Cognitive Behavioral Therapy for Paranoia in Schizophrenia (CBTp)
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|ClinicalTrials.gov Identifier: NCT01704833|
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : December 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Paranoid Delusions||Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive Behavioral Therapy for Paranoia in Schizophrenia|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||June 2017|
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.
- 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).
- 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).
- 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.
- 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.
- 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.
- The Working Alliance Inventory (WAI) [ Time Frame: Measured at week 16 (post CBT). ]Used to assess the participants' perceived alliance to the therapist.
- The Empathy Scale (ES) [ Time Frame: Measured at week 16 (post CBT). ]Measures participants' perceptions of the therapist's warmth, genuineness, and empathy.
- Group Cohesiveness Scale (GCS) [ Time Frame: Measured at week 16 (post CBT). ]Measures group cohesiveness.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704833
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Yulia Landa, Psy D.||Weill Medical College of Cornell University|