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Assertive Community Treatment With CBT and SST for Schizophrenia

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ClinicalTrials.gov Identifier: NCT02254733
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : November 17, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Veterans Medical Research Foundation

Study Description
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Brief Summary:
This project is an effectiveness trial comparing two psychosocial treatments for schizophrenia: Assertive Community Treatment (ACT) + Cognitive Behavioral Social Skills Training (CBSST) v. ACT, alone.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Cognitive Behavioral Social Skills Training (CBSST) Other: Assertive Community Treatment (ACT) Not Applicable

Detailed Description:
Assertive community treatment (ACT) is one of the most well-validated treatment models for people with severe mental illness, and ACT is one of the few evidence-based practices that is widely implemented in community mental health programs; however, existing ACT approaches have little impact on functioning. The ACT model provides a unique opportunity for implementation of recovery-oriented EBPs throughout community mental health programs in the US. This project will examine the incremental effectiveness of implementing cognitive-behavioral strategies and social skills training in ACT relative to ACT, alone. The investigators will begin to examine a potential mechanism of change involving defeatist performance beliefs that can interfere with performance of community functioning behaviors, and will use qualitative methods to identify barriers and factors that contribute to successful implementation.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Enhancing Assertive Community Treatment With Cognitive Behavioral Therapy and Social Skills Training for Schizophrenia.
Study Start Date : February 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: ACT + CBSST
Implementing Cognitive Behavioral Social Skills Training in an Assertive Community Treatment model
 Behavioral: Cognitive Behavioral Social Skills Training (CBSST)
CBSST integrates CBT and SST techniques and neurocognitive compensatory aids. The treatment manual includes a patient workbook that describes the skills and includes homework assignment forms. Cognitive therapy is combined with role play practice of communication skills and problem-solving training. The ACT-adapted, team-delivered individual CBSST intervention will be delivered in 3 6-session modules (Cognitive Skills, Social Skills, and Problem Solving Skills) for a total of 18 weekly individual therapy sessions, but with participants completing the sequence of 3 modules twice, for a total of 36 sessions (9 months).
Other Names:
  • CBT
  • SST
Active Comparator: ACT only
Assertive Community Treatment only
 Other: Assertive Community Treatment (ACT)
Assertive Community Treatment model is a evidence based practice model. ACT teams are multi-disciplinary and provide comprehensive services to individuals in their natural setting with small staff to recipient ratio. ACT teams use assertive engagement to proactively engage individuals in treatment providing services and support directly to individuals that are tailored to meet their specific goals and needs.
Other Name: ACT


Outcome Measures
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Primary Outcome Measures :
  1. Independent Living Skills Survey (ILSS) [ Time Frame: Baseline, 18 mos. ]
    The ILSS is 70 item self-report measure in an interview format to assess everyday functioning. Each item is rated from 0 (No) to 1 (Yes). Scales are summed to yield a total score. Higher scores represent a higher level of functioning.


Secondary Outcome Measures :
  1. Expanded Brief Psychiatric Rating Scale (BPRS) - Positive symptom factor structure [ Time Frame: Baseline, 18 mos. ]
    The expanded BPRS is a 24-item scale that measures psychiatric symptom severity. Each item is rated from 1 (not reported) to 7 (very severe). Items are summed to yield a total factor score. Higher scores represent higher positive symptom severity.

  2. Scale for Assessment of Negative Symptoms (SANS) [ Time Frame: Baseline, 18 mos. ]
    The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. The first 13 items measure diminished expression which consists of two domains: Affective flattening and Alogia. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #8 and #13)

  3. Defeatist Performance Attitude Scale (DPAS) [ Time Frame: Baseline, 18 mos. ]
    The DPAS is a 15-item self-report subscale of the commonly-used 40-item Dysfunctional Attitude Scale (DAS) used to measure generalized defeatist beliefs about one's ability to perform tasks and effectiveness of social behaviors. Each item is rated from 1 (agree completely) to 7 (disagree completely). Higher total scores (range = 15-105) indicate more severe defeatist performance attitudes.

  4. Maryland Assessment of Social Competence (MASC) [ Time Frame: Baseline, 18 mos. ]
    The MASC is a structured behavioral role play assessment that measures the ability to resolve interpersonal problems through conversation in three role play scenarios. Videotaped role plays are rated by blinded raters on three dimensions; verbal content, nonverbal communication behavior, and overall effectiveness, which will be the primary MASC variable. Each item is rated from 1 (very poor) to 5 (very good). A higher score for that dimension reflects higher ability and skills to solve problems in an interpersonal context.

  5. Comprehensive Modules Test (CMT) [ Time Frame: Baseline, 18 mos. ]
    The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition. Scores are summed to yield a total CMT score range from 0-33. Higher total scores represent higher level of CBSST skills acquisition.

  6. Cognitive Therapy Scale for Psychosis (CTS-Psy) [ Time Frame: Baseline, 18 mos ]
    The Cognitive Therapy Scale for Psychosis (CTS-Psy) is 10 item scale for assessing the quality of cognitive behavior therapy. Items are scored on a scale from 0 to 6, where the total maximum achievable is 60. Higher scores indicate greater level of competency.

  7. Dartmouth Assertive Community Treatment Scale (DACTS) [ Time Frame: Baseline, 18 mos ]
    The DACTS is an assessment of assertive community treatment service fidelity. It consists of 28 items, each rated on a behaviorally-anchored scale from 1(not implemented) to 5 (fully implemented). The mean score for the total scale will be used as the measure of ACT team fidelity. A DACTS score of >4.0 is considered moderately high fidelity.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV-diagnosis of schizophrenia or schizoaffective disorder at any stage of illness

Exclusion Criteria:

  • Unstable assignment (at least 3 months) to an ACT team;
  • Prior exposure to SST or CBT in the past 5 years
  • Level of care required interferes with outpatient therapy (e.g., current hospitalization for psychiatric, substance use or physical illness).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254733


Locations
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United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Eric Granholm, PhD San Diego Veterans Healthcare System
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02254733     History of Changes
Other Study ID Numbers: 5R01MH091057 ( U.S. NIH Grant/Contract )
5R01MH091057 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Veterans Medical Research Foundation:
CBSST
Schizoaffective Disorder
Psychotic Disorder
 Cognitive Behavioral Therapy
Social Skills Training
Assertive Community Treatment

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders