CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 169 enrolled
Drug / intervention
Targeted Multidomain +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04549532
NCT04549532N/ACompleted
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Multisite Randomized Controlled Trial of Targeted Multidomain (T-MD) Interventions for Complex Mild Traumatic Brain Injury (mTBI)

University of Pittsburgh·interventional·Posted Sep 16, 2020·Updated Oct 9, 2025

In Brief

A clinical study evaluating Targeted Multidomain and Behavioral Management for Concussion, Mild. Completed, enrolled 169 participants across 2 sites.

Detailed Summary

Objective: This 3-year multisite RCT will determine the effectiveness of a targeted multidomain intervention (T-MD) (anxiety/mood, cognitive, migraine, ocular, vestibular; and sleep, autonomic) compared to usual care (behavioral management) in military-aged civilians with complex mTBI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConcussion, Mild
CountriesUnited States
CollaboratorsInova Health Care Services, United States Department of Defense

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 16, 2020
Enrollment StartJun 15, 2021
Primary CompletionApr 30, 2024
Study CompletionApr 9, 2025
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.8 years ago

Interventions

Targeted Multidomainbehavioral

Participants in the T-MD intervention group will be prescribed targeted interventions to address each individual's symptoms, impairments, and functional limitations in the areas of anxiety/mood, cognitive, migraine/headache, ocular, vestibular, sleep, autonomic. The length of the intervention period will be 4 weeks or until RTA, whichever comes first.

Behavioral Managementbehavioral

1.3. Usual Care (Controls) Group Participants randomized to the usual care (control) group will receive standardized (i.e., all participants in this group will receive the same interventions) behavioral management strategies that include activity, hydration, nutrition, sleep, and stress management strategies.