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NCT05380050

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

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from VA Office of Research and Development

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Record History

All 7 versions: 6 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Oct 29, 2027
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 5 entries
  2. Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Study description revised
    • Site details revised
  3. Site contact updatedv5
  4. Site details revisedv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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 (5)

Change in the Test of Grocery Shopping Skills
Change in the attention index of the Repeatable Battery for the Assessment of Neuropsychological Status
Change in Attention Network Task
Change in Traumatic Brain Injury-Quality of Life, Participation Ability and Satisfaction short-form
Change in the Unstructured Task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research

Arms and interventions

Inpatient GMT plus Attention TrainingExperimental

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.

Telehealth GMT plus Attention TrainingExperimental

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

Brain Health WorkshopPlacebo 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: Goal Management Training plus Attention Training, Brain Health Workshop and National Geographic Movies

Sites

1 site in 1 country

  • North Florida/South Georgia Veterans Health System, Gainesville, FLGainesville, Florida, United States