Clinical trial NCT02254733: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: CBSST
Schizoaffective Disorder
Psychotic Disorder
Cognitive Behavioral Therapy
Social Skills Training
Assertive Community Treatment
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-10-02
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Independent Living Skills Survey (ILSS)
timeFrame: Baseline, 18 mos.
Secondary outcomes:
measure: Expanded Brief Psychiatric Rating Scale (BPRS) - Positive symptom factor structure
timeFrame: Baseline, 18 mos.
measure: Scale for Assessment of Negative Symptoms (SANS)
timeFrame: Baseline, 18 mos.
measure: Defeatist Performance Attitude Scale (DPAS)
timeFrame: Baseline, 18 mos.
measure: Maryland Assessment of Social Competence (MASC)
timeFrame: Baseline, 18 mos.
measure: Comprehensive Modules Test (CMT)
timeFrame: Baseline, 18 mos.
measure: Cognitive Therapy Scale for Psychosis (CTS-Psy)
timeFrame: Baseline, 18 mos
measure: Dartmouth Assertive Community Treatment Scale (DACTS)
timeFrame: Baseline, 18 mos
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: San Diego Veterans Healthcare System
name: Eric Granholm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.