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Completed

NCT Number: NCT02170051

Improving Negative Symptoms of Psychosis In Real-world Environments

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

MUST BE A RESIDENT OF BROADWAY HOME, SAN DIEGO, OR A SERVICE USER OF THE MEETING PLACE, ARETA CROWELL, OR PROJECT ENABLE.

  • Voluntary informed consent to participate
  • Age 18 to 65
  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder based on MINI/SCID
  • Moderate-to-severe negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS total score >19)
  • ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual)
  • Stable on medications; no changes within 3 months prior to enrollment

Exclusion criteria

  • Prior CBT, SST, or CCT in the past 5 years
  • Severe positive symptoms on the Positive and Negative Syndrome Scale (PANSS Delusions, Disorganization, Hallucinations, or Suspiciousness >5)
  • Severe depression on the Calgary Depression Scale for Schizophrenia (CDSS >8)
  • Ocular damage/disease/surgery/medications that affect pupil dilation
  • DSM-IV alcohol or substance dependence diagnosis in past 6 months based on the MINI or SCID
  • Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness) .

Treatment and study plan

CBSST-CCT

Behavioral

Other names: Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training

Goal focused supportive contact

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: INSPIRE

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2014
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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