CBTp: Cognitive Behavioral Therapy for Paranoia in Schizophrenia

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT01704833

Collaborator

National Alliance for Research on Schizophrenia and Depression (Other)

Enrollment

Location

Arms

129

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Paranoid Delusions	Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Cognitive Behavioral Therapy for Paranoia in Schizophrenia

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from Baseline in Persecution Severity at week 16 and at week 42. [Measured at baseline, 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. [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).
Change from Baseline in a Tendency to Jump to Conclusions at week 16. [Measured at baseline and 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. [Measured at baseline and at week 16.]
Beck Cognitive Insight Scale. Measures cognitive insight.
Change from Baseline in Dimensions of Paranoid Delusions [Measured at baseline, at week 16 and at week 42.]
Psychotic Symptom Rating Scales (PSYRATS), Delusions. Measure dimensions of delusions.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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