Clinical trial NCT05380050: Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD
Official title: Comparing the Effectiveness of Telehealth to In-person Delivery of a Combined Metacognitive and Attention Training in Veterans With mTBI/PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Injury
Cognition
PTSD
Intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-05-18
Enrollment: 63
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 63 randomized to three groups: In-patient intervention, Telehealth intervention and Control
Primary purpose: TREATMENT

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.

Detailed description: Background. Over 70% of Veterans with mild traumatic brain injury (mTBI), seeking services at the Veterans' Health Administration, suffer from comorbid post-traumatic stress disorder (PTSD). These Veterans commonly experience concomitant executive dysfunction in goal setting, concentration, and attention that impairs their performance in complex daily tasks. Others and the investigators have studied Goal Management Training (GMT) to address this problem. Collectively, the data have shown that GMT improved some aspects of executive function in mTBI/PTSD but did not restore cognition to normal during complex tasks. Goal management for performing complex tasks requires cognitive processes such as attention, and direct-attention training may be beneficial in improving cognition. GMT with attention training have been used in other studies, but those did not involve Veterans with either mTBI or mTBI/PTSD. The investigators recently conducted a pilot study combining GMT and direct-attention training (GMT+ATT) in Veterans with mTBI and PTSD. The investigators discovered a large treatment effect (Cohen d=2.23) in the NIH EXAMINER Executive Composite score and a significant treatment response in the NIH EXAMINER Cognitive Control subdomain and the Unstructured Task.

GMT or ATT is typically administered in-person. In-person treatment can impose problems such as limited treatment access, poor cost-effectiveness, and unexpected situations (like the COVID-19 pandemic). As an alternative method, telehealth has been used increasingly to meet the need for care in Veterans living in rural areas and during the pandemic. Telehealth delivery of cognitive interventions in Veterans with mTBI or with PTSD has shown effectiveness that is comparable to that of in-person treatment. However, GMT+ATT has not been studied in these Veterans. Therefore, the investigators have recently developed the format for telehealth delivery of GMT+ATT in Veterans with mTBI/PTSD. The preliminary data demonstrate the feasibility of this delivery platform and similar treatment outcomes as compared to in-person therapy.

Objective \& Hypotheses. The objective of this randomized controlled trial is to determine and compare the effect of in-person and telehealth delivery of GMT+ATT in Veterans with mTBI/PTSD.

Hypothesis 1a. In-person GMT+ATT will improve cognition vs. control group (Brain Health Workshop (BHW).

Hypothesis 1b. Telehealth GMT+ATT will improve cognition vs. BHW control group Hypothesis 2. Telehealth delivery of GMT+ATT will produce response comparable to in-person treatment. Primary measure. The NIH EXAMINER executive composite score will assess overall executive function with subdomains such as complex task performance requiring goal management, as well as tests underlying cognitive control such as attention and working memory. Secondary functional measures. 1) Unstructured Task and 2) Test of Grocery Shopping Skills (ToGSS), which captures naturalistic real-world function. Exploratory Objective. To study the capability of the Attention Network Task to predict treatment response to GMT+ATT.

Methods. 63 Veterans will be randomized to 10 weeks of in-person or telehealth delivery of GMT+ATT or BHW control. Outcomes will be assessed at pre-, post-, 6 month-post and 1-year post-treatment. GMT and ATT will each be provided in ten, weekly, 2-hour sessions (4hrs/week as combined).

Significance. This study uses a novel combinational treatment of GMT+ATT to restore the executive and attentional processes required for complex daily tasks in Veterans with mTBI/PTSD. This work meets a key VA RR\&D priority of providing quality care to Veterans. Positive study results may help shape clinical practice of cognitive rehabilitation in terms of treatment strategy, delivery platform, access to care, and means to predict treatment response. Such impacts will translate to significant cost-savings for the VA healthcare system and improvement in quality of life in Veterans.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Composite Executive score of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research
timeFrame: pre-intervention, post, 6-month and 1-year follow-up
Secondary outcomes:
measure: Change in the Test of Grocery Shopping Skills
timeFrame: week 1, week 11
measure: Change in the attention index of the Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: week 1, week 11, week 35 and week 59
measure: Change in Attention Network Task
timeFrame: week 1, week 11, week 35 and week 59
measure: Change in Traumatic Brain Injury-Quality of Life, Participation Ability and Satisfaction short-form
timeFrame: week 1, week 11, week 35 and week 59
measure: Change in the Unstructured Task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research
timeFrame: week 1, week 11, week 35 and week 59
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: Julia K. Waid-Ebbs, PhD
role: PRINCIPAL_INVESTIGATOR
References: