NCT01923701

Cognitive Behavioral Therapy for the Prevention of Paranoia in Adolescents at High Risk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 12 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• ARMS
• APS
• Prodromal Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy	GF-CBT focuses on teaching emotional self-regulation, information processing, decision making strategies,and logical thinking skills. The program is comprised of three parts: 1) Group sessions in which adolescents receive social support from peers who have had similar experiences and learn CBT skills, 2) Family group sessions in which family members learn more about adolescents' experiences and learn CBT skills so that they can encourage and reinforce these skills at home, and 3) Individual sessions in which adolescents can apply CBT skills to their own lives and work toward personal goals. Group sessions are taught with Powerpoint slides and with an accompanying workbook.

Timeline

• Start date: 2012-10-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2013-08-15
• Last updated: 2018-12-04

Locations

1 site across 1 country: United States