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
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: Cognitive Behavioral Social Skills Training (CBSST) Other: Assertive Community Treatment (ACT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||178 participants|
|Intervention Model:||Parallel Assignment|
|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|
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).
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
- 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.
- 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.
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
|United States, California|
|VA San Diego Healthcare System|
|San Diego, California, United States, 92161|
|Principal Investigator:||Eric Granholm, PhD||San Diego Veterans Healthcare System|