Improving Negative Symptoms of Psychosis In Real-world Environments

Study Overview
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Brief Summary
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This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention better improves symptoms and functioning in people with schizophrenia.

Official Title
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Improving Negative Symptoms of Psychosis In Real-world Environments

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: CBSST-CCT
* Behavioral: Goal focused supportive contact


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MUST BE A RESIDENT OF BROADWAY HOME, SAN DIEGO, OR A SERVICE USER OF THE MEETING PLACE, ARETA CROWELL, OR PROJECT ENABLE. Voluntary informed consent to participate Age 18 to 65 DSM-IV diagnosis of schizophrenia or schizoaffective disorder based on MINI/SCID Moderate-to-severe negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS total score >19) ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual) Stable on medications; no changes within 3 months prior to enrollment Exclusion Criteria: Prior CBT, SST, or CCT in the past 5 years Severe positive symptoms on the Positive and Negative Syndrome Scale (PANSS Delusions, Disorganization, Hallucinations, or Suspiciousness >5) Severe depression on the Calgary Depression Scale for Schizophrenia (CDSS >8) Ocular damage/disease/surgery/medications that affect pupil dilation DSM-IV alcohol or substance dependence diagnosis in past 6 months based on the MINI or SCID Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness) .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBSST-CCT<br>Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training | Behavioral: CBSST-CCT<br> <br> * Other names: Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training;|
| Active Comparator: Goal-focused supportive contact<br>Goal-focused supportive contact | Behavioral: Goal focused supportive contact<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Assessment Interview for Negative Symptoms (CAINS) | Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity. | baseline, 12.5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MATRICS Consensus Cognitive Battery (MCCB) | Change in cognitive performance in several domains at 12.5 weeks. Scores range from 0-80; higher scores indicate better performance. | baseline, 12.5 weeks | 
| UCSD Performance-based Skills Assessment-Brief (UPSA-B) | Change in communication and financial functioning at 12.5 weeks. Scores range from 0-100; higher scores indicate better performance. | baseline, 12.5 weeks | 
| Social Skills Performance Assessment (SSPA) | Change in social skills performance at 12.5 weeks. Scores range from 2-10; higher scores indicate better social skills. | baseline, 12.5 weeks | 
| Specific Levels of Functioning Scale (SLOF) | Change in self-reported functioning at 12.5 weeks. Scores range from 30-150. Higher score indicates better functioning. | baseline, 12.5 weeks | 
| Independent Living Skills Survey (ILSS) | Change in self-reported functioning at 12.5 weeks. Scores range from 0-1; higher score indicates better skills. | baseline, 12.5 weeks | 
| Defeatist Performance Attitudes Scale (DPAS) | Change in defeatist attitudes at 12.5 weeks. Likert Scale 1-7; scores range from 15-105; higher scores indicate a more severe defeatist performance attitude. | baseline, 12.5 weeks | 
| Scale for the Assessment of Negative Symptoms (SANS) | Change in negative symptom severity at 12.5 weeks. Scores range from 0-25; higher values indicate greater severity. | baseline, 12.5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognition, defeatist attitudes, negative symptoms, functioning, psychosocial treatment