N/A
N=55
Improving Negative Symptoms of Psychosis In Real-world Environments
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02170051 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Clinical Assessment Interview for Negative Symptoms (CAINS) — .0667; -.0588 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CBSST-CCT (Behavioral); Goal focused supportive contact (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Assessment Interview for Negative Symptoms (CAINS) |
.0667; -.0588 | — |
| SECONDARY MATRICS Consensus Cognitive Battery (MCCB) |
.8778; -.0065 | — |
| SECONDARY UCSD Performance-based Skills Assessment-Brief (UPSA-B) |
3.1667; 1.3882 | — |
| SECONDARY Social Skills Performance Assessment (SSPA) |
.1824; .0548 | — |
| SECONDARY Specific Levels of Functioning Scale (SLOF) |
.1718; .2498 | — |
| SECONDARY Independent Living Skills Survey (ILSS) |
.0121; -.0078 | — |
| SECONDARY Defeatist Performance Attitudes Scale (DPAS) |
-3.8667; 1.1765 | — |
| SECONDARY Scale for the Assessment of Negative Symptoms (SANS) |
-.8000; -.1176 | — |
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.
Eligibility Criteria
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) .
Data sourced from ClinicalTrials.gov (NCT02170051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.