Cognitive Rehabilitation for Victims of War and Related Traumas With Traumatic Brain Injury and Cognitive Impairment

Официальное название

Feasibility RCT of an Adapted Cognitive Rehabilitation Program for Victims of War and Related Traumas With TBI and Cognitive Impairment

Обзор

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.)

Подробное описание

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.

Вмешательства

• Поведенческое A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation Program
  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

Первичные конечные точки

• Acceptability of the intervention [Срок оценки: Through Intervention participation, an average of 8 weeks, and at the 12 weeks and 24 weeks follow-up questionnaires.]
• Acceptability of the intervention [Срок оценки: After the intervention at the 12 weeks and 24 weeks follow-up questionnaires.]
• Feasibility of the intervention [Срок оценки: Baseline, and through Intervention participation, an average of 8 weeks.]
• Feasibility of the intervention [Срок оценки: After the intervention at 12 weeks and 24 weeks follow-up questionnaires.]
• Satisfaction with the intervention [Срок оценки: After the intervention at the, 12 weeks and 24 weeks follow-up questionnaires.]

Вторичные конечные точки (5)

• Potential effectiveness on reducing cognitive impairment symptoms in objective measures [Срок оценки: Baseline, 12 weeks and 24 weeks follow-up questionnaires]
• Potential effectiveness on reducing cognitive impairment symptoms in objective measures [Срок оценки: Baseline, 12 weeks and 24 weeks follow-up questionnaires]
• Potential effectiveness on reducing cognitive impairment symptoms in subjective measures [Срок оценки: Baseline, 12 weeks and 24 weeks follow-up questionnaires]
• Potential effectiveness on reducing cognitive impairment symptoms in subjective measures [Срок оценки: Baseline, 12 weeks and 24 weeks follow-up questionnaires]
• Potential effectiveness on reducing post-concussive symptoms [Срок оценки: Baseline, 12 weeks and 24 weeks follow-up questionnaires]

Критерии участия

Критерии включения

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

Критерии исключения

• Participation in cognitive rehabilitation treatment current or in past 3 months
• Severe TBI or TBI only sustained under the age of 18
• Diagnosis of bipolar, psychosis, active substance use, self-reported current active suicidal ideation (Potential participants can be screened again after 30 days in the case of suicidal ideation)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Публикации

• 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. PMID 41937583
• 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. PMID 36251204
• 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. PMID 39874279
• 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. PMID 37019660
• 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. PMID 38928599
• 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. PMID 38831593

Идентификаторы

NCT: NCT06839079 · 2024P002728 · K23NS128164

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗