Cognitive Rehabilitation for Refugees and Asylum Seekers with Traumatic Brain Injury and Cognitive Impairment

Not Applicable

Not yet recruiting

• Conditions: TBI (Traumatic Brain Injury); Cognitive Symptoms

• Registration Number: NCT06839079
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Study Start: 2025-09
• Primary Completion: 2027-03
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability of the intervention	After the intervention at the 1st and 3rd month follow-up questionnaires.	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.
Feasibility of the intervention	After the intervention at 1st and 3rd month follow-up questionnaires.	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.
Satisfaction with the intervention	After the intervention at the, 1st and 3rd Month follow-up questionnaires.	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.

Secondary Outcome Measures

Name	Time	Method
Potential effectiveness on reducing cognitive impairment symptoms in objective measures	Baseline, 1st and 3rd month follow-up questionnaires	Improvement in cognitive function will be assessed through changes on: Rowland Universal Dementia Assessment Scale (RUDAS) measure. The RUDAS maximum score is 30; a score of 23 and higher is considered normal and lower than this cut off will indicate possible cognitive impairment.
Potential effectiveness on reducing cognitive impairment symptoms in subjective measures	Baseline, 1st and 3rd month follow-up questionnaires	Improvement in cognitive function will be assessed through changes in the cognitive questions of Neurobehavioral Symptom Inventory (NSI). The NSI total score ranges from 0 to 88 and it can provide raw scores for four domains, one of them cognitive. A higher score indicates more severe post-concussive symptoms.
Potential effectiveness on reducing post-concussive symptoms	Baseline, 1st and 3rd month follow-up questionnaires	Improvement in post-concussive symptoms will be measured using the Neurobehavioral Symptom Inventory (NSI). The NSI total score ranges from 0 to 88. A higher score indicates more severe post-concussive symptoms.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States