Clinical trial NCT07006935: REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Official title: Pilot Study of the Cognitive and Neurobiological Effects of the Clubhouse Model of Psychosocial Rehabilitation for Schizophrenia and Related Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Schizophreniform Disorders
Keywords: Clubhouse Model of Psychosocial Rehabilitation
Community mental health interventions
Cognition
Brain functioning
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Magnolia Clubhouse
name: The Centers
First posted: 2025-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in overall cognitive performance as measured by MATRICS Consensus Cognitive Battery (MCCB)
timeFrame: Baseline and 6 months
measure: Change in functional outcome as measured by Specific Levels of Functioning Scale (SLOF)
timeFrame: Baseline and 6 months
measure: Change in quality of life as measured by World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF)
timeFrame: Baseline and 6 months
measure: Change in disability as measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0
timeFrame: Baseline and 6 months
measure: Change in task-based brain activation during functional MRI (fMRI) as measured by the AX-Continuous Performance Task (AX-CPT)
timeFrame: Baseline and 6 months
measure: Change in task-based brain activation during functional MRI (fMRI) as measured by the Emotional Faces N-Based Task (EFNBACK)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in social cognition (emotion recognition) as measured by Penn Emotion Recognition Task (ER-40)
timeFrame: Baseline and 6 months
measure: Change in social cognition (social inference) as measured by The Awareness of Social Inference Test, part III (TASIT)
timeFrame: Baseline and 6 months
measure: Change in social cognition (theory of mind) as measured by the Hinting Task
timeFrame: Baseline and 6 months
measure: Change in functional capacity as measured by he UCSD Performance-Based Skills Assessment, Brief version (UPSA-B)
timeFrame: Baseline and 6 months
measure: Change in Self-Efficacy as measured by the New General Self-Efficacy Scale (NGSE)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Jessica A Wojtalik, PhD
role: PRINCIPAL_INVESTIGATOR
References: