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

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status

Completed

Conditions

APS
Prodromal Symptoms
ARMS

Treatments

Behavioral: Cognitive Behavioral Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01923701
1007011164
KL2 RR024496 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment

13 patients

Sex

All

Ages

12 to 25 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

13 participants in 2 patient groups

Cognitive Behavioral Therapy
Experimental group
Description:
Cognitive Behavioral Therapy group receives group, individual, and family Cognitive Behavioral Therapy in addition to standard care.
Treatment:
Behavioral: Cognitive Behavioral Therapy
Monitoring
No Intervention group
Description:
This group receives standard care only.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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