RECRUITING

Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comparing the Effectiveness of Telehealth to In-person Delivery of a Combined Metacognitive and Attention Training in Veterans With mTBI/PTSD

Quick Facts

Study Start:2022-11-01
Study Completion:2026-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05380050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * Latest mTBI occurred at least 6 months prior to study enrollment.
  3. * Attention deficit of 1.5 SD below the mean of the RBANS attention index.
  4. * Family member or friend that is willing to complete a questionnaire.
  5. * Access to a home computer, or smartphone with internet access.
  1. * History of pre-morbid learning disability.
  2. * History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
  3. * Neurological disease unrelated to TBI (seizure disorder, stroke).
  4. * Score \< 90 on National Adult Reading Test (NART).
  5. * Failure of validity testing on the Test of Memory Malingering (TOMM).
  6. * Reported alcohol or substance abuse within the past year.
  7. * Reported involvement in current litigation related to injury.
  8. * Recent change of medications for seizures, depression, or memory.
  9. * Currently enrolled in other cognitive therapy that cannot be discontinued.
  10. * Does not speak English fluently.
  11. * Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation).
  12. * 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.

Contacts and Locations

Study Contact

Margaret H McCallum
CONTACT
(352) 376-1611
Margaret.McCallum@va.gov
Yi Zhang, PhD
CONTACT
(352) 548-6000
yizhang@ufl.edu

Principal Investigator

Julia K. Waid-Ebbs, PhD
PRINCIPAL_INVESTIGATOR
North Florida/South Georgia Veterans Health System, Gainesville, FL

Study Locations (Sites)

North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Julia K. Waid-Ebbs, PhD, PRINCIPAL_INVESTIGATOR, North Florida/South Georgia Veterans Health System, Gainesville, FL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01
Study Completion Date2026-10-31

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2026-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Brain Injury
  • Cognition
  • PTSD
  • Intervention