212041 - Electronic Cigarettes in Smokers With Mental Illness N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Not yet recruiting NCT04432116 - Time and Virtual Reality in Schizophrenia and Bipolar Disorder N/A
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Terminated NCT02893371 - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Terminated NCT02909504 - Gao NARASD Lithium Study Phase 4
Recruiting NCT02481245 - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study Phase 2
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study