Narrative Discourse Treatment Development

Status Recruiting

Clinical 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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05008419
Study type	Interventional
Source	VA Office of Research and Development
Contact	Karen Le, PhD
Phone	(203) 932-5711
Email	Karen.Le2@va.gov
Status	Recruiting
Phase	N/A
Start date	November 27, 2023
Completion date	September 30, 2026

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03052712` - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies	N/A
Recruiting	`NCT05503316` - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System	N/A
Completed	`NCT04356963` - Adjunct VR Pain Management in Acute Brain Injury	N/A
Completed	`NCT03418129` - Neuromodulatory Treatments for Pain Management in TBI	N/A
Terminated	`NCT03698747` - Myelin Imaging in Concussed High School Football Players
Recruiting	`NCT05130658` - Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training	N/A
Recruiting	`NCT04560946` - Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI	N/A
Completed	`NCT05160194` - Gaining Real-Life Skills Over the Web	N/A
Recruiting	`NCT02059941` - Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines	N/A
Recruiting	`NCT03940443` - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting	`NCT03937947` - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Completed	`NCT04465019` - Exoskeleton Rehabilitation on TBI
Recruiting	`NCT04530955` - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)	N/A
Recruiting	`NCT03899532` - Remote Ischemic Conditioning in Traumatic Brain Injury	N/A
Suspended	`NCT04244058` - Changes in Glutamatergic Neurotransmission of Severe TBI Patients	Early Phase 1
Completed	`NCT03307070` - Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury	N/A
Recruiting	`NCT04274777` - The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
Withdrawn	`NCT05062148` - Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery	N/A
Withdrawn	`NCT04199130` - Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI	N/A
Withdrawn	`NCT03626727` - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.