Goal-oriented Telehealth Rehabilitation of Executive Functioning for Veterans With Chronic TBI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVA Office of Research and Development
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
History of mild to moderate TBI > 6 months ago
Cognitive difficulties affecting daily functioning
Age 18-65
Veteran
Disqualifiers
Amnesic/Severe memory problems
Active Substance Abuse/Dependence
Medical condition that may affect mental status/disrupt study participation
Active psychotropic medication changes
Trial design
Design model
Parallel
Treatments tested in this trial
GOALS TH
BehavioralThe 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
BehavioralThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: GOALS THExperimental treatment 1 intervention
Group B: EDU THActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 10 week (post training), 6 monthSecondary outcomes
1
Functional outcomes - Mayo Portland Adaptability Inventory (MPAI) T score
Performance on self-report measure of functional performance in daily life post intervention vs control training will be assessed with May Portland Adaptability Inventory (MPAI)- Total Score. MPAI Total T Score range is 20-80; higher score =worse outcome
Time frame
Baseline, 10 week (post training), 6 month2
Emotional regulation- Profile of Mood States (POMS) Z score
Performance on self report measures of emotional regulation post intervention vs control training Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance (TMD) Z Score. POMS Total Mood disturbance Z score range is -3 to +3; higher score = better outcome.
Time frame
baseline, 10 week (post training), 6 month follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
VA Palo Alto Health Care System
Collaborator
Source ClinicalTrials.gov