RecruitingNot Applicable

Cognitive Rehabilitation for Refugees With Traumatic Brain Injury and Cognitive Impairment

United States50 participantsStarted 2025-10-15

Plain-language summary

Researchers at Massachusetts General Hospital are looking to see if a program created to help improve thinking and memory can work for refugees with traumatic brain injury (TBI). They're checking if this program is practical and if people find it helpful. The study will have two groups. Participants will complete a first questionnaire and then be assigned to a group by chance. One group will participate in the program immediately and then answer the second questionnaire (approximately 3 months after the first questionnaire they did). Then they will wait and then answer the third and final questionnaire approximately 6 months after the first one. The second group will wait and answer the second questionnaire approximately 3 months after the first one. Then they will receive the program and answer the third and final questionnaire (approximately 6 months after the first one they did.)

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Identify as an asylum seeker, refugee or have been granted asylum or other form of humanitarian relief.
. Mild or moderate TBI sustained after the age of 18
. Age 18-65
. Subjective cognitive impairment
. English or Spanish language proficiency
. Ability to provide verbal informed consent
. Ability and willingness to answer questionnaires and participation in the Intervention

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceptability of the intervention

Timeframe: Through Intervention participation, an average of 8 weeks, and at the 12 weeks and 24 weeks follow-up questionnaires.

Acceptability of the intervention

Timeframe: After the intervention at the 12 weeks and 24 weeks follow-up questionnaires.

Feasibility of the intervention

Timeframe: Baseline, and through Intervention participation, an average of 8 weeks.

Feasibility of the intervention

Timeframe: After the intervention at 12 weeks and 24 weeks follow-up questionnaires.

Satisfaction with the intervention

Timeframe: After the intervention at the, 12 weeks and 24 weeks follow-up questionnaires.

Trial details

NCT IDNCT06839079

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Altaf Saadi, MD

6177363016 ASAADI@MGH.HARVARD.EDU

View on ClinicalTrials.gov More TBI (Traumatic Brain Injury) trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Identify as an asylum seeker, refugee or have been granted asylum or other form of humanitarian relief.
. Mild or moderate TBI sustained after the age of 18
. Age 18-65
. Subjective cognitive impairment
. English or Spanish language proficiency
. Ability to provide verbal informed consent
. Ability and willingness to answer questionnaires and participation in the Intervention

Exclusion criteria

What they're measuring

Acceptability of the intervention

Timeframe: Through Intervention participation, an average of 8 weeks, and at the 12 weeks and 24 weeks follow-up questionnaires.

Acceptability of the intervention

Timeframe: After the intervention at the 12 weeks and 24 weeks follow-up questionnaires.

Feasibility of the intervention

Timeframe: Baseline, and through Intervention participation, an average of 8 weeks.

Feasibility of the intervention

Timeframe: After the intervention at 12 weeks and 24 weeks follow-up questionnaires.

Satisfaction with the intervention

Timeframe: After the intervention at the, 12 weeks and 24 weeks follow-up questionnaires.