Overview

This trial has been completed.

Condition schizophrenia
Treatments cognitive behavioral social skills training (cbsst), assertive community treatment (act)
Sponsor Veterans Medical Research Foundation
Collaborator National Institute of Mental Health (NIMH)
Start date February 2012
End date August 2016
Trial size 178 participants
Trial identifier NCT02254733, 5R01MH091057

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Implementing Cognitive Behavioral Social Skills Training in an Assertive Community Treatment model
cognitive behavioral social skills training (cbsst) CBT
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)
Assertive Community Treatment only
assertive community treatment (act) 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.

Primary Outcomes

Measure
Independent Living Skills Survey (ILSS)
time frame: Baseline, 18 mos.

Secondary Outcomes

Measure
Expanded Brief Psychiatric Rating Scale (BPRS) - Positive symptom factor structure
time frame: Baseline, 18 mos.
Scale for Assessment of Negative Symptoms (SANS)
time frame: Baseline, 18 mos.
Defeatist Performance Attitude Scale (DPAS)
time frame: Baseline, 18 mos.
Maryland Assessment of Social Competence (MASC)
time frame: Baseline, 18 mos.
Comprehensive Modules Test (CMT)
time frame: Baseline, 18 mos.
Cognitive Therapy Scale for Psychosis (CTS-Psy)
time frame: Baseline, 18 mos
Dartmouth Assertive Community Treatment Scale (DACTS)
time frame: Baseline, 18 mos

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Enhancing Assertive Community Treatment With Cognitive Behavioral Therapy and Social Skills Training for Schizophrenia.
Principal investigator Eric Granholm, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Veterans Medical Research Foundation.