Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy | Experimental | This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care. |
|
| Treatment as Usual | No Intervention | This group receives standard care only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) | Behavioral | The PFCBT is a 15-week Program that includes weekly group and individual sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Measured at baseline, at week 16, and at week 42. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Measured at baseline and at week 16. |
| Change from Baseline in a Tendency to Jump to Conclusions at week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| The Working Alliance Inventory (WAI) | Used to assess the participants' perceived alliance to the therapist. | Measured at week 16 (post CBT). |
| The Empathy Scale (ES) | Measures participants' perceptions of the therapist's warmth, genuineness, and empathy. |
Inclusion Criteria:
Exclusion Criteria:
-Substance misuse or medical disorder identified as the primary cause of delusions
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yulia Landa, Psy D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10065 | United States |
Not provided
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D010259 | Paranoid Disorders |
| D003702 | Delusions |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measured by the BEADS Task. Measures a tendency to jump to conclusions when making a judgment. |
| Measured at baseline and at week 16. |
| Change from Baseline in Cognitive Insight at week 16. | Beck Cognitive Insight Scale. Measures cognitive insight. | 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. | Measured at baseline, at week 16 and at week 42. |
| Measured at week 16 (post CBT). |
| Group Cohesiveness Scale (GCS) | Measures group cohesiveness. | 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. | Measured at baseline and at week 42. |