Research Letter: Assessing Traumatic Brain Injury in Refugees: Feasibility, Usability, and Prevalence Insights From a US-Based Clinical Sample.
Sofia Sherman Rosa, Rodrigo Nadal, Altaf Saadi
https://pubmed.ncbi.nlm.nih.gov/39874279/Actively Recruiting
Led by Massachusetts General Hospital · Updated on 2026-07-09
50
Participants Needed
1
Research Sites
39 weeks
Total Duration
Researchers at Massachusetts General Hospital are studying a program designed to improve thinking and memory for people affected by trauma, including asylum seekers, refugees, survivors of intimate partner violence, and others with traumatic brain injury TBI. The study assesses whether this virtual cognitive rehabilitation program, delivered by a trained paraprofessional, is practical and helpful for adults aged 18 to 65 who have experienced mild to moderate TBI and cognitive difficulties. Participants will be randomly assigned to one of two groups. One group will start the cognitive rehabilitation program immediately, consisting of eight virtual sessions covering topics like memory strategies and cognitive exercises. The other group will wait for about 12 weeks before receiving the same program. Assessments will be conducted at the start, around 12 weeks, and about 24 weeks after the baseline to measure outcomes. During the study, participants will complete questionnaires and cognitive assessments at these time points to evaluate acceptability, feasibility, and satisfaction with the program, along with potential improvements in cognitive symptoms and post-concussive effects. The program is delivered virtually in English or Spanish, with follow-ups extending up to 24 weeks from the start. The study aims to gather important information on how well this intervention works for trauma-exposed adults with cognitive challenges.
CONDITIONS
Cognitive Rehabilitation for Victims of War and Related Traumas With Traumatic Brain Injury and Cognitive Impairment
A
Altaf Saadi, MD
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Massachusetts General Hospital
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Virtual trauma‑informed cognitive rehabilitation | No intervention (waitlist control) | Usual cognitive rehabilitation |
|---|---|---|---|
| What it is | Virtual trauma‑informed cognitive rehabilitation delivered by bilingual paraprofessionals via eight individual sessions with psychoeducation and cognitive activities for attention, memory and concentration. | Participants assigned to wait for the intervention and receive no active cognitive rehabilitation during the wait period. | Standard cognitive rehabilitation approaches for TBI commonly include restorative and compensatory strategies such as internal and external memory supports, metacognitive strategy training, and psychoeducation. |
| Role in the trial | Active investigational intervention delivered immediately. | Delayed receipt of intervention; no treatment during initial waiting period. | Represents typical non‑trial rehabilitation practices outside the study. |
| Primary use | To assess feasibility, acceptability and satisfaction of a culturally adapted virtual cognitive rehab program. | Serves as control condition to compare outcomes when intervention is delayed. | Reflects real‑world cognitive rehabilitation methods used in current clinical care outside the trial. |
| How it is given or performed | Eight individual virtual sessions delivered by bilingual paraprofessionals in English or Spanish including psychoeducation and cognitive exercises plus practice. | No sessions are delivered during the initial study period; participants later receive intervention. | Typically involves therapist‑led sessions using memory strategy training and compensatory supports in person or via telehealth. |
| Evidence status | Feasibility and acceptability being evaluated; effectiveness data not yet established. | No active intervention; serves as control comparator. | Supported by established evidence-based guidelines recommending memory and metacognitive strategies for TBI. |
| Important risks | Not reported in trial registry. | No intervention during waitlist period; safety profile not applicable. | Guidelines do not report specific safety concerns for these non‑invasive methods. |
| Important limitations | Evidence limited to feasibility in specific trauma‑exposed refugee/IPV survivor adults; effectiveness not yet demonstrated. | No active treatment during study period; outcomes reflect delayed intervention rather than comparison to active usual care. | Recommendations based on broader TBI populations; not specifically validated in trauma‑exposed refugees/IPV survivors. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - 24 weeks
Participants are randomly assigned to start the cognitive rehabilitation program immediately or after about 12 weeks. The program includes eight virtual sessions led by a trained paraprofessional to improve cognitive function. Questionnaires are completed at baseline, 12 weeks, and 24 weeks.
Eight virtual sessions plus three questionnaire assessments
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/36251204/Massachusetts General Hospital
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor