Back to resultsNarrative Discourse Treatment Development
Primary Purpose
Traumatic Brain Injury, Neurogenic Communication Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrative discourse treatment
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, neurogenic communication disorders, pragmatic communication disorders
Eligibility Criteria
Inclusion Criteria:
- Veteran with diagnosis of TBI with mild to moderate functional cognitive impairments
- Self-report of communication difficulty following TBI 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
- 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
Exclusion Criteria:
- 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 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
Sites / Locations
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Discourse Treatment
Treatment as Usual
Arm Description
Biweekly discourse treatment sessions.
No treatment. Participants will engage in their usual care.
Outcomes
Primary Outcome Measures
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.
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
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")
Secondary Outcome Measures
Full Information
NCT ID
NCT05008419
First Posted
August 9, 2021
Last Updated
October 19, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05008419
Brief Title
Narrative Discourse Treatment Development
Official Title
Remediating Narrative Discourse Impairments in Veterans With TBI: Initial Treatment Development
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2, 2023 (Anticipated)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Neurogenic Communication Disorders
Keywords
traumatic brain injury, neurogenic communication disorders, pragmatic communication disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
40 participants with TBI will be randomized to receive the discourse treatment with a telehealth component or Treatment as Usual (TAU).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Discourse Treatment
Arm Type
Experimental
Arm Description
Biweekly discourse treatment sessions.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
No treatment. Participants will engage in their usual care.
Intervention Type
Behavioral
Intervention Name(s)
Narrative discourse treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tolerability of treatment as measured by rates of attendance for all aspects of treatment
Description
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
Title
Feasibility of treatment as measured by dropout rate in the treatment condition
Description
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
Title
Acceptability of treatment as measured by a treatment satisfaction survey
Description
Percentage of participants who rate satisfaction with the treatment based on Likert-type survey (e.g., endorse "satisfied" or "very satisfied")
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Veteran with diagnosis of TBI with mild to moderate functional cognitive impairments
Self-report of communication difficulty following TBI 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
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
Exclusion Criteria:
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Le, PhD
Phone
(203) 932-5711
Email
Karen.Le2@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Le, PhD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516-2770
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Le, PhD
Phone
203-932-5711
Email
Karen.Le2@va.gov
First Name & Middle Initial & Last Name & Degree
Karen Le, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Final data sets underlying all publications resulting from the research may be shared as per access criteria delineated below.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
De-identified data sets may be shared with other investigators, upon written request, under a data use agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The data sharing agreement will also restrict redistribution to third parties and proper acknowledgment of the data source. These data sets will be shared per guidelines provided by the VA Connecticut Healthcare System (VACHS) Information Security Officer.
Learn more about this trial
Narrative Discourse Treatment Development
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