Overview

This trial is active, not recruiting.

Condition paranoid delusions
Treatment paranoia-focused cognitive behavioral therapy (pfcbt)
Sponsor Weill Medical College of Cornell University
Collaborator National Alliance for Research on Schizophrenia and Depression
Start date September 2006
End date September 2009
Trial size 24 participants
Trial identifier NCT01704833, 0505007908

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care.
paranoia-focused cognitive behavioral therapy (pfcbt)
The PFCBT is a 15-week Program that includes weekly group and individual sessions.
(No Intervention)
This group receives standard care only.

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
Change from Baseline in Attributional Style at week 16.
time frame: Measured at baseline and at week 16.
Change from Baseline in a Tendency to Jump to Conclusions at week 16.
time frame: Measured at baseline and at week 16.
Change from Baseline in Cognitive Insight at week 16.
time frame: Measured at baseline and at week 16.
Change from Baseline in Dimensions of Paranoid Delusions
time frame: Measured at baseline, at week 16 and at week 42.

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Cognitive Behavioral Therapy for Paranoia in Schizophrenia
Principal investigator Yulia Landa, Psy D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.