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Cognitive Behavioral Therapy for Paranoia in Schizophrenia (CBTp)

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status

Completed

Conditions

Paranoid Delusions

Treatments

Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)

Study type

Interventional

Funder types

Other

Identifiers

NCT01704833
0505007908

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

24 participants in 2 patient groups

Cognitive Behavioral Therapy
Experimental group
Description:
This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care.
Treatment:
Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)
Treatment as Usual
No Intervention group
Description:
This group receives standard care only.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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