Clinical Trial: Cognitive Behavioral Therapy for Paranoia in Schizophrenia

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

Official Title: 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 Summary:

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.


Sponsor: Weill Medical College of Cornell University

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Weill Medical College of Cornell University

Dates:
Date Received: September 27, 2012
Date Started: September 2006
Date Completion: December 2012
Last Updated: October 10, 2012
Last Verified: October 2012