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Completed

NCT Number: NCT02254733

Assertive Community Treatment With CBT and SST for Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cognitive Behavioral Social Skills Training (CBSST)

Behavioral

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

Assertive Community Treatment (ACT)

Other

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 names: ACT

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Enhancing Assertive Community Treatment With Cognitive Behavioral Therapy and Social Skills Training for Schizophrenia.

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 2, 2014
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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