Cognitive Behavioral Therapy for Paranoia in Schizophrenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive Behavioral Therapy for Paranoia in Schizophrenia

Conditions
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Paranoid Delusions

Intervention / Treatment
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* Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy<br>This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care. | Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)<br>* The PFCBT is a 15-week Program that includes weekly group and individual sessions.<br>|
| No Intervention: Treatment as Usual<br>This group receives standard care only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Persecution Severity at week 16 and at week 42. | Measured by the Persecution sub-scale on Positive and Negative Syndrome Scale (PANSS). | Measured at baseline, at week 16, and at week 42. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Attributional Style 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). | Measured at baseline and at week 16. | 
| Change from Baseline in a Tendency to Jump to Conclusions at week 16. | Measured by the BEADS Task. Measures a tendency to jump to conclusions when making a judgment. | Measured at baseline and at week 16. | 
| Change from Baseline in Cognitive Insight at week 16. | Beck Cognitive Insight Scale. Measures cognitive insight. | Measured at baseline and at week 16. | 
| Change from Baseline in Dimensions of Paranoid Delusions | Psychotic Symptom Rating Scales (PSYRATS), Delusions. Measure dimensions of delusions. | Measured at baseline, at week 16 and at week 42. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosis, Paranoia, Cognitive Behavioral Therapy, Delusions, Group Therapy