Clinical trial NCT01704833: Cognitive Behavioral Therapy for Paranoia in Schizophrenia
Official title: Cognitive Behavioral Therapy for Paranoia in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paranoid Delusions
Keywords: Psychosis
Paranoia
Cognitive Behavioral Therapy
Delusions
Group Therapy
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2012-10-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline in Persecution Severity at week 16 and at week 42.
timeFrame: Measured at baseline, at week 16, and at week 42.
Secondary outcomes:
measure: Change from Baseline in Attributional Style at week 16.
timeFrame: Measured at baseline and at week 16.
measure: Change from Baseline in a Tendency to Jump to Conclusions at week 16.
timeFrame: Measured at baseline and at week 16.
measure: Change from Baseline in Cognitive Insight at week 16.
timeFrame: Measured at baseline and at week 16.
measure: Change from Baseline in Dimensions of Paranoid Delusions
timeFrame: Measured at baseline, at week 16 and at week 42.
Other outcomes:
measure: The Working Alliance Inventory (WAI)
timeFrame: Measured at week 16 (post CBT).
measure: The Empathy Scale (ES)
timeFrame: Measured at week 16 (post CBT).
measure: Group Cohesiveness Scale (GCS)
timeFrame: Measured at week 16 (post CBT).
measure: Changes from Baseline in Brain Circuitry at week 42.
timeFrame: Measured at baseline and at week 42.
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Yulia Landa, Psy D.
role: PRINCIPAL_INVESTIGATOR
References: