NCT06839079

Feasibility RCT of an Adapted Cognitive Rehabilitation Program for Refugees and Asylum Seekers With TBI and Cognitive Impairment

Recruiting now NA Last updated 8 March 2026

What this trial tests

NA trial testing A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation Program in TBI (Traumatic Brain Injury) in 50 participants. Currently enrolling.

Timeline

15 October 2025

Primary endpoint
1 March 2027

1 December 2027

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	50
Start date	15 October 2025
Primary completion	1 March 2027
Estimated completion	1 December 2027
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• TBI (Traumatic Brain Injury) — all drugs for TBI (Traumatic Brain Injury) →
• Cognitive Symptoms — all drugs for Cognitive Symptoms →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 65, any sex, with TBI (Traumatic Brain Injury) or Cognitive Symptoms. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

Researchers at Massachusetts General Hospital are looking to see if a program created to help improve thinking and memory can work for refugees 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.)

Publications & conference data

No peer-reviewed publications indexed yet for this trial.