REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorCase Western Reserve University
About this trial
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
This trial does not accept healthy volunteersQualifiers
(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
Disqualifiers
(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)
Trial design
Design model
Parallel
Treatments tested in this trial
Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness
BehavioralThe 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
BehavioralUsual 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Clubhouse Model of Psychosocial Rehabilitation for Serious Mental IllnessExperimental treatment 1 intervention
Group B: Usual Community-Based Mental Health CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 months4
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov