Cognitive Behavioral Therapy for the Prevention of Paranoia in Adolescents at High Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in CAARMS from Baseline
研究概览
简要总结
The main objective of this study is to decrease the severity of symptoms and improve psycho-social functioning in youth at high risk of developing psychosis by providing a specialized Group-and-Family-based Cognitive Behavioral Therapy (GF-CBT).
详细描述
24 adolescents and young adults between the ages of 12 and 25 who are at high risk of developing psychosis and exhibit paranoid ideation will be recruited to participate in a pilot randomized controlled trial. Subjects will be randomly assigned to the intervention (GF-CBT)or control (symptom monitoring) groups. GF-CBT is based on a cognitive neuropsychiatric model of delusions, and incorporates recent developments in learning and cognitive theories. GF-CBT consists of individual, group, and family group sessions. The three-part program teaches adolescents and family members Cognitive Behavioral skills that they can continue using on their own after completion of the program. Preliminary efficacy of the intervention will be evaluated using standardized measures by blind evaluators conducted at baseline, post-treatment, and post-termination follow-up over the next 2 years. Hypotheses: (a) GF-CBT will be associated with: high rate of remission from "at risk status" and low rates of transition to psychosis (defined by CAARMS criteria); greater improvements in severity of symptoms; and improved functioning; (b) decrease in family members'level of stress, and improved coping; (c) Family members will demonstrate proficiency in CBT Skills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •meets criteria for ARMS (at Risk Mental State, assessed by CAARMS)
- •Elevated suspiciousness (PANSS,P6≥3)
排除标准
- •A diagnosis of any of the following:
- •Moderate to severe learning disability
- •Substance dependence
- •Organic impairment known to affect brain
研究组 & 干预措施
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy group receives group, individual, and family Cognitive Behavioral Therapy in addition to standard care.
干预措施: Cognitive Behavioral Therapy (Behavioral)
Monitoring
This group receives standard care only.
结局指标
主要结局
Change in CAARMS from Baseline
时间窗: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)
Measured by the CAARMS-Comprehensive Assessment of At-Risk Mental State (Yung et al., 2005), a clinician-administered semi-structured interview. The CAARMS includes the following subscales: disorders of thought content, perceptual abnormalities, conceptual disorganization, disorganized speech, motor changes, concentration and attention, emotion and affect, subjectively impaired energy and impaired tolerance to normal stress, as well as a measure of functioning called the Social and Occupational Functioning Scale (SOFAS).
次要结局
- Change in Perceived Stress from Baseline(Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29))
- Change in Family Member's Perceived Stress from Baseline(Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29))
- Change in Depressive Symptoms from Baseline(Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29))
- Change in Anxiety Symptoms from Baseline(Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29))
- Change in PDI Score from Baseline(Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29))
- Change in Role and Social Functioning from Baseline(Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29))
- Change in Social Functioning from Baseline(Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29))
- Change in Cognitive Biases from Baseline(Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29))
- Change from Baseline in a Tendency to Jump to Conclusions(Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 17, and 29))
- Change in Perceived Family Member Empathy from Baseline(Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29))