NCT01923701

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 15, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

5.9 years

First QC Date

July 24, 2013

Last Update Submit

December 3, 2018

Conditions

ARMSAPSProdromal Symptoms

Keywords

At Risk Mental StateAttenuated Psychosis SyndromeProdromParanoiaPsychosisCognitive Behavioral TherapyGroupFamilyARMS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Change in Depressive Symptoms from Baseline

    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

    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

    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

    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

    Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)

  • +5 more secondary outcomes

Other Outcomes (5)

  • The Working Alliance Inventory (WAI)

    Assessed at Post-CBT (month 5)

  • The Empathy Scale (ES)

    Assessed at Post-CBT (month 5)

  • Group Cohesiveness Scale (GCS)

    Assessed at Post-CBT (month 5)

  • +2 more other outcomes

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

Cognitive Behavioral Therapy group receives group, individual, and family Cognitive Behavioral Therapy in addition to standard care.

Behavioral: Cognitive Behavioral Therapy

Monitoring

NO INTERVENTION

This group receives standard care only.

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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.

Also known as: Group and Family Based Cognitive Behavioral Therapy, GF-CBT
Cognitive Behavioral Therapy

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • meets criteria for ARMS (at Risk Mental State, assessed by CAARMS)
  • Elevated suspiciousness (PANSS,P6≥3)

You may not qualify if:

  • A diagnosis of any of the following:
  • Moderate to severe learning disability
  • Substance dependence
  • Organic impairment known to affect brain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related 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. doi: 10.1207/s15327752jpa6703_13.

    PMID: 8991972BACKGROUND

  • 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. doi: 10.1192/bjp.157.6.853.

    PMID: 2289094BACKGROUND

  • 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. doi: 10.1093/schbul/sbm029. Epub 2007 Apr 17.

    PMID: 17440198BACKGROUND

  • Dudley RE, John CH, Young AW, Over DE. Normal and abnormal reasoning in people with delusions. Br J Clin Psychol. 1997 May;36(2):243-58. doi: 10.1111/j.2044-8260.1997.tb01410.x.

    PMID: 9167864BACKGROUND

  • 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. doi: 10.1097/00005053-199104000-00003.

    PMID: 2007889BACKGROUND

  • 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.

    PMID: 18596619BACKGROUND

  • Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

    PMID: 3616518BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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. doi: 10.1016/j.schres.2005.03.007.

    PMID: 15905071BACKGROUND

  • Peters E, Garety P. Cognitive functioning in delusions: a longitudinal analysis. Behav Res Ther. 2006 Apr;44(4):481-514. doi: 10.1016/j.brat.2005.03.008.

    PMID: 15913544BACKGROUND

  • 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. doi: 10.1093/oxfordjournals.schbul.a007116.

    PMID: 15954204BACKGROUND

  • 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. doi: 10.1093/oxfordjournals.schbul.a033401.

    PMID: 10478789BACKGROUND

  • 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. doi: 10.1001/archpsyc.1992.01820080032005.

    PMID: 1637252BACKGROUND

  • 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. doi: 10.1080/j.1440-1614.2005.01714.x.

    PMID: 16343296BACKGROUND

MeSH Terms

Conditions

Prodromal SymptomsParanoid DisordersPsychotic Disorders

Interventions

Cognitive Behavioral TherapyPopulation Groups

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesDemographyPopulation Characteristics

Study Officials

  • Yulia Landa, Psy.D., M.S.

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2013

First Posted

August 15, 2013

Study Start

October 1, 2012

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

US(1)