Clinical trial NCT06839079: Cognitive Rehabilitation for Refugees and Asylum Seekers with Traumatic Brain Injury and Cognitive Impairment
Official title: Feasibility RCT of an Adapted Cognitive Rehabilitation Program for Refugees and Asylum Seekers with TBI and Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Cognitive Symptoms
Keywords: Traumatic Brain Injury
Cognition
Refugees
Asylum Seekers
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2025-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of two groups: 1) to receive the intervention after enrollment or 2) not to receive the intervention at enrollment. The second group not receiving the intervention ("waitlist control") will have the option of receiving the intervention at the end of their participation in the study. Both groups will answer questionnaires at enrollment and at the first and third months of participating in the study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Researchers at Massachusetts General Hospital are looking to see if a program created to help improve thinking and memory can work for refugees and asylum seekers 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, and people will be assigned to a group by chance. One group will participate in the program and answer questionnaires before starting the program and then one month and three months after the end of the program. The other group will answer a questionnaire after they enroll, then one month and three months after enrollment. People in this second group will have the option to participate in the program after three months.

Detailed description: There are many refugees and asylum seekers in the world. 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 lay people from the community for refugees and asylum seekers with TBI and cognitive issues.

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 intervention group, 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 will have assessments at baseline, 1- (upon competition of the program), and 3- month follow-up (3 months post baseline). Participants assigned to the waitlist control group will be seen for completion of measures after enrollment and at one and three moths after. After their final assessment, they will be offered the intervention.

Eligibility 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

Primary outcomes:
measure: Acceptability of the intervention
timeFrame: Through Intervention participation, an average of 8 weeks, and at the 1st and 3rd month follow-up questionnaires.
measure: Acceptability of the intervention
timeFrame: After the intervention at the 1st and 3rd month follow-up questionnaires.
measure: Feasibility of the intervention
timeFrame: Baseline, and through Intervention participation, an average of 8 weeks.
measure: Feasibility of the intervention
timeFrame: After the intervention at 1st and 3rd month follow-up questionnaires.
measure: Satisfaction with the intervention
timeFrame: After the intervention at the, 1st and 3rd Month follow-up questionnaires.
Secondary outcomes:
measure: Potential effectiveness on reducing cognitive impairment symptoms in objective measures
timeFrame: Baseline, 1st and 3rd month follow-up questionnaires
measure: Potential effectiveness on reducing cognitive impairment symptoms in objective measures
timeFrame: Baseline, 1st and 3rd month follow-up questionnaires
measure: Potential effectiveness on reducing cognitive impairment symptoms in subjective measures
timeFrame: Baseline, 1st and 3rd month follow-up questionnaires
measure: Potential effectiveness on reducing cognitive impairment symptoms in subjective measures
timeFrame: Baseline, 1st and 3rd month follow-up questionnaires
measure: Potential effectiveness on reducing post-concussive symptoms
timeFrame: Baseline, 1st and 3rd month follow-up questionnaires
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Parvez A, Percac-Lima S, Saadi A. The Presence and Profile of Neurological Conditions and Associated Psychiatric Comorbidities in U.S. Resettled Refugees: A Retrospective Single Center Study. J Immigr Minor Health. 2023 Apr;25(2):365-373. doi: 10.1007/s10903-022-01409-6. Epub 2022 Oct 17.
citation: Sherman Rosa S, Nadal R, Saadi A. Assessing Traumatic Brain Injury in Refugees: Feasibility, Usability, and Prevalence Insights From a US-Based Clinical Sample. J Head Trauma Rehabil. 2025 Jan 27. doi: 10.1097/HTR.0000000000001037. Online ahead of print.
citation: Saadi A, Williams J, Parvez A, Alegria M, Vranceanu AM. Head Trauma in Refugees and Asylum Seekers: A Systematic Review. Neurology. 2023 May 23;100(21):e2155-e2169. doi: 10.1212/WNL.0000000000207261. Epub 2023 Apr 5.
citation: Saadi A, Asfour J, Vassimon De Assis M, Wilson T, Haar RJ, Heisler M. Head Injury and Associated Sequelae in Individuals Seeking Asylum in the United States: A Retrospective Mixed-Methods Review of Medico-Legal Affidavits. Brain Sci. 2024 Jun 14;14(6):599. doi: 10.3390/brainsci14060599.
citation: Jahan N, Velasco M, Vranceanu AM, Alegria M, Saadi A. Clinician perspectives on characteristics and care of traumatic brain injury among asylum seekers and refugees. Disabil Rehabil. 2025 Feb;47(3):666-675. doi: 10.1080/09638288.2024.2356014. Epub 2024 Jun 3.