Health TrialsbyHealthPanel

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

ConditionsConcussion, MildMild Traumatic Brain Injury (mTBI)Psychological Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-49
SponsorUniversity of Pittsburgh

About this trial

The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Rehabilitation (ACT) with usual care rehabilitation (CONTROL) in 250 individuals with mTBI-related symptoms attributable to mild traumatic brain injury (mTBI) treated at one of two sites (1) the University of Pittsburgh Medical Center, or (2) the Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Hood, Texas. Both interventions will be delivered weekly over 4 weeks. Assessments will be administered prior to the start of treatment (Baseline) and at 4-weeks, 3- and 6-months following the completion of treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-49 years of age

Normal/corrected vision

Diagnosed with mTBI per military clinical practice guidelines (CPGs) that occurred over 8 days prior to consent as determined by a multi-domain assessment performed by a licensed healthcare professional.

mTBI-related symptoms and/or impairments in at least one or more areas, including vestibular (dizziness, imbalance), psychological health (anxiety, depression, stress), cognitive (memory problems), headache/migraine, ocular, or sleep. as determined by self-report.

Disqualifiers

History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction) as determined by patient self-report.

History of neurological disorder (e.g., epilepsy, multiple sclerosis) as determined by self-report.

Cervical spine injury or dysfunction (i.e., limited range of motion; ROM) as determined by self-report.

Previous moderate to severe TBI as determined by self-report.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acceptance and Commitment Therapy Integrated Rehabilitation (ACT)

    Behavioral

    Participants will receive the ACT treatment. It is comprised of three processes: Open Up, Be Present, and Do What Matters. Each of these is further sub-divided, for a total of six core processes. These processes include, but are not limited to, present moment awareness, de-fusion, and committed action. This group will also receive targeted vestibular therapy and standardized behavioral management strategies (physical activity, sleep, hydration, and nutrition prescription). Participants will also receive usual care at the discretion of each site's treating providers.

  • Usual Care Rehabilitation

    Behavioral

    Participants will receive usual care treatment at the discretion of each site's treating providers, excluding any components associated with ACT. Because usual standard of care is individualized to the patient's unique functional deficits, treatments may focus on any one or more of the following: vestibular rehabilitation, neuro-optometry, neuropsychology, physical and occupational therapy, or speech and language pathology, or general mental health interventions.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Acceptance and Commitment Therapy Integrated Rehabilitation (ACT)Experimental treatment 2 interventions
Group B: Usual Care Rehabilitation (CONTROL)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Generalized Anxiety Disorder (GAD-7)

The GAD-7 is a seven item self-reported questionnaire that measures severity of symptoms regarding anxiety. Responses are 0 = not at all, 1 = several days, 2= more than half the days, and 3 = nearly every day. Higher scores are indicative of higher anxiety (0-4 = minimal anxiety, 5-9= mild anxiety, 10-14 =moderate anxiety, 15-21 = severe anxiety.

Time frame
Baseline, 4-week, 3-month, 6-month study visits
2

Neurobehavioral Symptom Inventory (NSI)

The NSI is a 22-item symptoms scale in which participants rate the severity of symptoms on a 5-point scale (0=none, 1= mild, 2=moderate, 3=severe, 4=very severe) Scores range from 0 to 60. The NSI takes approximately 5-10 minutes to administer. NSI total score changes will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.

Time frame
Baseline, 4-week, 3-month, 6-month study visits

Secondary outcomes

1

Ohio State University TBI Identification short form (OSU TBI-ID)

The OSU TBI-ID is a standardized form that collects lifetime instances of brain injuries via a 3-5 minute structured interview. For each past reported instance of a brain injury, the form collects the mechanism of injury, the occurrence of loss of consciousness (yes/no), duration of loss of consciousness (\< 30 mins, 30min-24hr, \>30 min), became dazed or experienced a memory gap, and age at injury.

Time frame
Baseline
2

Dizziness Handicap Inventory (DHI)

The DHI is a 25-item self-report measure that examines dizziness-related handicap. Each item is categorized into one of three domains: functional, emotional, or physical. The DHI was developed with the help of patients who complained of dizziness and uses a three-item response scale (Yes, Sometimes, No) scored as 4/2/0, respectively. Score range: 0-100, with higher scores indicating worse dizziness.

Time frame
Baseline, 4-week, 3-month, 6-month study visits
3

Concussion Clinical Profiles Screening (CP-Screen)

The CP Screen is a 29 item self-report, clinical profiles based symptom inventory that measures five concussion clinical profiles: 1) anxiety/mood, 2)cognitive/fatigue, 3) migraine, 4) ocular, 5) vestibular; and two modifying factors sleep and cervical. Participants indicate on a scale of 0 (none) to 3 (severe) the level of symptom severity for each item. The CP screen yields an average factor and modifier scores, with higher scores indicative of worse symptom severity, score range is 0-87.

Time frame
Baseline
4

Vestibular/Ocular Motor Screening (VOMS) - Change from Baseline in Symptom Reporting at 4-weeks

The VOMS assesses impairment via patient-reported symptom provocation following each of the following items: 1) smooth pursuits; 2) horizontal and vertical saccades; 3) convergence; 4) horizontal and vertical ocular reflex (VOR); and 5) visual motion sensitivity (VMS). Patients rate their symptom severity in headache, dizziness, nausea, and fogginess compared to their immediate pre-assessment state on a scale of 0 (none) to 10 (severe) to determine if any VOMS item provokes the symptoms. Scores on any symptom of 2 or greater reflects a positive screening cut-off for vestibular or oculomotor impairment. Total symptom scores are recorded for each symptom. Scores will be compared between Baseline and 4-week visits

Time frame
Baseline, 4-week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
Apply now