An interventional study of Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness and Usual Community-Based Mental Health Care in Schizophrenia, Schizo Affective Disorder and Schizophreniform Disorders, sponsored by Case Western Reserve University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Treatment
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 30 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Case Western Reserve University is the lead sponsor of 160 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness
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.
Behavioral: Usual Community-Based Mental Health Care
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 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.
Change in overall cognitive performance as measured by MATRICS Consensus Cognitive Battery (MCCB)
The MATRICS Consensus Cognitive Battery (MCCB), which was developed by NIMH as a standardized assessment tool as an outcome measure of cognitive change in intervention trials. This performance-based battery contains 10 field standard, individually administered computer and paper-and-pencil tests of neurocognition (processing speed, attention, working memory, verbal learning, visual learning, and problem solving) and social cognition. The MCCB takes approximately 60-90 minutes to administer. The overall composite score (M = 50, SD = 10) with higher scores indicated better cognitive performance.
Time frame: Baseline and 6 months
Change in functional outcome as measured by Specific Levels of Functioning Scale (SLOF)
The SLOF is a 30-item self-and/or informant-report measure of interpersonal relationships, social acceptability, community activities, and living and work skills rated on a 5-point scale, with higher scores reflecting better functional outcome.
Time frame: Baseline and 6 months
Change in quality of life as measured by World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF)
The WHOQOL-BREF is a 26-item quality of life (QoL) measure developed by the World Health Organization of physical health, psychological, social relationships, and environment QoL. Items are rated on a 5-point scale, with higher scores reflecting better QoL.
Time frame: Baseline and 6 months
Change in disability as measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0
A brief (12-item), universal interviewer/self-report measure of functional disability that assesses 6 areas (mobility, life activities, cognition, participation, self-care, getting along with others) rated on level of difficulty in the past 30 days with higher scores indicating more disability.
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)
An NIMH validated fMRI task of goal maintenance (attention) in schizophrenia. This task implements the "A-then-X rule" where participants are instructed to make an index finger button press only when "A" precedes "X" (target trial, 72%) and a middle finger press for all other "non-target" trials (AY: 11%; BX: 11%; BY: 6%) for a total of 4 blocks of 36 trials (144 total). Trials are presented for 500ms followed by a cue (+) presentation for 1000ms (target or non-target response expected) with an interstimulus interval of 2000ms. Instructions and practice trials are embedded. The main contrast of interest for group-level analyses is the high vs. low cognitive load trials (cue A \> cue B), with greater fronto-limbic brain activation during high cognitive load indicating strong attention-related brain activation.
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)
A modified version of the standard working memory n-back task. This task includes 8 blocks (4 are 0-back and 4 are 2-back) of 12 trials. Each block starts with instructions indicating the condition (0-back or 2-back) presented for 3500ms, which is followed by the target stimulus (letters) flanked by emotional valence distractor conditions (happy, fearful, neutral, or no face) for 500ms, with an interstimulus interval jittered at an average of 3500ms. Blocks with emotional vs. no distractors are randomly interspersed throughout. The main contrasts of interest for group-level analyses are working memory load (2-back \> 0-back) and emotion distractor conditions (happy \> neutral; fearful \> neutral), with greater activation during the 2-back and emotional distractor conditions indicating better working memory and emotion regulation brain functioning.
Time frame: Baseline and 6 months
Change in social cognition (emotion recognition) as measured by Penn Emotion Recognition Task (ER-40)
Measures the ability to accurately identify different emotions (i.e., happy, sad, anger, and fear) in 40 colored images of human faces with a computer-administered, performance-based, and forced-choice format. Generates a total score of correctly identified emotions, with higher scores indicative of better emotional recognition ability.
Time frame: Baseline and 6 months
Change in social cognition (social inference) as measured by The Awareness of Social Inference Test, part III (TASIT)
The TASIT is a performance-based assessment that includes 16 short video vignettes (15 to 60 seconds) of social exchanges between actors. After watching a vignette, participants are asked four questions regarding their perceptions of lies or sarcasm in the social exchange. A total score is generated of correct responses, with higher scores indicative of better social inference ability.
Time frame: Baseline and 6 months
Change in social cognition (theory of mind) as measured by the Hinting Task
Requires theory of mind to infer the genuine intentions of a character's indirect speech to a second character across 10 short stories read by the test administrator. Created as a performance-based measure of theory of mind ability in people with schizophrenia. A total score of correct responses is yielded, with higher scores reflecting stronger ability to correctly perceive the hint of the character's true intention.
Time frame: Baseline and 6 months
Change in functional capacity as measured by he UCSD Performance-Based Skills Assessment, Brief version (UPSA-B)
The UCSD Performance-Based Skills Assessment is a brief performance-based measure of functional capacity of financial and communication skills. Scores range from 0 to 100, with higher scores indicating better functional capacity.
Time frame: Baseline and 6 months
Change in Self-Efficacy as measured by the New General Self-Efficacy Scale (NGSE)
The New General Self-Efficacy Scale (NGSE) is an 8-item self-report questionnaire designed to assess an individual's overall belief in their ability to perform well across a variety of situations. Respondents rate their agreement with each statement on a 5-point Likert scale, ranging from 0 (strongly disagree) to 4 (strongly agree). The total score range is from 0-32 with higher scores indicating greater self-efficacy.
Time frame: Baseline and 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jan 2028, 16 months after the start.
Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 16 months is below that.
Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: start Aug 2026 → Sep 2026 and completion Jan 2028 → Jan 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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