An interventional study of cognitive behavioral therapy and mindfulness-based cognitive therapy in Mood Disorders, Prodromal Symptoms and Bipolar Disorder, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 9 Years to 25 Years. Per ClinicalTrials.gov, last updated 2022-10-12.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
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.
1,601 studies on the registry are indexed under Bipolar Disorder; 255 are open to participants now.
This study's enrollment of 66 is close to the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
9 sessions of CBT weekly treatment in group setting
9 sessions of MBCT weekly treatment in group setting
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0 & 9 weeks, 6 months
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.
Time frame: 0 & 9 weeks, 6 months
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.
Time frame: 0 & 9 weeks, 6 months
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.
Time frame: 0 & 9 weeks, 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Prodromal Symptoms
University of California, Los Angeles