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SchizophreniaNCT02254733

Assertive Community Treatment With CBT and SST for Schizophrenia

A study testing Cognitive Behavioral Social Skills Training (CBSST) and Assertive Community Treatment (ACT) in people with Schizophrenia, run by Veterans Medical Research Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
Cognitive Behavioral Social Skills Training (CBSST) and Assertive Community Treatment (ACT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
1 siteUnited States
Study dates
Feb 2012to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA San Diego Healthcare System

    San Diego, California, 92161

Other trials in United States

About this study

Official title: Enhancing Assertive Community Treatment With Cognitive Behavioral Therapy and Social Skills Training 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.

Read the 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.

Conditions
Schizophrenia
Being tested
Cognitive Behavioral Social Skills Training (CBSST), Assertive Community Treatment (ACT)
Keywords
CBSST, Schizoaffective Disorder, Psychotic Disorder, Cognitive Behavioral Therapy, Social Skills Training, Assertive Community Treatment
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Social Skills Training (CBSST)Behavioural

    Also called CBT, SST

    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).

  • Assertive Community Treatment (ACT)Other

    Also called 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.

Study groups in NCT02254733
Study groupRoleWhat they receive
ACT + CBSSTExperimentalImplementing Cognitive Behavioral Social Skills Training in an Assertive Community Treatment model
Receives: Behavioral: Cognitive Behavioral Social Skills Training (CBSST)
ACT onlyActive comparatorAssertive Community Treatment only
Receives: Other: Assertive Community Treatment (ACT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 18 mos.

Secondary outcomes (7)

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

    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.

    Measured: Baseline, 18 mos.

  2. Scale for Assessment of Negative Symptoms (SANS)

    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)

    Measured: Baseline, 18 mos.

  3. Defeatist Performance Attitude Scale (DPAS)

    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.

    Measured: Baseline, 18 mos.

  4. Maryland Assessment of Social Competence (MASC)

    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.

    Measured: Baseline, 18 mos.

  5. Comprehensive Modules Test (CMT)

    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.

    Measured: Baseline, 18 mos.

  6. Cognitive Therapy Scale for Psychosis (CTS-Psy)

    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.

    Measured: Baseline, 18 mos

  7. Dartmouth Assertive Community Treatment Scale (DACTS)

    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.

    Measured: Baseline, 18 mos

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2014 (estimated)
  2. Study startFeb 2012
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02254733
Sponsor's protocol ID
5R01MH091057
Other IDs
5R01MH091057
Status last verified
Nov 2016
First submitted
25 Apr 2014
Last updated
17 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 17962231

  • 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.

    PubMed 18540742

  • 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.

    PubMed 15741469

  • 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.

    PubMed 17503982

  • 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.

    PubMed 19762654

  • 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. 2026 Jan 16;52(1):sbaf103. doi: 10.1093/schbul/sbaf103.

    PubMed 41391109

  • 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. 2026 Jan 16;52(1):sbaf084. doi: 10.1093/schbul/sbaf084.

    PubMed 41391103

  • 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.

    PubMed 30406858

  • 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.

    PubMed 26424639

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Social Skills Training (CBSST) and Assertive Community Treatment (ACT) in people with Schizophrenia, run by Veterans Medical Research Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Independent Living Skills Survey (ILSS) (time frame: Baseline, 18 mos.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02254733, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2016.

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