Paranoid Delusions
Conditions
Keywords
Psychosis, Paranoia, Cognitive Behavioral Therapy, Delusions, Group Therapy
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.
Interventions
BEHAVIORALParanoia-Focused Cognitive Behavioral Therapy (PFCBT)
The PFCBT is a 15-week Program that includes weekly group and individual sessions.
Sponsors
National Alliance for Research on Schizophrenia and Depression
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| The Working Alliance Inventory (WAI) | Measured at week 16 (post CBT). | Used to assess the participants' perceived alliance to the therapist. |
Countries
United States
Outcome results
None listed