The Presence and Profile of Neurological Conditions and Associated Psychiatric Comorbidities in U.S. Resettled Refugees: A Retrospective Single Center Study.
A Parvez, S Percac-Lima, A Saadi
https://pubmed.ncbi.nlm.nih.gov/36251204Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06839079
Feasibility Randomized Trial of an Adapted Virtual Cognitive Rehabilitation Program for Refugees and Asylum Seekers With Traumatic Brain Injury and Cognitive Impairment
Led by Massachusetts General Hospital · Updated on 2026-03-11
50
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a cognitive rehabilitation program designed to help refugees and asylum seekers who have experienced traumatic brain injury (TBI) and suffer from cognitive challenges like problems with thinking, learning, concentration, and memory. This study aims to test if the program is practical to use and if participants find it helpful. The trial involves English and Spanish speakers and is conducted by Massachusetts General Hospital using a randomized design. Participants are randomly assigned to one of two groups. One group receives the adapted cognitive rehabilitation program immediately, which includes eight virtual sessions led by a trained bilingual paraprofessional. These sessions teach strategies for managing cognitive symptoms, such as relaxation, attention, memory exercises, and education about TBI and related symptoms like depression and anxiety. The second group serves as a waitlist control, completing assessments before receiving the program approximately 12 weeks later. Both groups complete questionnaires at baseline, 12 weeks, and 24 weeks. During the study, participants complete assessments to measure how acceptable, feasible, and satisfying the program is, along with questionnaires assessing cognitive symptoms and post-concussion effects. The program lasts about eight weeks, and follow-up questionnaires occur at 12 and 24 weeks after starting. Researchers monitor adherence and participant feedback throughout. The trial is open to adults aged 18 to 65 who meet specific criteria and will continue until December 2027.
CONDITIONS
Brief Title
Cognitive Rehabilitation for Refugees With Traumatic Brain Injury and Cognitive Impairment
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Identify as an asylum seeker, refugee, or have been granted asylum or humanitarian relief
- Experienced mild or moderate traumatic brain injury after age 18
- Age between 18 and 65 years
- Have subjective cognitive impairment
- Proficient in English or Spanish
- Able to provide verbal informed consent
- Willing and able to participate in the intervention and answer questionnaires
You will not qualify if you...
- Currently receiving or received cognitive rehabilitation treatment in the past 3 months
- Severe traumatic brain injury or TBI sustained only before age 18
- Diagnosis of bipolar disorder, psychosis, active substance use, or current active suicidal thoughts or plans (may be re-screened after 30 days if applicable)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Baseline Assessment
Duration - 1 day
Participants complete baseline assessments including target outcomes, demographic and general health information.
1 visit (virtual)
Adapted Cognitive Rehabilitation Program
Duration - Approximately 8 weeks
Participants complete 8 individual virtual sessions with a trained bilingual paraprofessional focused on cognitive rehabilitation to address cognitive symptoms related to traumatic brain injury.
Weekly virtual sessions for 8 weeks
Follow-up Assessments
Duration - Up to 24 weeks after baseline
Participants complete follow-up questionnaires to assess acceptability, feasibility, satisfaction, and potential effectiveness of the intervention at 12 weeks and 24 weeks after baseline.
2 virtual assessments at approximately 12 weeks and 24 weeks after baseline
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
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Research Team
A
Altaf Saadi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Published Research Related To This Trial
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/39874279Head Trauma in Refugees and Asylum Seekers: A Systematic Review.
Altaf Saadi, Jasmin Williams, Ameerah Parvez...
https://pubmed.ncbi.nlm.nih.gov/37019660Head Injury and Associated Sequelae in Individuals Seeking Asylum in the United States: A Retrospective Mixed-Methods Review of Medico-Legal Affidavits.
Altaf Saadi, Julia Asfour, Maria Vassimon De Assis...
https://pubmed.ncbi.nlm.nih.gov/38928599Clinician perspectives on characteristics and care of traumatic brain injury among asylum seekers and refugees.
Nusrath Jahan, Margarita Velasco, Ana-Maria Vranceanu...
https://pubmed.ncbi.nlm.nih.gov/38831593