PTSD Clinical Trial
Official title:
Comparing the Effectiveness of Telehealth to In-person Delivery of a Combined Metacognitive and Attention Training in Veterans With mTBI/PTSD
Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.
Status | Recruiting |
Enrollment | 63 |
Est. completion date | October 31, 2026 |
Est. primary completion date | October 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 55 Years |
Eligibility | Inclusion Criteria: - Veterans who have served in OIF-OEF-OND and have been diagnosed with both a mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) based on the joint criteria of the Veterans' Affairs and Department of Defense (VA & DoD). - Latest mTBI occurred at least 6 months prior to study enrollment. - Attention deficit of 1.5 SD below the mean of the RBANS attention index. - Family member or friend that is willing to complete a questionnaire. - Access to a home computer, or smartphone with internet access. Exclusion Criteria: - History of pre-morbid learning disability. - History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization. - Neurological disease unrelated to TBI (seizure disorder, stroke). - Score < 90 on National Adult Reading Test (NART). - Failure of validity testing on the Test of Memory Malingering (TOMM). - Reported alcohol or substance abuse within the past year. - Reported involvement in current litigation related to injury. - Recent change of medications for seizures, depression, or memory. - Currently enrolled in other cognitive therapy that cannot be discontinued. - Does not speak English fluently. - Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation). - Uncontrolled, acute medical or psychiatric condition as indicated by the participant or observed by the research team member that would make it unsafe to participate in the research activities, i.e. precautions for active homicidal/suicidal intent, active psychosis, or acute symptoms requiring immediate medical attention. |
Country | Name | City | State |
---|---|---|---|
United States | North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the Composite Executive score of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research | computerized performance measure that assess overall executive function. Composite Executive score, which is a single score that represent performance across the Dot Counting, N-back, Flanker, Continuous Performance Test, Fluency subscales, with a range of -3.0 to 3.0 with higher scores indicating better executive function. | pre-intervention, post, 6-month and 1-year follow-up | |
Secondary | Change in the Test of Grocery Shopping Skills | Functional task that measures efficiency of shopping for 10-items in an actual grocery store. Variables include Total Time and number of redundant Aisles, with less time and redundant Aisles indicating better performance. | week 1, week 11 | |
Secondary | Change in the attention index of the Repeatable Battery for the Assessment of Neuropsychological Status | performance measure of digit span and coding to measure attention. Range is 0-100 with higher scores indicating better attention. | week 1, week 11, week 35 and week 59 | |
Secondary | Change in Attention Network Task | Experimental computer administered flanker task to measure alerting, orienting and executive control components of attention. Range is -200 to 200 with higher scores indicating more impairment. | week 1, week 11, week 35 and week 59 | |
Secondary | Change in Traumatic Brain Injury-Quality of Life, Participation Ability and Satisfaction short-form | Self-report questionnaire to measure participation, range is 59-295 with higher scores indicating better participation | week 1, week 11, week 35 and week 59 | |
Secondary | Change in the Unstructured Task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research | Functional Task performed in the clinic that uses strategies in paper and pencil puzzles to gain the most points possible within 6 minutes. The Unstructured Task Variable has a range of 0-1,469 points with higher points indicating better performance. | week 1, week 11, week 35 and week 59 |
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