Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02170051
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : November 27, 2020
Last Update Posted : May 19, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Elizabeth Twamley, University of California, San Diego

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: CBSST-CCT Behavioral: Goal focused supportive contact Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CBSST-CCT
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
 Behavioral: CBSST-CCT
Other Name: Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
Active Comparator: Goal-focused supportive contact
Goal-focused supportive contact
 Behavioral: Goal focused supportive contact


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  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) .
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, California
UCSD
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Elizabeth Twamley, PhD UCSD
Principal Investigator: Eric Granholm, PhD UCSD
  Study Documents (Full-Text)

Documents provided by Elizabeth Twamley, University of California, San Diego:
Study Protocol and Statistical Analysis Plan  [PDF] October 19, 2018

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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: May 19, 2021
Last Verified: April 2021
Keywords provided by Elizabeth Twamley, University of California, San Diego:
negative symptoms
cognition
functioning
defeatist attitudes
psychosocial treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders