Virtual cognitive rehabilitation program for refugees with traumatic brain injury
Feasibility RCT of an Adapted Cognitive Rehabilitation Program for Refugees and Asylum Seekers With TBI and Cognitive Impairment
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06839079 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Identify as an asylum seeker, refugee or have been granted asylum or other form of humanitarian relief. 2. Mild or moderate TBI sustained after the age of 18 3. Age 18-65 4. Subjective cognitive impairment 5. English or Spanish language proficiency 6. Ability to provide verbal informed consent 7. 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 or plan (Potential participants can be screened again after 30 days in the case of suicidal ideation)
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Altaf Saadi, MD
- Email: ASAADI@MGH.HARVARD.EDU
- Phone: 6177363016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.