Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

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.

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.

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.

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

See Outcome 8 for description of VOMS test.

Convergence is also assessed in the VOMS using objective measurement of the near point of convergence (NPC). It is averaged across 3 trials, and recorded in centimeters (cm). NPC values >5 cm reflect a positive clinical screening.

Scores will be compared between Baseline and 4-week visits

The mBESS measures postural stability and consists of three stances including feet side by side, a tandem stance, and a single-leg stance on the non-dominant leg. The three stances are performed for 20 seconds each on a firm surface. All stances are completed with eyes closed and with hands on the iliac crests. Errors include lifting hands off the iliac crests, opening the eyes, stepping, stumbling, falling, moving the hips more than 30 degrees of flexion or abduction, lifting the forefoot or heel, or remaining out of the testing position for more than 5 seconds. Each error equals 1 point, with higher scores indicating worse performance. For the current study, the modified BESS (mBESS) on the firm surface only will be used. Clinical cut-offs for mBESS suggest a total error of 9 or greater indicate clinical impairment in balance. The mBESS takes approximately 5-6 minutes to administer. mBESS scores will be analyzed at each timepoint and over time.

The PHQ-9 is a 9 item questionnaire that assesses the presence and severity of depression. Total score ranges from 1-27, with higher scores indicating higher level of depression. Scale is 0-4 (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day). PHQ-9 total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.

The DSM-CCSM-A is a 23-item self-report measure designed to evaluate overall and co-occurring psychological health symptoms including depression, anger, mania, anxiety, somatic symptoms, sleep disturbance, psychosis, obsessive thoughts/behaviors, substance use, personality function, dissociation, cognition, and suicide. The DSM-CCSM-A is commonly used to track therapeutic response to interventions. All items except for the three suicide-related items are rated 0-none to 4-severe/almost daily. Items scored at 2 or greater indicate important levels of symptoms that require further assessment. Scores range from 0-88. Scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.

The PCL-5 is a 20-item self-report questionnaire corresponding to the DSM-5 symptom criteria for PTSD. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms. The items are rated on a 5-point Likert scale, 0-4 for each symptom, and summed for a total severity score ranging from 0-80. Total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.

The WHODAS 2.0 Measures average functioning in everyday situations over the last 30 days, and surveys six domains of functioning (cognition, mobility, self-care, getting along with others, life activities and participation. The modified version will be used in this study. It contains 12 items rated on a 5-point scale 0-4, with summary score of 0-100 (where 0 = no disability; 100 = full disability). Total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.

The AAQ-II is a 7-item self-report questionnaire with items rated on a 7-point Likert scale 1-7 (1=Never true to 7=Always true). It is used to measure an individual's behaviors regarding their ability to process feelings, emotions, and worries. It is often used to measure progress in Acceptance and Commitment Therapy. Higher total scores indicate higher psychological inflexibility, experiential avoidance, and more potential psychological distress. Total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.

The WSAS assesses the impact of a person's mental health difficulties on their ability to function in terms of work, home management, social leisure, private leisure and personal or family relationships. It is a 5-item self-report questionnaire on a 9-point Likert scale 0-8 (0=Not at all; 8=Very Severely). Higher scores indicate greater difficulty. Total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.

The PGIC was developed for self-reported assessment of change resulting from post-concussion care at military treatment facilities. The prompt is: ""Since beginning treatment at this facility, how would you describe the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS and OVERALL QUALITY OF LIFE related to your post-concussive condition?"" The participant responds on a scale ranging from 0 (No change or condition has gotten worse), to 7 (A great deal better and a considerable improvement that has made all the difference). Lower scores indicate worse recovery. Total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.

For civilians, return to activity (RTA) will be medical clearance to resume full activities without limitations based on symptom and impairment free at rest, and symptom free following standardized exertion protocols per recent consensus. Return to duty (RTD) will be determined based on: Not returned to duty/Returned to duty with restrictions/Returned to duty without restrictions.

Description of test: The I-PAS is a portable, 3-D virtual reality (VR)-based, video-oculographic test device to evaluate vestibulo-ocular function. The goggles are placed on the head of participants who are then asked to follow the instructions on the VR display. A series of vestibulo-ocular tests are performed, and data is recorded via laptop interface. Participants will perform the following static and dynamic vestibular tests: spontaneous nystagmus, gaze nystagmus, positional, sinusoidal harmonic acceleration (SHA), SHA with visual enhancement and suppression; head impulse tests; as well as vestibulo-ocular and oculomotor tests including: smooth pursuits, vergence pursuit, vergence steps, predicted saccades, anti-saccades, visual vertical and horizontal, visual reaction time, and dual eye movement/motor tasks.

The eye movements of each tested are recorded, and the changes in movement will be assessed from baseline to 4-week.

Please see description of I-PAS test in Outcome 19.

Symptom severity will be rated 0 (none) to 10 (severe) for headache, nausea, dizziness, and fogginess before and after the I-PAS testing procedures. The totals will be compared from the beginning of the test to after, as well as between visits.

At Baseline, the study team will provide all participants with a Fitbit Inspire 3 (or similar device depending on market availability) physical activity tracker to wear and sync with participant's cell phones for the duration of the 4-week intervention period. The activity monitoring will provide confirmatory evidence of compliance via real-time monitoring of physical activity and sleep behaviors.

The study team will download the Fitbit data collected, such as (but not limited to) step counts, heart rate, sleep, and daily activity across each day of the 4-week intervention period from Fitabase.

See Outcome 22 for description of Fitbit

Daily step counts will be recorded.

See Outcome 22 for description of Fitbit

Daily heart rate (HR) measured as beats per minute will be recorded. This will include daily average, hour average, and minute average.

See Outcome 22 for description of Fitbit

Daily sleep information will be recorded. For each day/night of sleep, the following will be recorded: 1)minutes asleep, 2) minutes after wakeup, 3) minutes to fall asleep, 4) minutes of time in bed.

See Outcome 22 for description of Fitbit

Daily activity information will be recorded. For each day of activity, the following is recorded: 1)distance walked (miles), 2) time of activity (minutes), 3) calories burned

The PEG includes 3 items assessing pain intensity and functional interference with enjoyment of life and general activity. It is scored by averaging the items; scores range from 0-10, with higher scores indicating higher pain intensity. Total scores will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.