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Narrative Discourse Treatment Development

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Primary completion date changed from estimate of Sep 30, 2026 to Oct 10, 2025 · Eligibility criteria expanded, about 25 words · Publications: details revised at 1 of 1 entry Show 3 more changesShow less
    • Primary completion date changed from estimate of Sep 30, 2026 to Oct 10, 2025
    • Eligibility criteria expanded, about 25 words
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv12
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 40 to confirmed 34 · Site details revisedv11 Show 2 more changesShow less
    • Enrollment target: estimated 40 to confirmed 34
    • Site details revised
  4. Re-verified, no change to tracked fieldsv10
  5. Trial status: Not Yet Recruiting to Recruiting Site details revisedv9 Show 1 more changeShow less
    • Site details revised
Show 7 earlier versionsHide 7 earlier versions
  1. Start date: Nov 2, 2023 to Nov 27, 2023v8
  2. Start date: Oct 2, 2023 to Nov 2, 2023v7
  3. Start date: Jul 10, 2023 to Oct 2, 2023v6
  4. Start date: Apr 1, 2023 to Jul 10, 2023 Site details revisedv5 Show 1 more changeShow less
    • Site details revised
  5. Start date: Jan 1, 2023 to Apr 1, 2023 Eligibility criteria shortened, about 15 wordsv4 Show 1 more changeShow less
    • Eligibility criteria shortened, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv3
  7. Primary endpoints revised (3) Site contact updatedv2 Show 1 more changeShow less
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05008419
Lead Sponsor VA Office of Research and Development
Conditions Traumatic Brain Injury, Neurogenic Communication Disorders
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov