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

NCT05380050 | Recruiting

• 1 other identifier: N3984-R
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Injury; Cognition; PTSD; Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in the Test of Grocery Shopping Skills

  week 1, week 11

• Change in the attention index of the Repeatable Battery for the Assessment of Neuropsychological Status

  week 1, week 11, week 35 and week 59

• Change in Attention Network Task

  week 1, week 11, week 35 and week 59

• Change in Traumatic Brain Injury-Quality of Life, Participation Ability and Satisfaction short-form

  week 1, week 11, week 35 and week 59

• Change in the Unstructured Task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research

  week 1, week 11, week 35 and week 59

Study Arms (3)

Inpatient GMT plus Attention Training

EXPERIMENTAL

Goal Management Training is a group metacognitive intervention to improve ability to complete complex task more effectively. 2-hour session are conducted in-person weekly over 10-weeks. A second weekly session includes Attention training which is conducted one-on-one with the therapist in the clinic. Participant completed 5-6 hours of homework between sessions.

Behavioral: Goal Management Training plus Attention Training

Telehealth GMT plus Attention Training

EXPERIMENTAL

Goal Management Training is a group metacognitive intervention to improve ability to complete complex task more effectively. 2-hour session are conducted over the VA VideoConnect weekly over 10-weeks. A second weekly session includes Attention training which is conducted one-on-one with the therapist via VA VideoConnect. Participant completed 5-6 hours of homework between sessions

Behavioral: Goal Management Training plus Attention Training

Brain Health Workshop

PLACEBO COMPARATOR

Brain Health Workshop includes educational information about the brain to control for GMT and National Geographic Movies is used as a control to equate time with therapist in Attention Training. Each session occurs weekly for 2-hours over 10-weeks.

Behavioral: Brain Health Workshop and National Geographic Movies

Interventions

Goal Management Training plus Attention Training BEHAVIORAL

GMT is a Power Point directed interactive group training to use a five point strategy to plan and execute complex tasks. Attention Training utilizes Brain HQ attention modules and individualized attention goals.

Also known as: GMT + ATT

Inpatient GMT plus Attention Training; Telehealth GMT plus Attention Training

Brain Health Workshop and National Geographic Movies BEHAVIORAL

BHW is a Power Point directed interactive training to learn about the brain and cognitive components. National Geographic Movies, participants select movies to watch with the therapists and answers questions regarding the content.

Also known as: BHW and National Geographic Movies

Brain Health Workshop

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608-1135, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Julia K. Waid-Ebbs, PhD

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret H McCallum

CONTACT

(352) 376-1611; Margaret.McCallum@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor is not involved in treatment and is blind to group enrollment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 63 randomized to three groups: In-patient intervention, Telehealth intervention and Control

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)