Virtual cognitive rehabilitation program for refugees with traumatic brain injury
Official title: Feasibility RCT of an Adapted Cognitive Rehabilitation Program for Victims of War and Related Traumas With TBI and Cognitive Impairment
Run by Massachusetts General Hospital · NCT06839079 · Data updated 2026-11-12
This trial will test whether a trauma-informed, paraprofessional-led virtual program can help English- and Spanish-speaking refugees and asylum seekers (ages 18–65) who have had mild-to-moderate TBI and are experiencing memory or thinking problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | March 2027 |
| Study ends | December 2027 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT06839079 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are refugees or asylum seekers aged 18–65 with mild-to-moderate TBI sustained after age 18, who report cognitive difficulties, speak English or Spanish, can give consent, and can participate in virtual sessions.
✕Probably not a fit
People with severe TBI, TBI only from childhood, active psychosis or bipolar disorder, current substance use problems, active suicidal ideation, or recent cognitive rehabilitation are unlikely to benefit or are excluded from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers at Massachusetts General Hospital have adapted an existing cognitive rehabilitation program to be delivered virtually by trained paraprofessionals and tailored for refugees and asylum seekers. In this pilot randomized trial, 50 participants (25 intervention, 25 wait-list control) will complete baseline, 12-week, and 24-week assessments. One group receives the program immediately and the other group receives it after a 12-week waiting period, allowing comparison of short-term changes and feasibility outcomes. The trial enrolls English- and Spanish-speaking adults with mild-to-moderate TBI and subjective cognitive complaints and focuses on practicality, acceptability, and preliminary changes in cognition and daily functioning.
Why it matters
Potential benefit: If successful, the program could improve thinking, memory, and everyday functioning for refugees with TBI while expanding access through a low-cost, virtual, paraprofessional delivery model.
How similar studies have gone: While cognitive rehabilitation has shown benefit for TBI in other populations, delivering a paraprofessional-led, trauma-informed virtual program specifically for refugees is largely novel and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Identify as asylum-seekers or refugees, survivors of intimate partner violence (IPV), OR report personal history of other trauma 3. Mild or moderate TBI sustained after the age of 18 4. Age 18-65 5. Subjective cognitive impairment 6. English or Spanish language proficiency 7. Ability to provide verbal informed consent 8. Ability and willingness to answer questionnaires and participation in the Intervention Exclusion Criteria: 1. Participation in cognitive rehabilitation treatment current or in past 3 months 2. Severe TBI or TBI only sustained under the age of 18 3. Diagnosis of bipolar, psychosis, active substance use, self-reported current active suicidal ideation (Potential participants can be screened again after 30 days in the case of suicidal ideation)
Where it's running
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Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Altaf Saadi, MD
- Email: ASAADI@MGH.HARVARD.EDU
- Phone: 6177363016
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.