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NCT Number: NCT07625098

Feasibility of SUPPORT-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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location contact

Curtis Comer, Clinical Research Coordinator I

CONTACT

[email protected]

Jessica Kersey

PRINCIPAL_INVESTIGATOR

Jessica Kersey, PhD, OTR/L

CONTACT

[email protected]

3142737540

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SUPPORT-TBI

Behavioral

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.

Primary outcomes

  1. HEAL Treatment Expectancy Short Form

    Time frame: 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).

  2. Pittsburgh Rehabilitation Participation Scale

    Time frame: 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.

  3. Study-specific fidelity checklist

    Time frame: 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.

Secondary outcomes

  1. MOS Social Support Survey

    Time frame: Baseline, Post-intervention (12 weeks)

    19-item questionnaire examining perceived social support on a 5-point Likert scale with transformed scores (0-100).

  2. PROMIS Ability to Participate in Social Roles and Activities

    Time frame: Baseline, Post-intervention (12 weeks)

    Computer adaptive test examining social participation abilities; scores reported as T-scores.

  3. PROMIS-29

    Time frame: Baseline, Post-intervention (12 weeks)

    29-item measure of multiple health domains using a 5-point Likert scale and reported as T-scores.

Study contacts

Contact information is provided by the study sponsor or research team.

Curtis Comer, Clinical Research Coordinator I

CONTACT

[email protected]

3142733288

Jessica Kersey, PhD, OTR/L

CONTACT

[email protected]

3142737540

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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