ENGAGE-TBI Feasibility Study

Обзор

This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.

Подробное описание

Social isolation is a prevalent and highly prioritized concern among people with traumatic brain injury (TBI), contributing to poor physical and mental health outcomes. Existing rehabilitation interventions have focused primarily on remediating underlying impairments, with limited success in improving social participation. A patient-directed, self-management approach may offer a promising alternative. This study aims to evaluate the feasibility of ENGAGE-TBI, a novel, theory-driven occupational therapy intervention designed to reduce social isolation by increasing social participation among community-dwelling adults with TBI. Using a single-group pre-post design, this study will enroll 30 adults with TBI recruited through the Brain Injury Association of Missouri. ENGAGE-TBI is a 12-session group intervention co-facilitated by an occupational therapist and a peer mentor with TBI. The intervention integrates three core elements - social learning, guided problem-solving, and skilled community practice - delivered across six weeks. Feasibility outcomes include fidelity, participant engagement, satisfaction, attendance, and retention. The primary clinical outcome is social participation, measured using the PROMIS Ability to Participate in Social Roles and Activities. Feasibility outcomes will be examined descriptively against pre-specified benchmarks. Within-group Cohen's d effect sizes with 95% confidence intervals will be calculated to estimate intervention effects and variability, informing the design of a future randomized controlled trial. Findings will support the development of a fully-powered effectiveness trial. This study addresses a critical gap in TBI rehabilitation by testing a stakeholder-informed, community-based intervention that treats TBI as a chronic condition and prioritizes patient-directed goal achievement over impairment remediation.

Вмешательства

• Поведенческое Social intervention study for TBI survivors
  ENGAGE-TBI is a community-based group intervention that is co-facilitated by an occupational therapist and a person with a brain injury. ENGAGE-TBI incorporates social learning, guided problem-solving, and skilled practice of strategies to achieve social participation goals. It is delivered in 12 90-minute group sessions that are held twice per week for 6 weeks. Aside from community outings, sessions will take place at the Brain Injury Association of Missouri on a separate day and time from educ

Первичные конечные точки

• Client Satisfaction Questionnaire-8 [Срок оценки: Post-Treatment (6-weeks)]
• Pittsburgh Rehabilitation Participation Scale [Срок оценки: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)]
• PROMIS (Patient-Reported Outcome Measures Information System) Ability to Participate in Social Roles and Activities [Срок оценки: Baseline, Post-Treatment (6-weeks)]

Вторичные конечные точки (2)

• PROMIS (Patient-Reported Outcome Measures Information System) Social Isolation [Срок оценки: Baseline, Post-Treatment (6-weeks)]
• PROMIS-29 (Patient-Reported Outcome Measures Information System) [Срок оценки: Baseline, Post-Treatment (6-weeks)]

Критерии участия

Критерии включения

• at least 18 years old
• experienced a TBI > 6 months prior to enrollment, confirmed by a physician as documented in their medical record
• live in the St. Louis area
• report problems with social participation (retention of < 80% of pre-TBI social activities as measured by Activity Card Sort)

Критерии исключения

• insufficient English language fluency to participate in the group intervention
• have active substance use disorder (PRIME-MD MINI)
• have an untreated psychotic disorder (PRIME-MD MINI)
• have severe memory impairment that would limit their ability to recall strategies with support (Montreal Cognitive Assessment, < 21)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT07549997 · 202503070

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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