Clinical trial NCT01923701: Cognitive Behavioral Therapy for the Prevention of Paranoia in Adolescents at High Risk
Official title: Cognitive Behavioral Therapy for the Prevention of Paranoia in Adolescents at High Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARMS
APS
Prodromal Symptoms
Keywords: At Risk Mental State
Attenuated Psychosis Syndrome
Prodrom
Paranoia
Psychosis
Cognitive Behavioral Therapy
Group
Family
ARMS
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Sidney R. Baer, Jr. Foundation
First posted: 2013-08-15
Enrollment: 13
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in CAARMS from Baseline
timeFrame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)
Secondary outcomes:
measure: Change in Depressive Symptoms from Baseline
timeFrame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)
measure: Change in Anxiety Symptoms from Baseline
timeFrame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)
measure: Change in PDI Score from Baseline
timeFrame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)
measure: Change in Perceived Stress from Baseline
timeFrame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)
measure: Change in Role and Social Functioning from Baseline
timeFrame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)
measure: Change in Social Functioning from Baseline
timeFrame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)
measure: Change in Cognitive Biases from Baseline
timeFrame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)
measure: Change from Baseline in a Tendency to Jump to Conclusions
timeFrame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 17, and 29)
measure: Change in Family Member's Perceived Stress from Baseline
timeFrame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)
measure: Change in Perceived Family Member Empathy from Baseline
timeFrame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)
Other outcomes:
measure: The Working Alliance Inventory (WAI)
timeFrame: Assessed at Post-CBT (month 5)
measure: The Empathy Scale (ES)
timeFrame: Assessed at Post-CBT (month 5)
measure: Group Cohesiveness Scale (GCS)
timeFrame: Assessed at Post-CBT (month 5)
measure: Change in Family Member's CBT Skills from Baseline
timeFrame: Assessed at baseline, Post-CBT (month 5), and select follow-up assessments (months 9, 17, and 29)
measure: Therapeutic Factors in Group Pychotherapy
timeFrame: Assessed at Post-CBT (month 5)
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Yulia Landa, Psy.D., M.S.
role: PRINCIPAL_INVESTIGATOR
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