Cognitive Rehabilitation for Refugees With Traumatic Brain Injury and Cognitive Impairment
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Health Services Research
- Masking
- Double (Investigator, Outcomes Assessor)
- Masking Description
- The investigator and members of the study staff conducting assessments will be blinded to participant's group assignment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Adapted cognitive rehabilitation program intervention |
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. |
|
|
No Intervention Waitlist Control |
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) |
|
Recruiting Locations
Boston 4930956, Massachusetts 6254926 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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.