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Feasibility of SUPPORT-TBI

2026년 8월 17일 업데이트: Jessica Kersey, Washington University School of Medicine

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

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.

연구 개요

상태

모병

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (추정된)

60

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Jessica Kersey, PhD, OTR/L
  • 전화번호: 3142737540
  • 이메일: jkersey@wustl.edu

연구 연락처 백업

  • 이름: Curtis Comer, Clinical Research Coordinator I
  • 전화번호: 3142733288
  • 이메일: curtisccomer@wustl.edu

연구 장소

    • Missouri
      • St Louis, Missouri, 미국, 63110
        • 모병
        • Washington University School of Medicine
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Jessica Kersey

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
HEAL Treatment Expectancy Short Form
기간: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
6-item measure of intervention satisfaction with a 5-point Likert scale (range 6-30).
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
Pittsburgh Rehabilitation Participation Scale
기간: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
Measure of engagement in intervention sessions (range 1-6); administered each session and combined into an intervention-wide engagement score.
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
Study-specific fidelity checklist
기간: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
Checklist measuring the percentage of adherence to the outlined intervention elements; administered each session and combined into an intervention-wide adherence rate.
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)

2차 결과 측정

결과 측정
측정값 설명
기간
MOS Social Support Survey
기간: Baseline, Post-intervention (12 weeks)
19-item questionnaire examining perceived social support on a 5-point Likert scale with transformed scores (0-100).
Baseline, Post-intervention (12 weeks)
PROMIS Ability to Participate in Social Roles and Activities
기간: Baseline, Post-intervention (12 weeks)
Computer adaptive test examining social participation abilities; scores reported as T-scores.
Baseline, Post-intervention (12 weeks)
PROMIS-29
기간: Baseline, Post-intervention (12 weeks)
29-item measure of multiple health domains using a 5-point Likert scale and reported as T-scores.
Baseline, Post-intervention (12 weeks)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Jessica Kersey, PhD, OTR/L, Washington University School of Medicine

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 17일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2028년 3월 31일

연구 등록 날짜

최초 제출

2026년 5월 22일

QC 기준을 충족하는 최초 제출

2026년 6월 1일

처음 게시됨 (실제)

2026년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 17일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 202512160
  • KL2TR002346 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

This study will produce feasibility data and clinical outcome data on 30 participants with brain injury and 30 support providers, comprising 30 total dyads who complete all research procedures together. Data collection will be performed at Washington University medical campus or community sites in and around St. Louis, MO. Session-level outcome data will include the patient-reported HEAL Treatment Expectancy short form, the HEAL Patient-Provider Connection short form, the Pittsburgh Rehabilitation Participation Scale, and our study-specific fidelity checklist. Intervention-level outcome data will include the Client Satisfaction Questionnaire-8, MOS Social Support Survey, PROMIS Ability to Participate in Social Roles and Activities, and PROMIS-29. Individual level processed data will be available for sharing.

IPD 공유 기간

Data will be made available within 6 months of the end of the grant period and will remain available for a minimum of 10 years.

IPD 공유 액세스 기준

There are no anticipated factors or limitations that will affect the access, distribution, or reuse of the de-identified scientific data generated by this proposal. Controlled access will not be used. The data that is shared will be shared by unrestricted download.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다