NCT06839079 · Massachusetts General Hospital
Cognitive Rehabilitation for Victims of War and Related Traumas With Traumatic Brain Injury and Cognitive Impairment
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 the topic, real-life examples and practice, and exercises to do outside of the sessions.
Primary outcome measures
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.
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.
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).
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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)
Where
- Boston, Massachusetts
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations