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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ARMS, APS, Prodromal Symptoms

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy<br>Cognitive Behavioral Therapy group receives group, individual, and family Cognitive Behavioral Therapy in addition to standard care. | Behavioral: Cognitive Behavioral Therapy<br>* 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.<br>* Other names: GF-CBT;|
| No Intervention: Monitoring<br>This group receives standard care only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CAARMS from Baseline | 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). | Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depressive Symptoms from Baseline | The Beck Depression Inventory-2nd edition (BDI-II) is used to evaluate depressive symptoms (Beck, Steer, Ball,& Ranieri, 1996). | 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 | The State-Trait Anxiety Inventory (STAI) is used to measure state and trait anxiety(Speilberger, 1966; Speilberger, 1983). | 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 | Peters' Delusions Inventory (PDI), a 21-item self-report questionnaire and is used to measure delusional ideation across multiple dimensions including distress, preoccupation and conviction (E. Peters, Joseph, Day, & Garety, 2004; E. R. Peters, Joseph, & Garety, 1999). | Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) | 
| Change in Perceived Stress from Baseline | The Perceived Stress Scale (PSS) is a 10-item self-report scale that measures the degree to which situations in one's life are appraised as stressful (Cohen, 1994). | 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 | The Global Functioning: Role (GFR) and Global Functioning: Social (GFS) scales are clinician administered scales, derived from the GAF format. The GFR scale anchor points refer to performance in school, work, or as a homemaker, depending on age. Ratings are also based on demands of the role, level of independence or support provided to the individual and the individual's overall performance in the role given the level of support. The GFS scale assesses quantity and quality of peer relationships, level of peer conflict, age appropriate intimate relationships, and involvement with family members. Age-appropriate social contacts and interactions outside of the family are considered, with an emphasis on social withdrawal and isolation (Cornblatt et al., 2007). | 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 | The Social Functioning Scale (SFS) is administered both as a self-report measure to adolescents and as an observer-report to family members who evaluated adolescents' in seven areas: (a) social engagement/withdrawal (time spent alone, initiation of conversations, social avoidance), (b) interpersonal behavior (number of friends, quality of communication), (c) pro-social activities (engagement in a range of common social activities, e.g. sports), (d) recreation (engagement in a range of common hobbies and interests), (e) independence-competence (ability to perform skills necessary for independent living, (f) independence-performance (performance of skills necessary for independent living) and (g) employment/occupation (engagement in productive employment or structured daily activity (Birchwood, Smith, Cochrane, Wetton, & Copestake, 1990). | 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 | The Davos Assessment of Cognitive Biases (DACOBS) measures cognitive biases and safety behaviors. DACOBS includes the following sub-scales: Jumping to Conclusions Bias, Belief Inflexibility Bias, Attention for Threat Bias, External Attribution Bias, Social Cognition Problems, Subjective Cognitive Problems, and Safety Behaviors (Van der Gaag et al., 2013). | 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 | Measured by the BEADS Task. Measures a tendency to jump to conclusions when making a judgment(Dudley, John, Young, & Over, 1997; P. A. Garety, Hemsley, & Wessely, 1991; E. Peters & Garety, 2006). | Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 17, and 29) | 
| Change in Family Member's Perceived Stress from Baseline | The Perceived Stress Scale (PSS) is a 10-item self-report scale that measures the degree to which situations in one's life are appraised as stressful (Cohen, 1994). | Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) | 
| Change in Perceived Family Member Empathy from Baseline | An adaptation of the Empathy Scale(Burns & Auerbach, 1996) is used to measure adolescents' perception of their family member's warmth, genuineness, and empathy. | Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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At Risk Mental State, Attenuated Psychosis Syndrome, Prodrom, Paranoia, Psychosis, Cognitive Behavioral Therapy, Group, Family, ARMS