TBI Traumatic Brain InjuryPhase 1NCT07625098
Feasibility of SUPPORT-TBI
A Phase 1 study testing SUPPORT-TBI in people with TBI Traumatic Brain Injury, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI Traumatic Brain Injury
- What is being tested?
- SUPPORT-TBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to 31 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Jessica Kersey, PhD, OTR/L, 3142737540, jkersey@wustl.edu
Curtis Comer, Clinical Research Coordinator I, jkersey@wustl.edu
About this study
Official title: 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.
Read the 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).
- Conditions
- TBI Traumatic Brain Injury
- Being tested
- SUPPORT-TBI
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUPPORT-TBIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SUPPORT-TBI | Experimental | 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. Receives: Behavioral: SUPPORT-TBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
HEAL Treatment Expectancy Short Form
6-item measure of intervention satisfaction with a 5-point Likert scale (range 6-30).
Measured: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
Pittsburgh Rehabilitation Participation Scale
Measure of engagement in intervention sessions (range 1-6); administered each session and combined into an intervention-wide engagement score.
Measured: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
Study-specific fidelity checklist
Checklist measuring the percentage of adherence to the outlined intervention elements; administered each session and combined into an intervention-wide adherence rate.
Measured: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
Secondary outcomes (3)
MOS Social Support Survey
19-item questionnaire examining perceived social support on a 5-point Likert scale with transformed scores (0-100).
Measured: Baseline, Post-intervention (12 weeks)
PROMIS Ability to Participate in Social Roles and Activities
Computer adaptive test examining social participation abilities; scores reported as T-scores.
Measured: Baseline, Post-intervention (12 weeks)
PROMIS-29
29-item measure of multiple health domains using a 5-point Likert scale and reported as T-scores.
Measured: Baseline, Post-intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start17 Aug 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TBI Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Jessica Kersey, Washington University School of Medicine
- Investigators
- Jessica Kersey, PhD, OTR/L, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625098
- Sponsor's protocol ID
- 202512160
- Other IDs
- KL2TR002346
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41207858
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Isolation to Connection: A Dyadic Approach to Enhancing Health After TBI
- ClinicalTrials.gov ID
- NCT07625098
- Acronym / sponsor ID
- 202512160
- Conditions
- TBI Traumatic Brain Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUPPORT-TBI | Experimental | Behavioral: SUPPORT-TBIThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUPPORT-TBIThis 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. | Behavioural | SUPPORT-TBI |
Primary outcome
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).
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.
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.
3 secondary outcomes
MOS Social Support Survey
Time frame: Baseline, Post-intervention (12 weeks)
PROMIS Ability to Participate in Social Roles and Activities
Time frame: Baseline, Post-intervention (12 weeks)
PROMIS-29
Time frame: Baseline, Post-intervention (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 41207858Kersey 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Kersey, PhD, OTR/L principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SUPPORT-TBI in people with TBI Traumatic Brain Injury, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Kersey, PhD, OTR/L (3142737540, jkersey@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HEAL Treatment Expectancy Short Form (time frame: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07625098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.