Cognitive Behavioral Therapy for the Prevention of Paranoia in Adolescents at High Risk
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ARMS
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Change in CAARMS from Baseline
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •meets criteria for ARMS (at Risk Mental State, assessed by CAARMS)
- •Elevated suspiciousness (PANSS,P6≥3)
Exclusion Criteria
- •A diagnosis of any of the following:
- •Moderate to severe learning disability
- •Substance dependence
- •Organic impairment known to affect brain
Outcomes
Primary Outcomes
Change in CAARMS from Baseline
Time Frame: 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).
Secondary Outcomes
- 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))