Improving Negative Symptoms of Psychosis In Real-world Environments (INSPIRE)

April 29, 2021 updated by: Elizabeth Twamley, University of California, San Diego
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UCSD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBSST-CCT
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
Behavioral: CBSST-CCT
Other Names:
  • Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
Active Comparator: Goal-focused supportive contact
Behavioral: Goal focused supportive contact

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 12.5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 12.5 weeks
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.
baseline, 12.5 weeks
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.
baseline, 12.5 weeks
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.
baseline, 12.5 weeks
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.
baseline, 12.5 weeks
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.
baseline, 12.5 weeks
Scale for the Assessment of Negative Symptoms (SANS)
Time Frame: baseline, 12.5 weeks
Change in negative symptom severity at 12.5 weeks. Scores range from 0-25; higher values indicate greater severity.
baseline, 12.5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Elizabeth Twamley, PhD, UCSD
  • Principal Investigator: Eric Granholm, PhD, UCSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

September 3, 2018

Study Completion (Actual)

September 3, 2018

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130424
  • 1R34MH101250 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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