Skip to content

Feasibility of SUPPORT-TBI

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07625098
Enrollment
60
Registered
2026-06-04
Start date
2026-08-17
Completion date
2028-03-31
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TBI Traumatic Brain Injury

Brief summary

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.

Detailed description

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).

Interventions

BEHAVIORALSUPPORT-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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
HEAL Treatment Expectancy Short FormImmediately 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).
Pittsburgh Rehabilitation Participation ScaleImmediately 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.
Study-specific fidelity checklistImmediately 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

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

Countries

United States

Contacts

CONTACTJessica Kersey, PhD, OTR/L
jkersey@wustl.edu3142737540
CONTACTCurtis Comer, Clinical Research Coordinator I
curtisccomer@wustl.edu3142733288
PRINCIPAL_INVESTIGATORJessica Kersey, PhD, OTR/L

Washington University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026