Treatment for communication issues in Veterans with brain injuries
Remediating Narrative Discourse Impairments in Veterans With TBI: Initial Treatment Development
This study is testing a new communication treatment for Veterans with brain injuries to see if it helps them tell better stories compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (West Haven, Connecticut) |
| Trial ID | NCT05008419 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel narrative discourse treatment aimed at improving communication for Veterans with traumatic brain injury (TBI) who experience discourse impairments. The approach focuses on enhancing both story content and organization through a structured treatment protocol. The study will first develop the treatment manual and then conduct a feasibility trial with 40 participants, comparing the new treatment to standard care. Assessments will be made at baseline, post-treatment, and one month later to gauge tolerability, acceptability, and preliminary effectiveness.
Who should consider this trial
Good fit: Ideal candidates are Veterans diagnosed with mild to moderate TBI who experience communication difficulties affecting their daily activities.
Not a fit: Patients with penetrating head injuries or developmental disabilities may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance communication abilities and overall quality of life for Veterans with TBI.
How similar studies have performed: Previous studies on discourse interventions in TBI have shown limited success, making this approach novel and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veteran with diagnosis of TBI with mild to moderate functional cognitive impairments * Self-report of communication difficulty following TBI that interferes with activities * Can identify a significant other (e.g., spouse, family member, friend) who is able and willing to serve as an informant, who will verify discourse ability pre- and post-treatment * The informant must be an individual with whom the participant engages in weekly social communication * Adequate hearing and visual acuity to participate in study procedures * Those who are willing and able to participate in telehealth sessions must have appropriate equipment and access * e.g., smartphone, tablet, computer with camera, internet access * Stable housing * Participants must have a safe, private and quiet environment in their home to engage in telehealth sessions * English as a primary language Exclusion Criteria: * Penetrating head injury * History of or current developmental disability (e.g., dyslexia), psychotic disorder, neurological illness * e.g., stroke, dementia, Parkinson's disease), aphasia or auditory processing disorder (APD) * Current (past 30 days) diagnosis of alcohol or substance abuse * An exception will be made for marijuana as a number of Veterans use marijuana occasionally to manage ailments, such as pain and PTSD * Marijuana use must not occur regularly or interfere with daily functioning * Inclusion of Veterans using marijuana aligns with the VA's position that Veterans will not be denied VA benefits because of marijuana use
Where this trial is running
West Haven, Connecticut
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Karen Le, PhD — VA Connecticut Healthcare System West Haven Campus, West Haven, CT
- Study coordinator: Karen Le, PhD
- Email: Karen.Le2@va.gov
- Phone: (203) 932-5711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.