Improving Negative Symptoms of Psychosis In Real-world Environments

NCT ID: NCT02170051

Last Updated: 2021-05-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-01

Study Completion Date

2018-09-03

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CBSST-CCT

Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training

Group Type EXPERIMENTAL

CBSST-CCT

Intervention Type BEHAVIORAL

Goal-focused supportive contact

Goal-focused supportive contact

Group Type ACTIVE_COMPARATOR

Goal focused supportive contact

Intervention Type BEHAVIORAL

Interventions

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CBSST-CCT

Intervention Type BEHAVIORAL

Goal focused supportive contact

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training

Eligibility Criteria

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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) .
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Twamley

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Twamley, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Eric Granholm, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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UCSD

La Jolla, California, United States

Site Status

Countries

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United States

References

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Granholm E, Twamley EW, Mahmood Z, Keller AV, Lykins HC, Parrish EM, Thomas ML, Perivoliotis D, Holden JL. Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training for Negative Symptoms of Psychosis: Effects in a Pilot Randomized Controlled Trial. Schizophr Bull. 2022 Mar 1;48(2):359-370. doi: 10.1093/schbul/sbab126.

Reference Type DERIVED
PMID: 34665853 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R34MH101250

Identifier Type: NIH

Identifier Source: secondary_id

View Link

130424

Identifier Type: -

Identifier Source: org_study_id

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