Pilot Study of the Cognitive and Neurobiological Effects of the Clubhouse Model of Psychosocial Rehabilitation for Schizophrenia and Related Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in overall cognitive performance as measured by MATRICS Consensus Cognitive Battery (MCCB)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •(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
研究组 & 干预措施
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.
干预措施: Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness (Behavioral)
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.
干预措施: Usual Community-Based Mental Health Care (Behavioral)
结局指标
主要结局
Change in overall cognitive performance as measured by MATRICS Consensus Cognitive Battery (MCCB)
时间窗: Baseline and 6 months
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.
Change in quality of life as measured by World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF)
时间窗: Baseline and 6 months
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.
Change in disability as measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0
时间窗: Baseline and 6 months
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.
Change in task-based brain activation during functional MRI (fMRI) as measured by the AX-Continuous Performance Task (AX-CPT)
时间窗: Baseline and 6 months
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.
Change in task-based brain activation during functional MRI (fMRI) as measured by the Emotional Faces N-Based Task (EFNBACK)
时间窗: Baseline and 6 months
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.
Change in functional outcome as measured by Specific Levels of Functioning Scale (SLOF)
时间窗: Baseline and 6 months
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.
次要结局
- Change in social cognition (emotion recognition) as measured by Penn Emotion Recognition Task (ER-40)(Baseline and 6 months)
- Change in social cognition (social inference) as measured by The Awareness of Social Inference Test, part III (TASIT)(Baseline and 6 months)
- Change in social cognition (theory of mind) as measured by the Hinting Task(Baseline and 6 months)
- Change in functional capacity as measured by he UCSD Performance-Based Skills Assessment, Brief version (UPSA-B)(Baseline and 6 months)
- Change in social cognition (emotion recognition) as measured by Penn Emotion Recognition Task (ER-40)(Baseline and 6 months)
- Change in social cognition (social inference) as measured by The Awareness of Social Inference Test, part III (TASIT)(Baseline and 6 months)
- Change in social cognition (theory of mind) as measured by the Hinting Task(Baseline and 6 months)
- Change in functional capacity as measured by he UCSD Performance-Based Skills Assessment, Brief version (UPSA-B)(Baseline and 6 months)
- Change in Self-Efficacy as measured by the New General Self-Efficacy Scale (NGSE)(Baseline and 6 months)
研究者
Jessica Wojtalik
Assistant Professor
Case Western Reserve University