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Cognitive Behavioral Therapy for Paranoia in Schizophrenia (CBTp)

Primary Purpose

Paranoid Delusions

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)

About this trial

This is an interventional treatment trial for Paranoid Delusions focused on measuring Psychosis, Paranoia, Cognitive Behavioral Therapy, Delusions, Group Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy

Treatment as Usual

Arm Description

This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care.

This group receives standard care only.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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.

Change from Baseline in Cognitive Insight at week 16.

Beck Cognitive Insight Scale. Measures cognitive insight.

Change from Baseline in Dimensions of Paranoid Delusions

Psychotic Symptom Rating Scales (PSYRATS), Delusions. Measure dimensions of delusions.

Full Information

NCT ID

NCT01704833

First Posted

September 27, 2012

Last Updated

December 3, 2018

Sponsor

Weill Medical College of Cornell University

Collaborators

National Alliance for Research on Schizophrenia and Depression

1. Study Identification

Unique Protocol Identification Number

NCT01704833

Brief Title

Cognitive Behavioral Therapy for Paranoia in Schizophrenia

Acronym

CBTp

Official Title

Cognitive Behavioral Therapy for Paranoia in Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Paranoid Delusions

Keywords

Psychosis, Paranoia, Cognitive Behavioral Therapy, Delusions, Group Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Behavioral Therapy

Arm Type

Experimental

Arm Description

This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care.

Arm Title

Treatment as Usual

Arm Type

No Intervention

Arm Description

This group receives standard care only.

Intervention Type

Behavioral

Intervention Name(s)

Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)

Intervention Description

The PFCBT is a 15-week Program that includes weekly group and individual sessions.

Primary Outcome Measure Information:

Title

Change from Baseline in Persecution Severity at week 16 and at week 42.

Description

Measured by the Persecution sub-scale on Positive and Negative Syndrome Scale (PANSS).

Time Frame

Measured at baseline, at week 16, and at week 42.

Secondary Outcome Measure Information:

Title

Change from Baseline in Attributional Style at week 16.

Description

Internal Personal and Situational Attributions Questionnaire.Measures attributional style (a tendency to attribute cause for negative events to situational or personal causes).

Time Frame

Measured at baseline and at week 16.

Title

Change from Baseline in a Tendency to Jump to Conclusions at week 16.

Description

Measured by the BEADS Task. Measures a tendency to jump to conclusions when making a judgment.

Time Frame

Measured at baseline and at week 16.

Title

Change from Baseline in Cognitive Insight at week 16.

Description

Beck Cognitive Insight Scale. Measures cognitive insight.

Time Frame

Measured at baseline and at week 16.

Title

Change from Baseline in Dimensions of Paranoid Delusions

Description

Psychotic Symptom Rating Scales (PSYRATS), Delusions. Measure dimensions of delusions.

Time Frame

Measured at baseline, at week 16 and at week 42.

Other Pre-specified Outcome Measures:

Title

The Working Alliance Inventory (WAI)

Description

Used to assess the participants' perceived alliance to the therapist.

Time Frame

Measured at week 16 (post CBT).

Title

The Empathy Scale (ES)

Description

Measures participants' perceptions of the therapist's warmth, genuineness, and empathy.

Time Frame

Measured at week 16 (post CBT).

Title

Group Cohesiveness Scale (GCS)

Description

Measures group cohesiveness.

Time Frame

Measured at week 16 (post CBT).

Title

Changes from Baseline in Brain Circuitry at week 42.

Description

'Linguistic threat' fMRI paradigm is used to monitor brain circuitry changes associated with PFCBT.

Time Frame

Measured at baseline and at week 42.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yulia Landa, Psy D.

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Cognitive Behavioral Therapy for Paranoia in Schizophrenia

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