Traumatic Brain InjuryNCT05008419
Narrative Discourse Treatment Development
A study testing Narrative discourse treatment in people with Traumatic Brain Injury and Neurogenic Communication Disorders, run by VA Office of Research and Development at 1 site in United States.
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 traumatic brain injury (TBI), disrupting return to work, communication re integration, socialization, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Neurogenic Communication Disorders
- What is being tested?
- Narrative discourse treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran with diagnosis of traumatic brain injury (TBI) with mild to moderate functional cognitive impairments
- Self-report of communication difficulty following traumatic brain injury 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
Show all 10Show fewer
- 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
Who cannot join
- 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 post-traumatic stress disorder (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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
About this study
Official title: Remediating Narrative Discourse Impairments in Veterans With TBI: Initial Treatment Development
Discourse impairments are breakdowns in meaningful communication beyond the level of single sentences and have a functional impact on the lives of Veterans with traumatic brain injury (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.
Read the 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.
- Being tested
- Narrative discourse treatment
- Keywords
- traumatic brain injury, neurogenic communication disorders, pragmatic communication disorders
- Medical subject headings
- Brain Injuries, Traumatic, Communication Disorders, Social Communication Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative discourse treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Discourse Treatment | Experimental | Biweekly discourse treatment sessions. Receives: Behavioral: Narrative discourse treatment |
| Treatment as Usual | No intervention | No treatment. Participants will engage in their usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
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
Measured: 2 months
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")
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start27 Nov 2023
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 40 participants with TBI will be randomized to receive the discourse treatment with a telehealth component or Treatment as Usual (TAU).
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Karen Le, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008419
- Sponsor's protocol ID
- C3494-W
- Other IDs
- 5IK2RX003494-03, 1IK2RX003494-01A2
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final data sets underlying all publications resulting from the research may be shared as per access criteria delineated below.
Publications
Le K, Coelho C, Feinn R, Fiszdon JM. Talking About Life Experiences: Protocol for Treatment Development and a Feasibility Trial of a Novel Narrative Discourse Intervention for Individuals With Traumatic Brain Injury. JMIR Res Protoc. 2026 Apr 24;15:e86329. doi: 10.2196/86329.
PubMed 42061839
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remediating Narrative Discourse Impairments in Veterans With TBI: Initial Treatment Development
- ClinicalTrials.gov ID
- NCT05008419
- Acronym / sponsor ID
- C3494-W
- Keywords
- traumatic brain injury, neurogenic communication disorders, pragmatic communication disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Discourse impairments are breakdowns in meaningful communication beyond the level of single sentences and have a functional impact on the lives of Veterans with traumatic brain injury (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 40 participants with TBI will be randomized to receive the discourse treatment with a telehealth component or Treatment as Usual (TAU).
| Arm | Type | Receives |
|---|---|---|
| Discourse Treatment | Experimental | Behavioral: Narrative discourse treatmentBiweekly discourse treatment sessions. |
| Treatment as Usual | No intervention | –No treatment. Participants will engage in their usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Veteran with diagnosis of traumatic brain injury (TBI) with mild to moderate functional cognitive impairments
- Self-report of communication difficulty following traumatic brain injury 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
- 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
Key exclusion criteria (7 listed)
- Penetrating head injury
- History of or current developmental disability (e.g., dyslexia), psychotic disorder, neurological illness
- Current (past 30 days) diagnosis of alcohol or substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative discourse treatmentThe 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. | Behavioural | Discourse Treatment |
Primary outcome
Tolerability of treatment as measured by rates of attendance for all aspects of treatment
Time frame: 2 months
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.
Feasibility of treatment as measured by dropout rate in the treatment condition
Time frame: 2 months
Dropout rate in the treatment condition will be calculated as the number of participants who do not complete treatment over total number of participants
Acceptability of treatment as measured by a treatment satisfaction survey
Time frame: 2 months
Percentage of participants who rate satisfaction with the treatment based on Likert-type survey (e.g., endorse "satisfied" or "very satisfied")
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 42061839Le K, Coelho C, Feinn R, Fiszdon JM. Talking About Life Experiences: Protocol for Treatment Development and a Feasibility Trial of a Novel Narrative Discourse Intervention for Individuals With Traumatic Brain Injury. JMIR Res Protoc. 2026 Apr 24;15:e86329. doi: 10.2196/86329.
- Individual participant dataSharing planned: Yes. Final data sets underlying all publications resulting from the research may be shared as per access criteria delineated below.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Le, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative discourse treatment in people with Traumatic Brain Injury and Neurogenic Communication Disorders, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of treatment as measured by rates of attendance for all aspects of treatment (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05008419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.