Recruiting

Cognitive Program

Sponsor:

Massachusetts General Hospital

Code:

NCT06839079

Conditions

TBI (Traumatic Brain Injury)

Cognitive Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation Program

Study Details

Brief summary:

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.)

Conditions

TBI (Traumatic Brain Injury)

Cognitive Symptoms

Study ID

NCT06839079

Start date

Oct 15, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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:

1. Participation in cognitive rehabilitation treatment current or in past 3 months
2. Severe TBI or TBI only sustained under the age of 18
3. 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)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Adapted cognitive rehabilitation program intervention

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.

no intervention: Waitlist Control

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)

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Altaf Saadi, MD

6177363016ASAADI@MGH.HARVARD.EDU

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Margarita G Velasco, MA

617-724-4957saadilab@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • Traumatic Brain Injury
  • Cognition
  • Refugees
  • Asylum Seekers
  • IPV
  • trauma-exposed populations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-09.