Clinical trial NCT05008419: Narrative Discourse Treatment Development
Official title: Remediating Narrative Discourse Impairments in Veterans With TBI: Initial Treatment Development
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Neurogenic Communication Disorders
Keywords: traumatic brain injury
neurogenic communication disorders
pragmatic communication disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 40 participants with TBI will be randomized to receive the discourse treatment with a telehealth component or Treatment as Usual (TAU).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Tolerability of treatment as measured by rates of attendance for all aspects of treatment
timeFrame: 2 months
measure: Feasibility of treatment as measured by dropout rate in the treatment condition
timeFrame: 2 months
measure: Acceptability of treatment as measured by a treatment satisfaction survey
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Karen Le, PhD
role: PRINCIPAL_INVESTIGATOR
References: