Weill Cornell Medical College
New York, 10065, United States
NCT Number: NCT01704833
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
New York, 10065, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-Substance misuse or medical disorder identified as the primary cause of delusions
The PFCBT is a 15-week Program that includes weekly group and individual sessions.
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).
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).
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.
Time frame: Measured at baseline and at week 16.
Beck Cognitive Insight Scale. Measures cognitive insight.
Time frame: Measured at baseline, at week 16 and at week 42.
Psychotic Symptom Rating Scales (PSYRATS), Delusions. Measure dimensions of delusions.
Time frame: Measured at week 16 (post CBT).
Used to assess the participants' perceived alliance to the therapist.
Time frame: Measured at week 16 (post CBT).
Measures participants' perceptions of the therapist's warmth, genuineness, and empathy.
Time frame: Measured at week 16 (post CBT).
Measures group cohesiveness.
Time frame: Measured at baseline and at week 42.
'Linguistic threat' fMRI paradigm is used to monitor brain circuitry changes associated with PFCBT.
Weill Medical College of Cornell University
Other
Acronym: CBTp
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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