VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770, United States
NCT Number: NCT05008419
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
West Haven, Connecticut, 06516-2770, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
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")
VA Office of Research and Development
Fed
Remediating Narrative Discourse Impairments in Veterans With TBI: Initial Treatment Development
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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