NCT06839079

Cognitive Rehabilitation for Refugees With Traumatic Brain Injury and Cognitive Impairment

Feasibility RCT of an Adapted Cognitive Rehabilitation Program for Refugees and Asylum Seekers With TBI and Cognitive Impairment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.)

Detailed description

There are many refugees and asylum seekers in the world ("refugees" from here on for simplicity). Many of them have suffered from traumatic brain injury (TBI) as a result of traumatic experiences like torture and interpersonal violence. Because of one or more TBI's, they can experience cognitive issues, or issues with learning, thinking, concentration and memory. Cognitive rehabilitation can be one effective way to reduce the burden of cognitive issues following TBI. Cognitive rehabilitation refers to a functionally oriented service of cognitive activities that can aim to lessen cognitive impairments or lessen the disabling impact of these impairments. Yet not all people access cognitive rehabilitation equally. We have tailored an existing cognitive rehabilitation program to be delivered virtually and through a paraprofessional for refugees with TBI and cognitive issues. A paraprofessional refers to a person from the community who does not have specialized medical training. This is a pilot feasibility randomized trial where English and Spanish-speaking participants will be randomized to either the adapted intervention (n = 25) or a wait-list control (n = 25) in the first stage. The participants in the adapted intervention will receive the intervention first while people in the wait-list control wait. People in the waitlist control will receive the intervention after approximately 12 weeks. All participants will have assessments at baseline, approximately 12 weeks, and 24 weeks after baseline. During the intervention, participants will complete a program that involves 8 sessions. The sessions will cover material relating to cognitive rehabilitation, such as exercises relating to external or internal memory strategies, aimed to improve cognitive challenges people with TBI experience. Participants assigned to the immediate intervention will receive the program and then answer the second questionnaire, approximately 12-weeks after their baseline. They will complete the third questionnaire approximately 24-weeks after their baseline Participants assigned to the waitlist control group will answer the baseline and second questionnaire 12 weeks after. They will then receive the intervention and complete the third questionnaire, approximately 24-weeks after their baseline.

Conditions

• TBI (Traumatic Brain Injury)
• Cognitive Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation Program	The intervention will involve 8 proposed individual sessions conducted virtually by a trained bilingual paraprofessional. The intervention will be provided in English or Spanish depending on the participant's preference. The sessions cover psychoeducation about TBI and related symptoms like depression and anxiety, and cognitive activities to address cognitive symptoms (e.g., relaxation strategies and exercises around improving attention, concentration, learning, and memory). Each session covers the topic, real-life examples and practice, and exercises to do outside of the sessions.

Timeline

• Start date: 2025-10-15
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2025-02-21
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States