REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)

Официальное название

Pilot Study of the Cognitive and Neurobiological Effects of the Clubhouse Model of Psychosocial Rehabilitation for Schizophrenia and Related Conditions

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (5)

• Change in social cognition (emotion recognition) as measured by Penn Emotion Recognition Task (ER-40) [Срок оценки: Baseline and 6 months]
• Change in social cognition (social inference) as measured by The Awareness of Social Inference Test, part III (TASIT) [Срок оценки: Baseline and 6 months]
• Change in social cognition (theory of mind) as measured by the Hinting Task [Срок оценки: Baseline and 6 months]
• Change in functional capacity as measured by he UCSD Performance-Based Skills Assessment, Brief version (UPSA-B) [Срок оценки: Baseline and 6 months]
• Change in Self-Efficacy as measured by the New General Self-Efficacy Scale (NGSE) [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

• (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

Критерии исключения

• (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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Case Western Reserve University — Cleveland

Идентификаторы

NCT: NCT07006935 · STUDY20250623

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗