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
Last Update Posted : May 2, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 12, 2018
Actual Study Completion Date : February 12, 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. Change in Clinical Assessment Interview for Negative Symptoms (CAINS) at 4.5 months [ Time Frame: baseline, 4.5 months ]
    Negative symptom severity


Secondary Outcome Measures :
  1. Change in MATRICS Consensus Cognitive Battery (MCCB) at 4.5 months [ Time Frame: baseline, 4.5 months ]
    Cognitive performance in several domains

  2. Change in UCSD Performance-based Skills Assessment-Brief at 4.5 months [ Time Frame: baseline, 4.5 months ]
    Communication and financial functioning

  3. Change in Social Skills Performance Assessment at 4.5 months [ Time Frame: baseline, 4.5 months ]
    social skills performance

  4. Change in Specific Levels of Functioning Scale at 4.5 months [ Time Frame: baseline, 4.5 months ]
    self-reported functioning

  5. Change in Independent Living Skills Survey at 4.5 months [ Time Frame: baseline, 4.5 months ]
    self-reported functioning

  6. Change in Defeatist Performance Attitudes Scale at 4.5 months [ Time Frame: baseline, 4.5 months ]
    defeatist attitudes


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.


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
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
Principal Investigator: Elizabeth Twamley, PhD UCSD
Principal Investigator: Eric Granholm, PhD UCSD
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Elizabeth Twamley, Associate Professor of Psychiatry, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02170051     History of Changes
Other Study ID Numbers: 130424
1R34MH101250 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Keywords provided by Elizabeth Twamley, University of California, San Diego:
negative symptoms
cognition
functioning
defeatist attitudes
psychosocial treatment

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders