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Assertive Community Treatment With CBT and SST for Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Social Skills Training (CBSST)
Assertive Community Treatment (ACT)
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring CBSST, Schizoaffective Disorder, Psychotic Disorder, Cognitive Behavioral Therapy, Social Skills Training, Assertive Community Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • VA San Diego Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACT + CBSST

ACT only

Arm Description

Implementing Cognitive Behavioral Social Skills Training in an Assertive Community Treatment model

Assertive Community Treatment only

Outcomes

Primary Outcome Measures

Independent Living Skills Survey (ILSS)
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

Expanded Brief Psychiatric Rating Scale (BPRS) - Positive symptom factor structure
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)
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)
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)
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)
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)
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)
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.

Full Information

First Posted
April 25, 2014
Last Updated
November 16, 2016
Sponsor
Veterans Medical Research Foundation
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02254733
Brief Title
Assertive Community Treatment With CBT and SST for Schizophrenia
Official Title
Enhancing Assertive Community Treatment With Cognitive Behavioral Therapy and Social Skills Training for Schizophrenia.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
CBSST, Schizoaffective Disorder, Psychotic Disorder, Cognitive Behavioral Therapy, Social Skills Training, Assertive Community Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT + CBSST
Arm Type
Experimental
Arm Description
Implementing Cognitive Behavioral Social Skills Training in an Assertive Community Treatment model
Arm Title
ACT only
Arm Type
Active Comparator
Arm Description
Assertive Community Treatment only
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Social Skills Training (CBSST)
Other Intervention Name(s)
CBT, SST
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Assertive Community Treatment (ACT)
Other Intervention Name(s)
ACT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Independent Living Skills Survey (ILSS)
Description
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.
Time Frame
Baseline, 18 mos.
Secondary Outcome Measure Information:
Title
Expanded Brief Psychiatric Rating Scale (BPRS) - Positive symptom factor structure
Description
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.
Time Frame
Baseline, 18 mos.
Title
Scale for Assessment of Negative Symptoms (SANS)
Description
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)
Time Frame
Baseline, 18 mos.
Title
Defeatist Performance Attitude Scale (DPAS)
Description
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.
Time Frame
Baseline, 18 mos.
Title
Maryland Assessment of Social Competence (MASC)
Description
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.
Time Frame
Baseline, 18 mos.
Title
Comprehensive Modules Test (CMT)
Description
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.
Time Frame
Baseline, 18 mos.
Title
Cognitive Therapy Scale for Psychosis (CTS-Psy)
Description
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.
Time Frame
Baseline, 18 mos
Title
Dartmouth Assertive Community Treatment Scale (DACTS)
Description
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.
Time Frame
Baseline, 18 mos

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Granholm, PhD
Organizational Affiliation
San Diego Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17962231
Citation
Wykes T, Steel C, Everitt B, Tarrier N. Cognitive behavior therapy for schizophrenia: effect sizes, clinical models, and methodological rigor. Schizophr Bull. 2008 May;34(3):523-37. doi: 10.1093/schbul/sbm114. Epub 2007 Oct 25.
Results Reference
background
PubMed Identifier
18540742
Citation
Kurtz MM, Mueser KT. A meta-analysis of controlled research on social skills training for schizophrenia. J Consult Clin Psychol. 2008 Jun;76(3):491-504. doi: 10.1037/0022-006X.76.3.491.
Results Reference
background
PubMed Identifier
15741469
Citation
Granholm E, McQuaid JR, McClure FS, Auslander LA, Perivoliotis D, Pedrelli P, Patterson T, Jeste DV. A randomized, controlled trial of cognitive behavioral social skills training for middle-aged and older outpatients with chronic schizophrenia. Am J Psychiatry. 2005 Mar;162(3):520-9. doi: 10.1176/appi.ajp.162.3.520.
Results Reference
background
PubMed Identifier
17503982
Citation
Granholm E, McQuaid JR, McClure FS, Link PC, Perivoliotis D, Gottlieb JD, Patterson TL, Jeste DV. Randomized controlled trial of cognitive behavioral social skills training for older people with schizophrenia: 12-month follow-up. J Clin Psychiatry. 2007 May;68(5):730-7. doi: 10.4088/jcp.v68n0510.
Results Reference
background
PubMed Identifier
19762654
Citation
Aarons GA, Wells RS, Zagursky K, Fettes DL, Palinkas LA. Implementing evidence-based practice in community mental health agencies: a multiple stakeholder analysis. Am J Public Health. 2009 Nov;99(11):2087-95. doi: 10.2105/AJPH.2009.161711. Epub 2009 Sep 17.
Results Reference
background
PubMed Identifier
30406858
Citation
Sommerfeld DH, Aarons GA, Naqvi JB, Holden J, Perivoliotis D, Mueser KT, Granholm E. Stakeholder Perspectives on Implementing Cognitive Behavioral Social Skills Training on Assertive Community Treatment Teams. Adm Policy Ment Health. 2019 Mar;46(2):188-199. doi: 10.1007/s10488-018-0904-8.
Results Reference
derived
PubMed Identifier
26424639
Citation
Granholm E, Holden JL, Sommerfeld D, Rufener C, Perivoliotis D, Mueser K, Aarons GA. Enhancing assertive community treatment with cognitive behavioral social skills training for schizophrenia: study protocol for a randomized controlled trial. Trials. 2015 Sep 30;16:438. doi: 10.1186/s13063-015-0967-8.
Results Reference
derived

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Assertive Community Treatment With CBT and SST for Schizophrenia

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