Cognitive Behavioral Therapy for Paranoia in Schizophrenia

Paranoid Delusions Clinical Trial

— CBTp  

Official title:

Cognitive Behavioral Therapy for Paranoia in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704833
• Other study ID #: 0505007908
• Status: Completed
• Phase: N/A
• Start date: September 2006
• Est. completion date: June 2017

Study information

• Verified date: December 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2017
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Delusions
• Paranoid Delusions
• Schizophrenia

Intervention

Behavioral:
• Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)
The PFCBT is a 15-week Program that includes weekly group and individual sessions.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Working Alliance Inventory (WAI)	Used to assess the participants' perceived alliance to the therapist.	Measured at week 16 (post CBT).
Other	The Empathy Scale (ES)	Measures participants' perceptions of the therapist's warmth, genuineness, and empathy.	Measured at week 16 (post CBT).
Other	Group Cohesiveness Scale (GCS)	Measures group cohesiveness.	Measured at week 16 (post CBT).
Other	Changes from Baseline in Brain Circuitry at week 42.	'Linguistic threat' fMRI paradigm is used to monitor brain circuitry changes associated with PFCBT.	Measured at baseline and at week 42.
Primary	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	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.
Secondary	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.
Secondary	Change from Baseline in Cognitive Insight at week 16.	Beck Cognitive Insight Scale. Measures cognitive insight.	Measured at baseline and at week 16.
Secondary	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.