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

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ClinicalTrials.gov Identifier: NCT01923701
Recruitment Status : Recruiting
First Posted : August 15, 2013
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Sidney R. Baer, Jr. Foundation
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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).

Condition or disease Intervention/treatment Phase
ARMS APS Prodromal Symptoms Behavioral: Cognitive Behavioral Therapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cognitive Behavioral Therapy for the Prevention of Paranoia in Adolescents at High Risk
Study Start Date : October 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy group receives group, individual, and family Cognitive Behavioral Therapy in addition to standard care.
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.
Other Names:
  • Group and Family Based Cognitive Behavioral Therapy
  • GF-CBT

No Intervention: Monitoring
This group receives standard care only.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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.


Other Outcome Measures:
  1. The Working Alliance Inventory (WAI) [ Time Frame: Assessed at Post-CBT (month 5) ]
    Measures the participants' perceived alliance to the therapist(WAI; Horvath & Greenberg, 1989).

  2. The Empathy Scale (ES) [ Time Frame: Assessed at Post-CBT (month 5) ]
    Measures participants' perceptions of the therapist's warmth, genuineness, and empathy(ES; Burns and Auerbach, 1996).

  3. Group Cohesiveness Scale (GCS) [ Time Frame: Assessed at Post-CBT (month 5) ]
    Measures group cohesiveness(CS; Stokes, 1983).

  4. Change in Family Member's CBT Skills from Baseline [ Time Frame: Assessed at baseline, Post-CBT (month 5), and select follow-up assessments (months 9, 17, and 29) ]
    The Cognitive Behavioral Therapy Skills for Families Scale ( CBTSF-S) is used to measure parents or family members' use of Cognitive Behavioral Therapy skills (Landa et al., in preparation).

  5. Therapeutic Factors in Group Pychotherapy [ Time Frame: Assessed at Post-CBT (month 5) ]
    Measures the importance that youth and family members attribute to various therapeutic factors. Participants are asked to rank from 1 to 8 a number of statements about therapy(Bloch,et al.1979).



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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923701


Contacts
Contact: Yulia Landa, Psy.D., M.S. 212-821-0711 yul9003@med.cornell.edu
Contact: Rachel Jespersen 212-821-0623 raj2013@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Sidney R. Baer, Jr. Foundation
Investigators
Principal Investigator: Yulia Landa, Psy.D., M.S. Weill Medical College of Cornell University

Publications:
Landa Y; Chadwick P; Beck AT; Alexeenko L; Sheets M; Zhu Y; Silbersweig DA. (2011). Targeting information processing biases and social avoidance in group cognitive behavioral therapy for paranoia: A pilot randomized controlled clinical trial. Schizophr Bull; 37: 271-271.
Landa Y; Chadwick P; Stern E; Pan H; Alexeenko L; Zhu YH. . . . Silbersweig DA. Cognitive behavioral therapy for paranoia: A pilot randomized controlled clinical trial and fMRI investigation of systems-level brain circuit modulation. Biol Psychiatry 2012; 71(8): 65s-66s.
Landa Y; Silverstein S; Schwartz F; Savitz A. (2006). Group cognitive behavioral therapy for delusions: Helping patients improve reality testing. J Contemp Psychother; 36(1): 9-17. doi: 10.1007/s10879-005-9001-x

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01923701     History of Changes
Other Study ID Numbers: 1007011164
KL2 RR024496 ( Other Grant/Funding Number: Sidney J. Baer Foundation )
First Posted: August 15, 2013    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Keywords provided by Weill Medical College of Cornell University:
At Risk Mental State
Attenuated Psychosis Syndrome
Prodrom
Paranoia
Psychosis
Cognitive Behavioral Therapy
Group
Family
ARMS

Additional relevant MeSH terms:
Paranoid Disorders
Prodromal Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Signs and Symptoms