Recruiting

Clubhouse Model

Sponsor:

Case Western Reserve University

Code:

NCT07006935

Conditions

Schizophrenia

Schizo Affective Disorder

Schizophreniform Disorders

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness

Usual Community-Based Mental Health Care

Study Details

Brief summary:

The purpose of this study is to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions. The investigators are especially interested in learning whether the Clubhouse Model-a structured, supportive community for individuals with mental illness-has unique benefits compared to standard outpatient mental health services. If participants decide to join, they will be asked to complete a total of six study visits with the research team over the course of your participation. Three of these study visits are at the beginning (baseline) and the remaining three are six months later. Two of the three visits will includes interviews, questionnaires, and thinking and memory tasks (cognitive testing) and one session will be an MRI brain scan, which is a safe and non-invasive imaging procedure. The total time required for each visit will be approximately 90 minutes to two hours. Participants may take breaks as needed.

Conditions

Schizophrenia

Schizo Affective Disorder

Schizophreniform Disorders

Study ID

NCT07006935

Start date

Aug 30, 2026

Status verified date

Apr, 2026

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Jan 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • (1) have a DSM-V diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform confirmed by diagnostic assessment and medical record review
  • (2) between the ages of 18-50
  • (3) stabilized on psychotropic medication as indicated by no changes to the primary psychiatric medication in the last month
  • (4) able to read and speak fluent English at a sixth grade level or higher for purposes of informed consent and cognitive testing
  • For Clubhouse members, they must be a first-time, newly enrolled member

Exclusion Criteria:

  • (1) had previous membership at a Clubhouse (Magnolia or elsewhere)
  • (2) have a current severe substance use disorder
  • (3) have persistent suicidal or homicidal behavior
  • (4) a co-occurring diagnosis of an intellectual or learning disability or neurodevelopment condition (e.g., Autism; based on chart review)
  • (5) had recent psychiatric instability requiring hospitalization in the past month;
  • (6) history of a traumatic brain injury (TBI; based on record review)
  • (7) contraindicators for MRI (e.g., pacemaker, claustrophobia)
  • Participants in the usual care will be excluded if they are a current Clubhouse member or join a Clubhouse during participation in this research

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness

The Clubhouse Model (CM) is a strengths-focused, evidence-based, and comprehensive approach to psychosocial rehabilitation for serious mental illness. The CM uses an intentional community of support to create a safe and holistic setting to practice real-world functioning. The core of the CM is the 'work-ordered day,' a concept where members, as opposed to patients, are integral to and needed for the successful daily operation of the Clubhouse. Members choose a 'work unit' each day of attendance. Most clubhouses have four work units, such as (1) Administration (e.g., database management); (2) Hospitality (e.g., Clubhouse cafe); (3) Membership (e.g., employment programs); and (4) Communications (e.g., newsletter). Other unique aspects include its voluntary and humanistic nature, prioritization of member choice, unrestricted and flexible membership, and the elimination of provider-patient hierarchy. The CM has a sophisticated accreditation process based on 37 international standards.

active comparator: Usual Community-Based Mental Health Care

Usual care includes services typically available in the community at mental health agencies, including case management, Assertive Community Treatment, counseling, peer support services, psychoeducational support groups, family support groups, supported education/employment, permanent supportive housing, and medication management.

Interventions

Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness

The Clubhouse Model (CM) is a strengths-focused, evidence-based, and comprehensive approach to psychosocial rehabilitation for serious mental illness. The CM uses an intentional community of support to create a safe and holistic setting to practice real-world functioning. The core of the CM is the 'work-ordered day,' a concept where members, as opposed to patients, are integral to and needed for the successful daily operation of the Clubhouse. Members choose a 'work unit' each day of attendance. Most clubhouses have four work units, such as (1) Administration (e.g., database management); (2) Hospitality (e.g., Clubhouse cafe); (3) Membership (e.g., employment programs); and (4) Communications (e.g., newsletter). Other unique aspects include its voluntary and humanistic nature, prioritization of member choice, unrestricted and flexible membership, and the elimination of provider-patient hierarchy. The CM has a sophisticated accreditation process based on 37 international standards.

Usual Community-Based Mental Health Care

Usual care includes services typically available in the community at mental health agencies, including case management, Assertive Community Treatment, counseling, peer support services, psychoeducational support groups, family support groups, supported education/employment, permanent supportive housing, and medication management.

Primary outcome measure

  • Change in overall cognitive performance as measured by MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: Baseline and 6 months ]
  • Change in functional outcome as measured by Specific Levels of Functioning Scale (SLOF) [ Time Frame: Baseline and 6 months ]
  • Change in quality of life as measured by World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF) [ Time Frame: Baseline and 6 months ]
  • Change in disability as measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0 [ Time Frame: Baseline and 6 months ]
  • Change in task-based brain activation during functional MRI (fMRI) as measured by the AX-Continuous Performance Task (AX-CPT) [ Time Frame: Baseline and 6 months ]
  • Change in task-based brain activation during functional MRI (fMRI) as measured by the Emotional Faces N-Based Task (EFNBACK) [ Time Frame: Baseline and 6 months ]

Central Contacts and Locations

Central contacts

Jessica A Wojtalik, PhD

216-368-1329reach-study@case.edu

Locations

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Jessica A Wojtalik, PhD

216-368-1329reach-study@case.edu

More Information

Sponsor

Case Western Reserve University

Last update posted

Aug 17, 2026

Last verified

Apr, 2026

Keywords

  • Clubhouse Model of Psychosocial Rehabilitation
  • Community mental health interventions
  • Cognition
  • Brain functioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-08-17.