Talking About Life Experiences: Protocol for Treatment Development and a Feasibility Trial of a Novel Narrative...

Cognitive-communication disorders are pervasive following traumatic brain injury (TBI), disrupting communication at the level of discourse and social interaction. Discourse impairments impact functioning across major life domains, such as work and social relationships, and overall quality of life. Problems with discourse affect all severity levels of TBI and persist over time. Veterans may experience even greater functional decline due to comorbid health conditions (eg, posttraumatic stress disorder, pain). The functional impact and chronicity of discourse impairments following TBI underscore the importance of treating these impairments.

This study aims to (1) develop, refine, and manualize a treatment protocol targeting narrative discourse-Talking About Life Experiences (TALE)-in people with TBI and (2) evaluate the feasibility of the TALE discourse treatment in a pilot randomized controlled trial (RCT).

This is a stage 1a (phase 1) and stage 1b (phase 2) treatment development study aligned with the Stage Model of Behavioral Therapies Research. All participants will be individuals with TBI and communication difficulties. In the treatment development phase (phase 1), 5-10 participants will be recruited to obtain key stakeholder feedback for treatment refinement. In the feasibility pilot phase (phase 2), 40 participants with TBI and communication difficulty will be randomized to receive the TALE intervention or treatment as usual. We will obtain information on the tolerability, acceptability, and feasibility of recruitment for the TALE intervention, as well as preliminary data on treatment delivery, assessment methods, and treatment effects. Assessments will be conducted at baseline, posttreatment, and at 1-month follow-up and will include measures of discourse ability, cognition, mental health, pain, functional communication, and daily functioning. Feedback regarding assessment and treatment will also be collected via surveys and exit interviews.

This study was funded in October 2021. Recruitment for phase 1 began on September 26, 2022. Seven participants were enrolled. Phase 1 concluded on November 17, 2023. Recruitment for phase 2 began on November 27, 2023. Thirty-four participants were enrolled. Data collection was completed on November 3, 2025. Data analysis has been conducted concurrently with data collection and is expected to continue until early-mid 2026. Results are expected to be published in peer-reviewed journals in late 2026 and early 2027.

Stakeholder feedback from the phase 1 treatment development trial will facilitate refinement of the TALE protocol in preparation for the phase 2 feasibility pilot RCT. Results from phase 2 will be used to determine the tolerability, acceptability, and feasibility of methods. Findings from this study will inform the development and implementation of a future fully powered RCT evaluating treatment efficacy.

ClinicalTrials.gov NCT05008419; https://clinicaltrials.gov/ct2/show/NCT05008419.

DERR1-10.2196/86329.