Heart Rate Variability Biofeedback Following Traumatic Brain Injury

NCT ID: NCT05913505

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2024-04-24

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).

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OSC+

Twenty-five participants will complete five weeks of heart rate variability biofeedback using emWave software (HeartMath®Institute, 2020). Participants will receive a weekly 30-minute heart rate variability biofeedback session for five weeks at the University Parkway Center, Brigham Young University. The heart rate variability biofeedback protocol will be based on Lehrer et al., 2013 and Yoo et al., 2022. This format will aid participants in implementing and learning breathing and heart rate variability biofeedback skills (Lehrer et al., 2020). All participants will wear an ear sensor to measure their pulse. The heart rate variability biofeedback will focus on autonomic balance through slow breathing at a resonance frequency of approximately 6 breathes per minute. The best approximate breathing pace for resonance frequency will be estimated and participant's resonance frequency will be provided and used for their homework and subsequent training sessions.

Group Type: EXPERIMENTAL

OSC+

Intervention Type: BEHAVIORAL

The first session of the HRVB intervention will focus on introducing the client to HRVB and calculating the participant's resonance frequency which typically range from 4.5-7 breaths per minute. Participants will first complete a five-minute baseline breathing condition. Following the breathing condition, the participants will complete five conditions for five minutes each. Specifically, each condition will have the person breath at 6, 6.5, 5.5, 5, and 4.5 breaths per minute with a minute break between. Session two will focus on practicing resonance frequency breathing and solidifying the correct resonance frequency for the participant. Additionally, this session will introduce the technique of breathing through pursed lips and abdominal breathing. For sessions three through five, participants will practice resonance frequency breathing and review previous strategies.

OSC-

Twenty-five participants will complete five weeks of Osc-. Similarly, for the Osc- procedures, the client will be required to complete a five-week intervention. During the weekly session, participants will also be wearing an earlobe monitor with HeartMath. Participants will be administered the Scale of Positive and Negative Experience at the beginning of each session to assess for mood. Participants will also be administered the 3-item Rivermead Post Concussion Symptoms Questionnaire at the beginning of each session. Participants will be instructed that the purpose of this portion of the study is to decrease their breathing oscillations. A program was designed by Yoo and colleagues (2022) that gives feedback regarding a "calmness" score which reflects a better score (i.e., higher) when participants breath in a pattern that elicits less variability (i.e., less oscillations).

Group Type: SHAM_COMPARATOR

OSC-

Intervention Type: BEHAVIORAL

During the first week, the baseline will be assessed and resonance frequency. Specifically, during their first intervention session the participants will be told that the goal of the sessions includes decreasing heart rate variability and avoiding slow and steady breathing. The participants will then be asked to choose five strategies to lower their heart rate oscillations. Participants will be told to avoid slow breathing as it causes large heart rate oscillations. For the second session, the therapist will check in with the participant and discuss how the practice went. Participants will then select three strategies that they will practice for three five-minute conditions following a five-minute baseline. Sessions three, four, and five will include three conditions: a five-minute baseline and two strategies of their choice. For each session, the best strategy will be calculated and written on the assignment sheets to be used during the week for their four homework sessions.

Interventions

OSC+

The first session of the HRVB intervention will focus on introducing the client to HRVB and calculating the participant's resonance frequency which typically range from 4.5-7 breaths per minute. Participants will first complete a five-minute baseline breathing condition. Following the breathing condition, the participants will complete five conditions for five minutes each. Specifically, each condition will have the person breath at 6, 6.5, 5.5, 5, and 4.5 breaths per minute with a minute break between. Session two will focus on practicing resonance frequency breathing and solidifying the correct resonance frequency for the participant. Additionally, this session will introduce the technique of breathing through pursed lips and abdominal breathing. For sessions three through five, participants will practice resonance frequency breathing and review previous strategies.

Intervention Type: BEHAVIORAL

OSC-

During the first week, the baseline will be assessed and resonance frequency. Specifically, during their first intervention session the participants will be told that the goal of the sessions includes decreasing heart rate variability and avoiding slow and steady breathing. The participants will then be asked to choose five strategies to lower their heart rate oscillations. Participants will be told to avoid slow breathing as it causes large heart rate oscillations. For the second session, the therapist will check in with the participant and discuss how the practice went. Participants will then select three strategies that they will practice for three five-minute conditions following a five-minute baseline. Sessions three, four, and five will include three conditions: a five-minute baseline and two strategies of their choice. For each session, the best strategy will be calculated and written on the assignment sheets to be used during the week for their four homework sessions.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham Young University

OTHER

Sponsor Role: lead

Responsible Party

Leah Talbert

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael J Larson, PhD

Role: STUDY_CHAIR

Brigham Young University

Locations

Brigham Young University

Provo, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leah D Talbert, MS

Role: CONTACT

leah.d.whitlow@gmail.com

3343141078

Michael J Larson, PhD

Role: CONTACT

michael_larson@byu.edu

8014226125

Facility Contacts

Michael J Larson, PhD

Role: primary

michael_larson@byu.edu

801-422-6125

Leah D Talbert, MS

Role: backup

leah.d.whitlow@gmail.com

3343141078

Other Identifiers

TBI_HRVB

Identifier Type: -

Identifier Source: org_study_id