Cognitive Rehabilitation for Refugees With Traumatic Brain Injury and Cognitive Impairment

Mass General Brigham

Status: Enrolling

Conditions: Cognitive Symptoms; TBI (Traumatic Brain Injury)

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06839079

2024P002728

K23NS128164 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.)

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Adapted cognitive rehabilitation program intervention

Experimental group

Description:

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.

Treatment:

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

Waitlist Control

No Intervention group

Description:

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)