Goal-oriented Telehealth Rehabilitation of Executive Functioning for Veterans With Chronic TBI
GOALS TH
Goal-oriented Rehabilitation of Executive Functioning Using Video-telehealth to Improve Community Reintegration for Veterans With Chronic TBI and Cognitive Difficulties
2 other identifiers
interventional
80
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2025
CompletedFirst Posted
Study publicly available on registry
September 24, 2025
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2030
January 9, 2026
January 1, 2026
4 years
September 5, 2025
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurocognitive performance -Overall Attention and Executive Function (AEF) Z score
Performance on neurocognitive composite measure of attention and executive function post intervention vs control training will be assessed with Overall Attention and Executive Function (AEF) domain composite Z Score (calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching). AEF Z score range is -3 to +3; higher score = better outcome.
Baseline, 10 week (post training), 6 month
Secondary Outcomes (2)
Functional outcomes - Mayo Portland Adaptability Inventory (MPAI) T score
Baseline, 10 week (post training), 6 month
Emotional regulation- Profile of Mood States (POMS) Z score
baseline, 10 week (post training), 6 month follow up
Study Arms (2)
GOALS TH
EXPERIMENTALThe 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
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- History of mild to moderate TBI \> 6 months ago
- Cognitive difficulties affecting daily functioning
- Age 18-65
- Veteran
- At least 12th grade education or equivalent \* Interested in improving community reintegration
You may not qualify if:
- Amnesic/Severe memory problems
- Active Substance Abuse/Dependence
- Medical condition that may affect mental status/disrupt study participation
- Active psychotropic medication changes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Tatjana Novakovic-Agopian, PhD
VA Palo Alto Health Care System, Palo Alto, CA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Blinded assessor
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2025
First Posted
September 24, 2025
Study Start
April 1, 2026
Primary Completion (Estimated)
March 30, 2030
Study Completion (Estimated)
March 30, 2030
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
Electronic datasets underlying publications will be de-identified and anonymized. Limited datasets without individually identifiable data will be maintained locally on VA protected servers until the appropriate data use agreements are in place.