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

Prodromal Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923701
• Other study ID #: 1007011164
• Secondary ID: KL2 RR024496
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: September 2018

Study information

• Verified date: December 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• APS
• ARMS
• Prodromal Symptoms

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Sidney R. Baer, Jr. Foundation

Country where clinical trial is conducted

United States, 

References & Publications (16)

Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. — View Citation

Birchwood M, Smith J, Cochrane R, Wetton S, Copestake S. The Social Functioning Scale. The development and validation of a new scale of social adjustment for use in family intervention programmes with schizophrenic patients. Br J Psychiatry. 1990 Dec;157:853-9. — View Citation

Cornblatt BA, Auther AM, Niendam T, Smith CW, Zinberg J, Bearden CE, Cannon TD. Preliminary findings for two new measures of social and role functioning in the prodromal phase of schizophrenia. Schizophr Bull. 2007 May;33(3):688-702. Epub 2007 Apr 17. — View Citation

Dudley RE, John CH, Young AW, Over DE. Normal and abnormal reasoning in people with delusions. Br J Clin Psychol. 1997 May;36 ( Pt 2):243-58. — View Citation

Garety PA, Hemsley DR, Wessely S. Reasoning in deluded schizophrenic and paranoid patients. Biases in performance on a probabilistic inference task. J Nerv Ment Dis. 1991 Apr;179(4):194-201. — View Citation

Han DH, Park DB, Choi TY, Joo SY, Lee MK, Park BR, Nishimura R, Chu CC, Renshaw PF. Effects of brain-derived neurotrophic factor-catecholamine-O-methyltransferase gene interaction on schizophrenic symptoms. Neuroreport. 2008 Jul 16;19(11):1155-8. doi: 10.1097/WNR.0b013e32830867ad. — View Citation

Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. — View Citation

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

Loewy RL, Bearden CE, Johnson JK, Raine A, Cannon TD. The prodromal questionnaire (PQ): preliminary validation of a self-report screening measure for prodromal and psychotic syndromes. Schizophr Res. 2005 Sep 15;77(2-3):141-9. — View Citation

Peters E, Garety P. Cognitive functioning in delusions: a longitudinal analysis. Behav Res Ther. 2006 Apr;44(4):481-514. — View Citation

Peters E, Joseph S, Day S, Garety P. Measuring delusional ideation: the 21-item Peters et al. Delusions Inventory (PDI). Schizophr Bull. 2004;30(4):1005-22. — View Citation

Peters ER, Joseph SA, Garety PA. Measurement of delusional ideation in the normal population: introducing the PDI (Peters et al. Delusions Inventory). Schizophr Bull. 1999;25(3):553-76. — View Citation

Spitzer RL, Williams JB, Gibbon M, First MB. The Structured Clinical Interview for DSM-III-R (SCID). I: History, rationale, and description. Arch Gen Psychiatry. 1992 Aug;49(8):624-9. — View Citation

Yung AR, Yuen HP, McGorry PD, Phillips LJ, Kelly D, Dell'Olio M, Francey SM, Cosgrave EM, Killackey E, Stanford C, Godfrey K, Buckby J. Mapping the onset of psychosis: the Comprehensive Assessment of At-Risk Mental States. Aust N Z J Psychiatry. 2005 Nov-Dec;39(11-12):964-71. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Working Alliance Inventory (WAI)	Measures the participants' perceived alliance to the therapist(WAI; Horvath & Greenberg, 1989).	Assessed at Post-CBT (month 5)
Other	The Empathy Scale (ES)	Measures participants' perceptions of the therapist's warmth, genuineness, and empathy(ES; Burns and Auerbach, 1996).	Assessed at Post-CBT (month 5)
Other	Group Cohesiveness Scale (GCS)	Measures group cohesiveness(CS; Stokes, 1983).	Assessed at Post-CBT (month 5)
Other	Change in Family Member's CBT Skills from Baseline	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).	Assessed at baseline, Post-CBT (month 5), and select follow-up assessments (months 9, 17, and 29)
Other	Therapeutic Factors in Group Pychotherapy	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).	Assessed at Post-CBT (month 5)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)