Goal-oriented Telehealth Rehabilitation of Executive Functioning for Veterans With Chronic TBI

Part of paid clinical trials in Palo Alto, California.

Sponsor
VA Office of Research and Development
Study ID
NCT07190365
Status
Recruiting
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Conditions

  • Cognitive Rehabilitation
  • Mild to Moderate Traumatic Brain Injury
  • Veteran

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • GOALS TH — BEHAVIORAL
    The Goal-Oriented Attentional Self-regulation training involves ten 2-hour sessions of group-based telehealth training, three individual 1-hour telehealth training sessions, and approximately 20 hours of home practice. It is conducted in a small group format.
  • EDU TH — BEHAVIORAL
    The EDU TH training is an active control training matched with GOALS TH for therapist time, homework load, and participation in a group. It involves ten 2-hour telehealth sessions of group-based training, three individual 1-hour telehealth training sessions, and approximately 20 hours of home practice.

Study Details

Provision of interventions that address cognitive and emotional problems faced by Veterans with history of TBI pursuing community reintegration is an important concern for VA. Using telerehabilitation, the current project will help determine whether goal-directed training of attentional control functions via personally relevant activities will improve community integration for Veterans with history of TBI and cognitive difficulties. Findings may guide rehabilitation training towards providing services to maximize success in attaining complex functional goals in which Veterans can engage in skill strengthening 'where they are' (any location).

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Mar 30, 2030
Completion
Mar 30, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GOALS TH
    The Goal-Oriented Attentional Self-regulation training involves ten 2-hour sessions of group-based telehealth training, three individual 1-hour telehealth training sessions, and approximately 20 hours of home practice. It is conducted in a small group format.
  • Active Comparator: EDU TH
    The EDU TH training is an active control training matched with GOALS TH for therapist time, homework load, and participation in a group. It involves ten 2-hour telehealth sessions of group-based training, three individual 1-hour telehealth training sessions, and approximately 20 hours of home practice.

Primary Outcome Measure

Neurocognitive performance -Overall Attention and Executive Function (AEF) Z score [ Time Frame: Baseline, 10 week (post training), 6 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care System, Palo Alto, CAPalo AltoCalifornia94304-1207
Aman Kumar
[email protected]
650-493-5000
Geoffrey W Goodale, BS
[email protected]
(518) 626-5626
Tatjana Novakovic-Agopian, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
VA Palo Alto Health Care System, Palo Alto, CA· Palo Alto, CA

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