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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

Tracking Information
First Submitted Date  ICMJE April 25, 2014
First Posted Date  ICMJE October 2, 2014
Last Update Posted Date November 17, 2016
Study Start Date  ICMJE February 2012
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • Change in Independent Living Skills Survey (ILSS) [ Time Frame: Baseline, 18 mos. ]
    self-reported functioning
  • Change in Specific Level of Functioning Scale (SLOF) [ Time Frame: Baseline, 18 mos. ]
    self-reported functioning
  • Change in Interviewer-rated Abbreviated Quality of Life Scale [ Time Frame: Baseline, 18 mos. ]
    subjective and objective aspects of functioning
  • Change in performance-based Maryland Assessment of Social Competence [ Time Frame: Baseline, 18 mos. ]
    functional outcome domains
  • Change in PSR Toolkit [ Time Frame: Baseline, 18 mos. ]
    change in employment, educational activity, residential situation, and financial status
  • Change in Experience Sampling Method (ESM) [ Time Frame: Baseline, 18 mos. ]
    Ambulatory monitoring technique used to collect clinical and environmental information which produces greater ecological validity of observations obtained. ESM is used to improve measurements of rehabilitation outcomes.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2016)
  • 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.
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • Change in Expanded Brief Psychiatric Rating Scale [ Time Frame: Baseline, 18 mos. ]
    psychiatric symptom severity
  • Change in Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: Baseline, 18 mos. ]
    negative symptom severity
  • Change in Scale for Assessment of Negative Symptoms (SANS) [ Time Frame: Baseline, 18 mos. ]
    negative symptom severity
  • Change in Defeatist Performance Attitude Scale (DPAS) [ Time Frame: Baseline, 18 mos. ]
    defeatist attitudes
  • Change in Revised Social Anhedonia Scale (RSAS) [ Time Frame: Baseline, 18 mos ]
    Self-reported measures of social dimension of anhedonia
  • Change in Maryland Assessment of Recovery in Serious Mental Illness (MARS) [ Time Frame: Baseline, 18 mos. ]
    self-reported measures of recovery-oriented domains
  • Change in Digit Span Pupillometry [ Time Frame: Baseline, 18 mos. ]
    exerted effort
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assertive Community Treatment With CBT and SST for Schizophrenia
Official Title  ICMJE Enhancing Assertive Community Treatment With Cognitive Behavioral Therapy and Social Skills Training for Schizophrenia.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: ACT + CBSST
    Implementing Cognitive Behavioral Social Skills Training in an Assertive Community Treatment model
    Intervention: Behavioral: Cognitive Behavioral Social Skills Training (CBSST)
  • Active Comparator: ACT only
    Assertive Community Treatment only
    Intervention: Other: Assertive Community Treatment (ACT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2016)
178
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2014)
176
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02254733
Other Study ID Numbers  ICMJE 5R01MH091057( U.S. NIH Grant/Contract )
5R01MH091057 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Veterans Medical Research Foundation
Study Sponsor  ICMJE Veterans Medical Research Foundation
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Eric Granholm, PhD San Diego Veterans Healthcare System
PRS Account Veterans Medical Research Foundation
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP