Comparing Mindfulness Based Cognitive Therapy to Cognitive Behavioral Therapy for Youth at High Risk for Mood and Psychotic Disorders: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change from Baseline Children's Depression Rating Scale-Revised (CDRS-R; Poznanski & Mokros, 1996) scores at 9 weeks & 6 months.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from Baseline Children's Depression Rating Scale-Revised (CDRS-R; Poznanski & Mokros, 1996) scores at 9 weeks & 6 months.
时间窗: 0 & 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.
Change from Baseline Prodromal Questionnaire - Brief (PQ-B; Loewy, Pearson, Vinogradov, Bearden, & Cannon, 2011) scores at 9 weeks & 6 months
时间窗: 0 & 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.
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
时间窗: 0 & 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.
Change from Baseline Young Mania Rating Scale (YMRS; Young, Biggs, Ziegler, & Meyer, 1978) scores at 9 weeks & 6 months
时间窗: 0 & 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.
Change from Baseline Children's Global Assessment Scale (C-GAS; Shaffer, 1983) scores at 9 weeks & 6 months
时间窗: 0 & 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.
次要结局
- Change from Baseline Brief COPE Inventory (Brief-COPE; Carver, 1997) scores at 9 weeks & 6 months(0 & 9 weeks, 6 months)
- 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)
研究者
David J. Miklowitz, Ph.D.
Principal Investigator
University of California, Los Angeles