Improving Negative Symptoms of Psychosis In Real-world Environments

Not Applicable

Completed

• Conditions: Schizophrenia

• Registration Number: NCT02170051
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-23
• Study Start: 2014-07-01
• Primary Completion: 2018-09-03
• Study Completion: 2018-09-03
• Results First Submitted: 2020-11-02
• Results First Submitted QC: 2020-11-24
• Results First Posted: 2020-11-27
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

MUST BE A RESIDENT OF BROADWAY HOME, SAN DIEGO, OR A SERVICE USER OF THE MEETING PLACE, ARETA CROWELL, OR PROJECT ENABLE.

1. Voluntary informed consent to participate
2. Age 18 to 65
3. DSM-IV diagnosis of schizophrenia or schizoaffective disorder based on MINI/SCID
4. Moderate-to-severe negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS total score >19)
5. ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual)
6. Stable on medications; no changes within 3 months prior to enrollment

Exclusion Criteria

1. Prior CBT, SST, or CCT in the past 5 years
2. Severe positive symptoms on the Positive and Negative Syndrome Scale (PANSS Delusions, Disorganization, Hallucinations, or Suspiciousness >5)
3. Severe depression on the Calgary Depression Scale for Schizophrenia (CDSS >8)
4. Ocular damage/disease/surgery/medications that affect pupil dilation
5. DSM-IV alcohol or substance dependence diagnosis in past 6 months based on the MINI or SCID
6. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness) .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UCSD; 🇺🇸 La Jolla, California, United States