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NCT Number: NCT06839079

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

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.)

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Key information

Conditions

TBI (Traumatic Brain Injury) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognitive Symptoms Craniocerebral Trauma Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Margarita G Velasco, MA

CONTACT

[email protected]

617-724-4957

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Acceptability of the intervention

    Time frame: Through Intervention participation, an average of 8 weeks, and at the 12 weeks and 24 weeks follow-up questionnaires.

    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.

  2. Acceptability of the intervention

    Time frame: After the intervention at the 12 weeks and 24 weeks follow-up questionnaires.

    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.

  3. Feasibility of the intervention

    Time frame: Baseline, and through Intervention participation, an average of 8 weeks.

    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).

  4. Feasibility of the intervention

    Time frame: After the intervention at 12 weeks and 24 weeks follow-up questionnaires.

    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.

  5. Satisfaction with the intervention

    Time frame: After the intervention at the, 12 weeks and 24 weeks follow-up questionnaires.

    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.

Secondary outcomes

  1. Potential effectiveness on reducing cognitive impairment symptoms in objective measures

    Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires

    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

  2. Potential effectiveness on reducing cognitive impairment symptoms in objective measures

    Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires

    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.

  3. Potential effectiveness on reducing cognitive impairment symptoms in subjective measures

    Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires

    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.

  4. Potential effectiveness on reducing cognitive impairment symptoms in subjective measures

    Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires

    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.

  5. Potential effectiveness on reducing post-concussive symptoms

    Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Altaf Saadi, MD

CONTACT

[email protected]

6177363016

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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