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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBSST-CCT

Goal focused supportive contact

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring negative symptoms, cognition, functioning, defeatist attitudes, psychosocial treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

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) .

Sites / Locations

UCSD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBSST-CCT

Goal-focused supportive contact

Arm Description

Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training

Goal-focused supportive contact

Outcomes

Primary Outcome Measures

Clinical Assessment Interview for Negative Symptoms (CAINS)

Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity.

Secondary Outcome Measures

MATRICS Consensus Cognitive Battery (MCCB)

Change in cognitive performance in several domains at 12.5 weeks. Scores range from 0-80; higher scores indicate better performance.

UCSD Performance-based Skills Assessment-Brief (UPSA-B)

Change in communication and financial functioning at 12.5 weeks. Scores range from 0-100; higher scores indicate better performance.

Social Skills Performance Assessment (SSPA)

Change in social skills performance at 12.5 weeks. Scores range from 2-10; higher scores indicate better social skills.

Specific Levels of Functioning Scale (SLOF)

Change in self-reported functioning at 12.5 weeks. Scores range from 30-150. Higher score indicates better functioning.

Independent Living Skills Survey (ILSS)

Change in self-reported functioning at 12.5 weeks. Scores range from 0-1; higher score indicates better skills.

Defeatist Performance Attitudes Scale (DPAS)

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.

Scale for the Assessment of Negative Symptoms (SANS)

Change in negative symptom severity at 12.5 weeks. Scores range from 0-25; higher values indicate greater severity.

Full Information

NCT ID

NCT02170051

First Posted

June 18, 2014

Last Updated

April 29, 2021

Sponsor

University of California, San Diego

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT02170051

Brief Title

Improving Negative Symptoms of Psychosis In Real-world Environments

Acronym

INSPIRE

Official Title

Improving Negative Symptoms of Psychosis In Real-world Environments

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

July 1, 2014 (Actual)

Primary Completion Date

September 3, 2018 (Actual)

Study Completion Date

September 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

negative symptoms, cognition, functioning, defeatist attitudes, psychosocial treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBSST-CCT

Arm Type

Experimental

Arm Description

Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training

Arm Title

Goal-focused supportive contact

Arm Type

Active Comparator

Arm Description

Goal-focused supportive contact

Intervention Type

Behavioral

Intervention Name(s)

CBSST-CCT

Other Intervention Name(s)

Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training

Intervention Type

Behavioral

Intervention Name(s)

Goal focused supportive contact

Primary Outcome Measure Information:

Title

Clinical Assessment Interview for Negative Symptoms (CAINS)

Description

Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity.

Time Frame

baseline, 12.5 weeks

Secondary Outcome Measure Information:

Title

MATRICS Consensus Cognitive Battery (MCCB)

Description

Change in cognitive performance in several domains at 12.5 weeks. Scores range from 0-80; higher scores indicate better performance.

Time Frame

baseline, 12.5 weeks

Title

UCSD Performance-based Skills Assessment-Brief (UPSA-B)

Description

Change in communication and financial functioning at 12.5 weeks. Scores range from 0-100; higher scores indicate better performance.

Time Frame

baseline, 12.5 weeks

Title

Social Skills Performance Assessment (SSPA)

Description

Change in social skills performance at 12.5 weeks. Scores range from 2-10; higher scores indicate better social skills.

Time Frame

baseline, 12.5 weeks

Title

Specific Levels of Functioning Scale (SLOF)

Description

Change in self-reported functioning at 12.5 weeks. Scores range from 30-150. Higher score indicates better functioning.

Time Frame

baseline, 12.5 weeks

Title

Independent Living Skills Survey (ILSS)

Description

Change in self-reported functioning at 12.5 weeks. Scores range from 0-1; higher score indicates better skills.

Time Frame

baseline, 12.5 weeks

Title

Defeatist Performance Attitudes Scale (DPAS)

Description

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.

Time Frame

baseline, 12.5 weeks

Title

Scale for the Assessment of Negative Symptoms (SANS)

Description

Change in negative symptom severity at 12.5 weeks. Scores range from 0-25; higher values indicate greater severity.

Time Frame

baseline, 12.5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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. 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) .

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Twamley, PhD

Organizational Affiliation

UCSD

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eric Granholm, PhD

Organizational Affiliation

UCSD

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSD

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34665853

Citation

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.

Results Reference

derived

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Improving Negative Symptoms of Psychosis In Real-world Environments

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