Narrative Discourse Treatment Development

Traumatic Brain Injury Clinical Trial

Official title:

Remediating Narrative Discourse Impairments in Veterans With TBI: Initial Treatment Development

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05008419
• Other study ID #: C3494-W
• Secondary ID: 1IK2RX003494-01A
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: Karen Le, PhD
• Phone: (203) 932-5711
• Email: Karen.Le2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Discourse impairments are breakdowns in meaningful communication beyond the level of single sentences and have a functional impact on the lives of Veterans with TBI, disrupting return to work, communication re integration, socialization, and quality of life. The few prior attempts to treat discourse impairments have been small case studies and resulted in no change or limited gains. The proposed study evaluates the feasibility of a novel narrative discourse treatment that builds upon these prior attempts by addressing breakdowns in both story content and story organization using a theoretically-driven approach. If feasible, as demonstrated by tolerability and acceptability to participants, and later shown to be effective, the proposed discourse treatment has the potential to improve daily communication, which provides a gateway for Veterans with TBI to increase meaningful participation and improve functioning in major life domains.

Description:

Discourse intervention in TBI is a nascent area of research, and, to date, there have been only a few studies that have attempted to improve discourse ability in TBI. These prior attempts have been small case studies, produced no change or limited gains, and did not include Veterans with TBI. The proposed project is an early stage discourse treatment development study that will evaluate the feasibility of a novel narrative discourse treatment protocol that builds upon these prior attempts with an all-Veteran participant sample. The first part of the study will consist of initial manual development for the discourse treatment protocol and refinement.

The second part will involve a treatment feasibility trial to obtain information regarding the tolerability, acceptability, and fidelity of the proposed discourse treatment and preliminary data on treatment delivery and assessment methods as well as preliminary information about treatment effects. Forty participants will be randomized to either the discourse treatment group or Treatment as Usual control. Assessments will be conducted at baseline, post-treatment, and at 1-month follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Communication Disorders
• Traumatic Brain Injury

Intervention

Behavioral:
• Narrative discourse treatment
The protocol will incorporate elements from prior treatment studies that showed some promise: 1) hierarchical training, 2) variety of discourse stimuli, 3) development of skills and strategies for discourse processing, 4) structured training prompts, 5) meta-cognitive and meta-linguistic strategies, and 6) integration of learning principles. Novel treatment elements will include: 1) targeting both story content and story organization, 2) use of a discourse model to guide treatment, and 3) functional communication training. Treatment will be delivered twice a week over 8 weeks. There will be four treatment phases: education, story organization, story content, and integration of story organization and content.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of treatment as measured by rates of attendance for all aspects of treatment	Rates of attendance for all aspects of treatment, calculated as the number of treatment sessions attended across all treatment phases divided by total number of treatment sessions.	2 months
Primary	Feasibility of treatment as measured by dropout rate in the treatment condition	Dropout rate in the treatment condition will be calculated as the number of participants who do not complete treatment over total number of participants	2 months
Primary	Acceptability of treatment as measured by a treatment satisfaction survey	Percentage of participants who rate satisfaction with the treatment based on Likert-type survey (e.g., endorse "satisfied" or "very satisfied")	2 months