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| ID | Type | Description | Link |
|---|---|---|---|
| K23NS128164 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 12 weeks and 24 weeks follow-up questionnaires |
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Inclusion Criteria:
1. Identify as asylum-seekers or refugees, survivors of intimate partner violence (IPV), OR report personal history of other trauma 3. Mild or moderate TBI sustained after the age of 18 4. Age 18-65 5. Subjective cognitive impairment 6. English or Spanish language proficiency 7. Ability to provide verbal informed consent 8. Ability and willingness to answer questionnaires and participation in the Intervention
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Altaf Saadi, MD | Contact | 6177363016 | ASAADI@MGH.HARVARD.EDU |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41937583 | Background | Fauza S, Velasco M, Valera E, Saadi A. Traumatic brain injury-related stigma among intimate partner violence survivors. Brain Inj. 2026 Jun;40(8):674-683. doi: 10.1080/02699052.2026.2649542. Epub 2026 Apr 6. | |
| 36251204 | Background | 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. |
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All of individual participant data collected during the trial, after deidentification
All data will be made available immediately following first publication relating to clinical trial. No end date.
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.
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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.
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The investigator will be blinded to participant's group assignment.
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| 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. | 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. | 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. | 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. | Baseline, 12 weeks and 24 weeks follow-up questionnaires |
| 39874279 | 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. |
| 37019660 | 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. |
| 38928599 | 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. |
| 38831593 | 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. |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D019954 | Neurobehavioral Manifestations |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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