Cognitive Rehabilitation for Refugees With Traumatic Brain Injury and Cognitive Impairment

NCT06839079 | Recruiting DMC

• 2 other identifiers: 2024P002728K23NS128164
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.)

Conditions

TBI (Traumatic Brain Injury); Cognitive Symptoms

Keywords

Traumatic Brain Injury; Cognition; Refugees; Asylum Seekers

Outcome Measures

Primary Outcomes (5)

• Acceptability of the intervention

  At least 70% of participants will complete 7 or more sessions. At least 70% of participants will complete their homework. At least 80% of participants will complete the study and 12 weeks assessment. At least 60% of participants will complete the 24 weeks assessment.

  Through Intervention participation, an average of 8 weeks, and at the 12 weeks and 24 weeks follow-up questionnaires.

• Acceptability of the intervention

  At least 70% of participants will score over the midpoint in the 4-item Acceptability of Intervention Measure. The AIM scale values range from 1 to 5 with a higher score of 20. Higher scores indicate greater acceptability.

  After the intervention at the 12 weeks and 24 weeks follow-up questionnaires.

• Feasibility of the intervention

  At least 80% of people approached will agree to participate (feasibility of recruitment). At least 70% of participants will have no measures fully missing (feasibility of assessments).

  Baseline, and through Intervention participation, an average of 8 weeks.

• Feasibility of the intervention

  At least 70% of participants will score over the midpoint in the 4-item Feasibility of Intervention Measure (FIM). The FIM is a scale whose values range from 1-5 and a higher score of 20. Higher scores indicate greater acceptability.

  After the intervention at 12 weeks and 24 weeks follow-up questionnaires.

• Satisfaction with the intervention

  At least 70% of participants will score over the midpoint in the Client Satisfaction Questionnaire (CSQ-8). Scores for the CSQ-8 range from 8 to 32 and higher scores indicate greater satisfaction.

  After the intervention at the, 12 weeks and 24 weeks follow-up questionnaires.

Secondary Outcomes (5)

• Potential effectiveness on reducing cognitive impairment symptoms in objective measures

  Baseline, 12 weeks and 24 weeks follow-up questionnaires

• Potential effectiveness on reducing cognitive impairment symptoms in objective measures

  Baseline, 12 weeks and 24 weeks follow-up questionnaires

• Potential effectiveness on reducing cognitive impairment symptoms in subjective measures

  Baseline, 12 weeks and 24 weeks follow-up questionnaires

• Potential effectiveness on reducing cognitive impairment symptoms in subjective measures

  Baseline, 12 weeks and 24 weeks follow-up questionnaires

• Potential effectiveness on reducing post-concussive symptoms

  Baseline, 12 weeks and 24 weeks follow-up questionnaires

Study Arms (2)

Adapted cognitive rehabilitation program intervention

EXPERIMENTAL

Those in the immediate intervention arm will receive the adapted cognitive rehabilitation therapy program which includes virtual sessions delivered by a paraprofessional focused on improving cognitive function. They will complete baseline assessments (target outcomes and demographic and general health information) and take part in the post-intervention assessments (target outcomes and feasibility, acceptability, and satisfaction measures) at approximately 12 weeks and 24 weeks after baseline.

Behavioral: A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation Program

Waitlist Control

NO INTERVENTION

Those in the waitlist control arm will complete baseline assessments (target outcomes and demographic and health information) and receive communications once a week mimicking the contact of the intervention. They will also participate in the post-assessment at approximately 12 weeks, after which they will receive the intervention. After that, they will complete the third assessment, at approximately 24 weeks (target outcomes and feasibility, acceptability, and satisfaction measures)

Interventions

A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation Program BEHAVIORAL

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.

Adapted cognitive rehabilitation program intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as an asylum seeker, refugee or have been granted asylum or other form of humanitarian relief.
• Mild or moderate TBI sustained after the age of 18
• Age 18-65
• Subjective cognitive impairment
• English or Spanish language proficiency
• Ability to provide verbal informed consent
• Ability and willingness to answer questionnaires and participation in the Intervention

You may not qualify if:

• Participation in cognitive rehabilitation treatment current or in past 3 months
• Severe TBI or TBI only sustained under the age of 18
• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 36251204 BACKGROUND

• Sherman Rosa S, Nadal R, Saadi A. Research Letter: Assessing Traumatic Brain Injury in Refugees: Feasibility, Usability, and Prevalence Insights From a US-Based Clinical Sample. J Head Trauma Rehabil. 2025 Jul-Aug 01;40(4):E334-E339. doi: 10.1097/HTR.0000000000001037. Epub 2025 Jul 1.

  PMID: 39874279 BACKGROUND

• 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.

  PMID: 37019660 BACKGROUND

• 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.

  PMID: 38928599 BACKGROUND

• 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.

  PMID: 38831593 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Neurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Altaf Saadi, MD

CONTACT

6177363016; ASAADI@MGH.HARVARD.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator will be blinded to participant's group assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Model Details: Participants will be randomly assigned to one of two groups: Group A will receive the intervention immediately. Group B will initially not receive the intervention (waitlist control). After approximately 12 weeks period, Group B will receive the intervention (delayed start). All participants will complete questionnaires at three time points: Baseline (after enrollment) Approximately 12 weeks after baseline. Approximately 24 weeks after baseline.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 21, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: All data will be made available immediately following first publication relating to clinical trial. No end date.
• Access Criteria: Anyone who wishes to access the data will be able to do so from Harvard Dataverse. Data will be stored in accessible formats, such as excel/csv format.

Locations

US (1)