An interventional study of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in Paranoid Delusions, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-04.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
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.
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.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
This study's enrollment of 24 is below the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
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Exclusion Criteria:
-Substance misuse or medical disorder identified as the primary cause of delusions
This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care.
Behavioral: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)
This group receives standard care only.
The PFCBT is a 15-week Program that includes weekly group and individual sessions.
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).
Time frame: Measured at baseline, at week 16, and at week 42.
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).
Time frame: Measured at baseline and at week 16.
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.
Time frame: Measured at baseline and at week 16.
Change from Baseline in Cognitive Insight at week 16.
Beck Cognitive Insight Scale. Measures cognitive insight.
Time frame: Measured at baseline and at week 16.
Change from Baseline in Dimensions of Paranoid Delusions
Psychotic Symptom Rating Scales (PSYRATS), Delusions. Measure dimensions of delusions.
Time frame: Measured at baseline, at week 16 and at week 42.
The Working Alliance Inventory (WAI)
Used to assess the participants' perceived alliance to the therapist.
Time frame: Measured at week 16 (post CBT).
The Empathy Scale (ES)
Measures participants' perceptions of the therapist's warmth, genuineness, and empathy.
Time frame: Measured at week 16 (post CBT).
Group Cohesiveness Scale (GCS)
Measures group cohesiveness.
Time frame: Measured at week 16 (post CBT).
Changes from Baseline in Brain Circuitry at week 42.
'Linguistic threat' fMRI paradigm is used to monitor brain circuitry changes associated with PFCBT.
Time frame: Measured at baseline and at week 42.
The record gives a start of Sep 2006, a primary completion of Sep 2009 and a completion of Jun 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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