Narrative Discourse Treatment Development

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Traumatic Brain Injury Neurogenic Communication Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

40 participants with TBI will be randomized to receive the discourse treatment with a telehealth component or Treatment as Usual (TAU).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Discourse Treatment

Biweekly discourse treatment sessions.

Group Type EXPERIMENTAL

Narrative discourse treatment

Intervention Type BEHAVIORAL

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.

Treatment as Usual

No treatment. Participants will engage in their usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No