NCT02254733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

4.5 years

First QC Date

April 25, 2014

Last Update Submit

November 16, 2016

Conditions

Schizophrenia

Keywords

CBSSTSchizoaffective DisorderPsychotic DisorderCognitive Behavioral TherapySocial Skills TrainingAssertive Community Treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 18 mos.

Secondary Outcomes (7)

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

    Baseline, 18 mos.

  • Scale for Assessment of Negative Symptoms (SANS)

    Baseline, 18 mos.

  • Defeatist Performance Attitude Scale (DPAS)

    Baseline, 18 mos.

  • Maryland Assessment of Social Competence (MASC)

    Baseline, 18 mos.

  • Comprehensive Modules Test (CMT)

    Baseline, 18 mos.

  • +2 more secondary outcomes

Study Arms (2)

ACT + CBSST

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Social Skills Training (CBSST)

ACT only

ACTIVE COMPARATOR

Assertive Community Treatment only

Other: Assertive Community Treatment (ACT)

Interventions

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).

Also known as: CBT, SST
ACT + CBSST
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.

Also known as: ACT
ACT only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV-diagnosis of schizophrenia or schizoaffective disorder at any stage of illness

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (9)

  • 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.

    PMID: 17962231BACKGROUND

  • 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.

    PMID: 18540742BACKGROUND

  • 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.

    PMID: 15741469BACKGROUND

  • 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.

    PMID: 17503982BACKGROUND

  • 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.

    PMID: 19762654BACKGROUND

  • Pillny M, Mueser KT, Holden J, Aarons GA, Sommerfeld D, Perivoliotis D, Granholm E. Enhancing Assertive Community Treatment With Cognitive Behavioral Social Skills Training for Schizophrenia: II. Ecological Momentary Assessment Outcomes in a Pragmatic Randomized-Controlled Trial. Schizophr Bull. 2025 Dec 14:sbaf103. doi: 10.1093/schbul/sbaf103. Online ahead of print.

    PMID: 41391109DERIVED

  • Granholm E, Mueser KT, Holden JL, Worley M, Sommerfeld D, Perivoliotis D, Ehret B, Pillny M, Aarons GA. Enhancing Assertive Community Treatment with Cognitive Behavioral Social Skills Training for Schizophrenia: I. Primary Outcomes in a Pragmatic Randomized-Controlled Trial. Schizophr Bull. 2025 Dec 14:sbaf084. doi: 10.1093/schbul/sbaf084. Online ahead of print.

    PMID: 41391103DERIVED

  • 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.

    PMID: 30406858DERIVED

  • 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.

    PMID: 26424639DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Community Mental Health Services

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Eric Granholm, PhD

    San Diego Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2014

First Posted

October 2, 2014

Study Start

February 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)