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

University of California San Diego logo

University of California San Diego

Status

Completed

Conditions

Schizophrenia

Treatments

Behavioral: Goal focused supportive contact
Behavioral: CBSST-CCT

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02170051
130424
1R34MH101250 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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) .

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

CBSST-CCT
Experimental group
Description:
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
Treatment:
Behavioral: CBSST-CCT
Goal-focused supportive contact
Active Comparator group
Description:
Goal-focused supportive contact
Treatment:
Behavioral: Goal focused supportive contact

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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