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Cognitive Behavioral Therapy for Paranoia in Schizophrenia (CBTp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01704833
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE September 27, 2012
First Posted Date  ICMJE October 11, 2012
Last Update Posted Date December 4, 2018
Study Start Date  ICMJE September 2006
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
Change from Baseline in Persecution Severity at week 16 and at week 42. [ Time Frame: Measured at baseline, at week 16, and at week 42. ]
Measured by the Persecution sub-scale on Positive and Negative Syndrome Scale (PANSS).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01704833 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
  • Change from Baseline in Attributional Style at week 16. [ Time Frame: Measured at baseline and at week 16. ]
    Internal Personal and Situational Attributions Questionnaire.Measures attributional style (a tendency to attribute cause for negative events to situational or personal causes).
  • Change from Baseline in a Tendency to Jump to Conclusions at week 16. [ Time Frame: Measured at baseline and at week 16. ]
    Measured by the BEADS Task. Measures a tendency to jump to conclusions when making a judgment.
  • Change from Baseline in Cognitive Insight at week 16. [ Time Frame: Measured at baseline and at week 16. ]
    Beck Cognitive Insight Scale. Measures cognitive insight.
  • Change from Baseline in Dimensions of Paranoid Delusions [ Time Frame: Measured at baseline, at week 16 and at week 42. ]
    Psychotic Symptom Rating Scales (PSYRATS), Delusions. Measure dimensions of delusions.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 10, 2012)
  • The Working Alliance Inventory (WAI) [ Time Frame: Measured at week 16 (post CBT). ]
    Used to assess the participants' perceived alliance to the therapist.
  • The Empathy Scale (ES) [ Time Frame: Measured at week 16 (post CBT). ]
    Measures participants' perceptions of the therapist's warmth, genuineness, and empathy.
  • Group Cohesiveness Scale (GCS) [ Time Frame: Measured at week 16 (post CBT). ]
    Measures group cohesiveness.
  • Changes from Baseline in Brain Circuitry at week 42. [ Time Frame: Measured at baseline and at week 42. ]
    'Linguistic threat' fMRI paradigm is used to monitor brain circuitry changes associated with PFCBT.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Cognitive Behavioral Therapy for Paranoia in Schizophrenia
Official Title  ICMJE Cognitive Behavioral Therapy for Paranoia in Schizophrenia
Brief Summary The main objective of this study is to determine the preliminary efficacy of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) relative to standard care in the treatment of persecutory delusions in patients diagnosed with schizophrenia or schizoaffective Disorder.
Detailed Description

Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) is a manualized intervention that combines group and individual modalities to reduce paranoia-biased information-processing and social avoidance, and to increase insight and reality testing capacity.

This is a randomized controlled clinical trial. Twenty four adults ages 18-65 with the primary DSM-IV Schizophrenia and Schizoaffective disorder and drug-refractory persecutory delusions will be recruited from outpatient clinics in New York City Metropolitan area. Participants will be randomly assigned to either experimental or control group. The experimental group will receive PFCBT in addition to standard care and the control group will receive standard care alone. PFCBT will include participation in one group session and one individual therapy session weekly over the 15 weeks. The preliminary efficacy of the intervention will be evaluated using standardized measures by blind evaluators conducted at baseline, post-treatment, and at 6-months post-termination follow-up.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Paranoid Delusions
Intervention  ICMJE Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)
The PFCBT is a 15-week Program that includes weekly group and individual sessions.
Study Arms  ICMJE
  • Experimental: Cognitive Behavioral Therapy
    This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care.
    Intervention: Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)
  • No Intervention: Treatment as Usual
    This group receives standard care only.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2012)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 65 years
  • Met DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder, confirmed by the Clinical Structural Diagnostic Interview (SCID, First et al, 1997) -Reported persistent and distressing paranoid delusion(s);
  • A minimum severity score of 4 point Persecution subscale on The Positive and Negative Syndrome Scale (PANSS)
  • Had an adequate trial (6 months or more) and were stabilized on antipsychotic medications (no change in psychiatric medication prescribed in the last month

Exclusion Criteria:

-Substance misuse or medical disorder identified as the primary cause of delusions

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01704833
Other Study ID Numbers  ICMJE 0505007908
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE National Alliance for Research on Schizophrenia and Depression
Investigators  ICMJE
Principal Investigator: Yulia Landa, Psy D. Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP