Cognitive Behavioral Therapy for Paranoia in Schizophrenia (CBTp)

December 3, 2018 updated by: Weill Medical College of Cornell University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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).
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.
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.
Time Frame: Measured at baseline and 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
Time Frame: Measured at baseline, at week 16 and at week 42.
Psychotic Symptom Rating Scales (PSYRATS), Delusions. Measure dimensions of delusions.
Measured at baseline, at week 16 and at week 42.

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Alliance for Research on Schizophrenia and Depression

Investigators

  • Principal Investigator: Yulia Landa, Psy D., Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0505007908

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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