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Набор скоро начнётся NCT07625098

Feasibility of SUPPORT-TBI

Фаза I С лечением TBI Traumatic Brain Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SUPPORT-TBI.
Кому может быть актуально
Состояния в реестре: TBI Traumatic Brain Injury. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

From Isolation to Connection: A Dyadic Approach to Enhancing Health After TBI

Обзор

Many people who have had a traumatic brain injury (TBI) struggle to stay connected with others. They often lose friendships, become isolated, and have strained family relationships. This lack of social support is linked to worse physical and mental health, lower quality of life, and even a shorter lifespan. The investigators developed a program where a person with TBI and one close supporter work together with a therapist over 12 weekly sessions. They learn skills in communication, setting shared goals, supporting each other emotionally, and problem-solving, with occasional guidance from a peer mentor who has been through a similar experience. This study will determine whether the program is practical to deliver. We are conducting a pilot study with 30 pairs of participants to test whether sessions run smoothly, whether people show up and stay engaged, and whether participants find the program worthwhile. Based on what they learn, the investigators will refine this program before testing it on a larger scale. If successful, this could lead to a practical, low-risk intervention that improves the lives of people with TBI and the family members and friends who support them.

Подробное описание

People with traumatic brain injury (TBI) experience poor long-term health and daily life participation, yet current rehabilitation approaches fail to meaningfully improve these outcomes. Social support is closely associated with daily life participation and a range of physical and mental health outcomes. Further, it is an important protective factor against functional decline, chronic disease, mental illness, and early mortality. While social support is important for quality of life, few rehabilitation interventions leverage it as a mechanism for improving outcomes. People with TBI have particularly low social support. They experience shrinking social networks, loss of friendships, high rates of divorce, and reduced quality of family relationships. Yet, people with TBI value strong reciprocal relationships with one or two close family members as the key component of social support. This project will examine the feasibility of a novel dyadic intervention (SUPPORT-TBI) aimed at enhancing social support to promote greater participation and long-term health outcomes among people with TBI by improving the quality of a support relationship between the person with TBI and a close family member or friend. The goals of this intervention are to provide the dyad with strategies to sustain an effective support relationship. The investigators have designed SUPPORT-TBI to improve social support through five central intervention elements (1) communication strategies, (2) shared goals and activities, (3) psychosocial support, (4) peer mentorship, and (5) joint problem-solving. This intervention was developed based on a core elements review of existing social support intervention literature in other fields and populations and was guided by input from people with brain injury, their family members, brain injury rehabilitation providers, and brain injury intervention researchers. The investigators are currently refining it through a case series study. Though conceptually promising, evidence-based, and rooted in stakeholder priorities, our early pilot testing of this intervention has demonstrated that the proposed 12 weekly sessions is a burdensome time commitment and is difficult to schedule when involving the person with TBI, their support person, and peer mentors. These barriers, in addition to insurance barriers that limit coverage of outpatient and community-based rehabilitation services, suggest important implementation barriers that must be addressed as investigators refine this intervention protocol. To address this, investigators propose to optimize the intervention using the Multiphase Optimization Strategy (MOST). This framework will allow investigators to identify which intervention components, delivery structures, and dosages maximize efficiency without compromising intervention effects. In the proposed study, investigators will conduct the preparation phase of the MOST framework, which involves testing the feasibility of the proposed intervention elements to inform the design of a factorial, randomized optimization trial (MOST Phase 2). Investigators will conduct a feasibility study of the full protocol with 30 dyads, and examine participant satisfaction (HEAL Treatment Expectancy Short Form), engagement in intervention sessions(Pittsburgh Rehabilitation Participation Scale), and fidelity of delivery (study-specific fidelity checklist) of each intervention session. Then the investigators will select the combinations of conditions to be tested in the optimization phase by refining the delivery of each intervention element for feasibility and identifying the intervention elements, dosages, and delivery models likely to contribute to intervention effects while minimizing participant burden. This will enable the investigators to develop a thoughtful, comprehensive optimization study (MOST phase 2), and an eventual confirmation study to examine intervention effectiveness (MOST phase 3).

Вмешательства

  • Поведенческое SUPPORT-TBI
    This novel dyadic intervention incorporates essential elements of communication strategies, shared goals and activities, psychosocial support, peer mentorship, and problem-solving. The person with TBI and a close supporter complete intervention procedures together and work to develop sustainable strategies for an effective support relationship. The intervention is delivered in weekly 1-hour sessions for 12 consecutive weeks.

Первичные конечные точки

  • HEAL Treatment Expectancy Short Form [Срок оценки: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)]
  • Pittsburgh Rehabilitation Participation Scale [Срок оценки: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)]
  • Study-specific fidelity checklist [Срок оценки: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)]
Вторичные конечные точки (3)
  • MOS Social Support Survey [Срок оценки: Baseline, Post-intervention (12 weeks)]
  • PROMIS Ability to Participate in Social Roles and Activities [Срок оценки: Baseline, Post-intervention (12 weeks)]
  • PROMIS-29 [Срок оценки: Baseline, Post-intervention (12 weeks)]

Критерии участия

Критерии включения

  • Age 18 or older
  • Live in a community setting (not an institutional setting)
  • Sustained a traumatic brain injury more than 6 months prior to enrollment
  • Report mild-moderate TBI-related disability (score of 5 or greater) on the Glasgow Outcome Scale - Extended
  • Report low social support (score of less than 50 on the MOS Social Support Survey)

Критерии исключения

  • Insufficient English language fluency
  • Active substance use disorder (meets diagnostic criteria on the PRIME-MD MINI alcohol or non-alcoholic substances modules)
  • Active, untreated psychotic disorder (meets diagnostic criteria on the PRIME-MD MINI psychotic disorders module)
  • Severe memory impairment (score of less than 21 on the Montreal Cognitive Assessment)

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

Публикации

  • Kersey J, Schwartz J, Connor LT, Stark S. Delphi study for the development of a dyadic social support intervention for people with traumatic brain injury. Disabil Health J. 2026 Apr;19(2):101978. doi: 10.1016/j.dhjo.2025.101978. Epub 2025 Nov 6. PMID 41207858

Идентификаторы

NCT: NCT07625098 · 202512160 · KL2TR002346

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗