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

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Weill Medical College of Cornell University

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Depressive Symptoms from Baseline [ Time Frame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) ]
    The Beck Depression Inventory-2nd edition (BDI-II) is used to evaluate depressive symptoms (Beck, Steer, Ball,& Ranieri, 1996).
  • Change in Anxiety Symptoms from Baseline [ Time Frame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) ]
    The State-Trait Anxiety Inventory (STAI) is used to measure state and trait anxiety(Speilberger, 1966; Speilberger, 1983).
  • Change in PDI Score from Baseline [ Time Frame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) ]
    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).
  • Change in Perceived Stress from Baseline [ Time Frame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) ]
    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).
  • Change in Role and Social Functioning from Baseline [ Time Frame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) ]
    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).
  • Change in Social Functioning from Baseline [ Time Frame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) ]
    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).
  • Change in Cognitive Biases from Baseline [ Time Frame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) ]
    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).
  • Change from Baseline in a Tendency to Jump to Conclusions [ Time Frame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 17, and 29) ]
    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).
  • Change in Family Member's Perceived Stress from Baseline [ Time Frame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) ]
    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).
  • Change in Perceived Family Member Empathy from Baseline [ Time Frame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29) ]
    An adaptation of the Empathy Scale(Burns & Auerbach, 1996) is used to measure adolescents' perception of their family member's warmth, genuineness, and empathy.
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    Original Secondary Outcome: Same as current

    Information By: Weill Medical College of Cornell University

    Dates:
    Date Received: July 24, 2013
    Date Started: October 2012
    Date Completion: December 2016
    Last Updated: August 13, 2013
    Last Verified: August 2013