Improving Negative Symptoms of Psychosis In Real-world Environments (INSPIRE)
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ClinicalTrials.gov Identifier: NCT02170051 |
Recruitment Status :
Completed
First Posted : June 23, 2014
Results First Posted : November 27, 2020
Last Update Posted : November 27, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Behavioral: CBSST-CCT Behavioral: Goal focused supportive contact | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Improving Negative Symptoms of Psychosis In Real-world Environments |
Actual Study Start Date : | July 1, 2014 |
Actual Primary Completion Date : | September 3, 2018 |
Actual Study Completion Date : | September 3, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: CBSST-CCT
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
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Behavioral: CBSST-CCT
Other Name: Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training |
Active Comparator: Goal-focused supportive contact
Goal-focused supportive contact
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Behavioral: Goal focused supportive contact |
- Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: baseline, 12.5 weeks ]Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity.
- MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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) .

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170051
United States, California | |
UCSD | |
La Jolla, California, United States, 92093 |
Principal Investigator: | Elizabeth Twamley, PhD | UCSD | |
Principal Investigator: | Eric Granholm, PhD | UCSD |
Documents provided by Elizabeth Twamley, University of California, San Diego:
Responsible Party: | Elizabeth Twamley, Professor of Psychiatry, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT02170051 |
Other Study ID Numbers: |
130424 1R34MH101250 ( U.S. NIH Grant/Contract ) |
First Posted: | June 23, 2014 Key Record Dates |
Results First Posted: | November 27, 2020 |
Last Update Posted: | November 27, 2020 |
Last Verified: | November 2020 |
negative symptoms cognition functioning defeatist attitudes psychosocial treatment |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |