Improving Negative Symptoms of Psychosis In Real-world Environments

Schizophrenia Clinical Trial

— INSPIRE  

Official title:

Improving Negative Symptoms of Psychosis In Real-world Environments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170051
• Other study ID #: 130424
• Secondary ID: 1R34MH101250
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: September 3, 2018

Study information

• Verified date: April 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 3, 2018
• Est. primary completion date: September 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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) .

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• CBSST-CCT

• Goal focused supportive contact

Locations

Country	Name	City	State
United States	UCSD	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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