Researchers at Massachusetts General Hospital are looking to see if a program created to help improve thinking and memory can work for people affected by trauma, including asylum seekers and refugees, survivors of intimate partner violence (IPV) and others 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.)
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. TBI also impacts other populations impacted by trauma, irrespective of their immigration status. For example, this includes survivors of intimate partner violence. Due to their trauma exposure, they encounter overlapping issues as asylum-seekers and refugees, such as their TBI-related symptoms being overlooked due to their psychiatric history, IPV and TBI-related stigma, and under-detection and under-treatment of their TBI-related symptoms. Therefore, we look at trauma-exposed populations collectively as "victims of war and related traumas" or "trauma-exposed populations" to be succinct. 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 trauma-exposed populations 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
50
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGAcceptability 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: After the intervention at the, 12 weeks and 24 weeks follow-up questionnaires.
Potential effectiveness on reducing cognitive impairment symptoms in objective measures
Improvement in cognitive function will be assessed through changes on Montreal Cognitive Assessment (MoCA). The MoCA's highest possible score is 30; a score of 26 and higher is considered normal and lower than this cut off will indicate possible cognitive impairment
Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Potential effectiveness on reducing cognitive impairment symptoms in objective measures
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.
Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Potential effectiveness on reducing cognitive impairment symptoms in subjective measures
Improvement in cognitive function will be assessed through changes in: PROMIS (Patient Reported Outcome Measurement Information System) Short Form v2.0 - Cognitive Function 8a scale. The scale uses a T score metric where 50 is the mean (the average for the United States general population) and 10 is the standard deviation above or below the mean. A higher score indicates better cognitive performance.
Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Potential effectiveness on reducing cognitive impairment symptoms in subjective measures
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.
Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Potential effectiveness on reducing post-concussive symptoms
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.
Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.