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

• 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: University of California, San Diego
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Elizabeth Twamley, University of California, San Diego

Study Description

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

• 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

Arms and Interventions

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

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

• 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

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

  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

• 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
• 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:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders