Clinical trial NCT05913505: Heart Rate Variability Biofeedback Following Traumatic Brain Injury
Official title: A Randomized Controlled Trial of Heart Rate Variability Biofeedback Following Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Traumatic Brain Injury
Lead sponsor: Brigham Young University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twenty-five participants will complete the treatment condition in a pseudo-randomized order (determined by random number generator with constraints) such that half of the participants will be given the heart rate variability biofeedback active condition and half will be given the sham control condition. However, the participants in the sham control condition will be offered treatment with heart rate variability biofeedback after study completion. The heart rate variability biofeedback active condition is designed to increase heart rate oscillations (Osc+ condition) consistent with current best practices, while the sham control heart rate variability biofeedback condition is designed to decrease heart rate oscillations (Osc- condition).
Primary purpose: TREATMENT

Brief summary: Individuals with mild traumatic brain injury will be randomly assigned to an active heart rate variability biofeedback condition and a sham condition. The investigators will use a randomized pre-post design that will consist of two data collection phases and a 5-week treatment condition. The heart rate variability biofeedback active condition is designed to increase heart rate oscillations (Osc+ condition) consistent with current best practices, while the sham control heart rate variability biofeedback condition is designed to decrease heart rate oscillations (Osc- condition).

Detailed description: There are two primary aims of the study: (1) examine whether heart rate variability increases at rest in individuals with mild traumatic brain injury from pre-treatment to post-treatment following heart rate variability biofeedback; (2) to test whether heart rate variability recovery following a stressor improves in individuals with mild traumatic brain injury following heart rate variability biofeedback. Regarding the first primary aim, the investigators hypothesize that heart rate variability will be higher in individuals with mild traumatic brain injury following heart rate variability biofeedback compared to those in the control/sham condition where the investigators do not expect such improvement pre- to post-testing. For the second aim, consistent with previous work, the investigators hypothesize that heart rate variability recovery following a stressor will be faster in individuals with mild traumatic brain injury following heart rate variability biofeedback compared to a sham control condition. There are three secondary aims for this study: (1) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in physical symptoms common after head injury (i.e., headaches, dizziness, sleep disturbance); (2) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in emotional functioning (i.e., life satisfaction, anxiety symptoms, depression symptoms); and (3) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in cognitive functioning (i.e., attention, inhibitory control).

Eligibility criteria: Inclusion Criteria:

* At least six months post-injury to account for spontaneous recovery
* Aged 18-55 years
* Fluent in English
* Able to provide informed consent.

Exclusion Criteria:

* Presence of a pacemaker
* Previous self-reported heart attack with hospitalization
* Diagnosed learning disability
* Other neurological difficulties or diagnoses (i.e., stroke, epilepsy)
* Participation in current litigation
* Uncorrected visual impairment.

Primary outcomes:
measure: Stress Recovery
timeFrame: Through study completion, an average of 7 weeks
measure: Resting HRV
timeFrame: Through study completion, an average of 7 weeks
Secondary outcomes:
measure: Physical Symptoms
timeFrame: Through study completion, an average of 7 weeks
measure: Scale of Positive and Negative Experience
timeFrame: Through study completion, an average of 7 weeks
measure: Depression Anxiety Stress Scales
timeFrame: Through study completion, an average of 7 weeks
measure: Satisfaction with Life Scale
timeFrame: Through study completion, an average of 7 weeks
measure: Cognitive Functioning
timeFrame: Through study completion, an average of 7 weeks
Other outcomes:
Locations:
city: Provo
country: United States
facility: Brigham Young University
state: Utah
Study officials:
affiliation: Brigham Young University
name: Michael J Larson, PhD
role: STUDY_CHAIR
References: