Evaluating the Feasibility, Acceptability, and Preliminary Outcomes of Heart Rate Variability Biofeedback for Individuals With Opioid Use Disorder.

Arizona State University (ASU)

Status

Invitation-only

Conditions

Breathing Techniques

Autonomic Nervous System Imbalance

Opioid Craving

Opioid Use Disorder

Emotional Regulation

Positive and Negative Affect

Heart Rate Variability (HRV)

Biofeedback

Recovery

Stress

Treatments

Behavioral: Heart rate variability biofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT07361731

STUDY00022883

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary outcomes of a heart rate variability biofeedback (HRVB) intervention among adults with opioid use disorder (OUD) receiving residential treatment. The study aims to learn whether HRVB can be implemented successfully in this setting and whether it may help participants manage stress, emotional regulation, and cravings.

The main questions this study aims to answer are:

Is HRVB feasible and acceptable for adults with OUD in a residential treatment program, as indicated by recruitment, retention, adherence, and participant satisfaction?

Do participants show preliminary improvements in stress, affect, emotional regulation, self-efficacy, and cravings following participation in the HRVB intervention?

Participants will be adults with OUD enrolled in a residential treatment program.

Participants will:

Complete baseline and post-intervention questionnaires assessing stress, affect, emotional regulation, social support, self-efficacy, and cravings
Participate in daily HRVB practice using a portable biofeedback device for approximately 3 weeks
Complete brief daily diary assessments related to mood, stress, and cravings

This is a single-arm pilot study designed to inform the feasibility and future refinement of HRVB as an adjunct intervention for individuals with OUD in residential treatment settings.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Eligible participants are
1. adults aged 18 to 65,
2. currently admitted to a transitional living program for opioid use and within the first 30 days of admission
3. voluntarily agree to participate and demonstrate adequate decision-making capacity as determined by the study team during informed consent
4. able to read and speak English,
5. have a clinical diagnosis of OUD at any severity level, whether mild, moderate, or severe,
6. identify opioids as their primary drug of choice
7. should have access to smartphones for daily individual practice of the intervention.
8. must reside at the treatment program for the duration of the study

Exclusion criteria

inability to provide informed consent,
inability to demonstrate adequate decision-making capacity
currently having suicidal thoughts or psychotic symptoms
history of receiving previous HRVB training,
have a serious cardiac condition such as having pacemaker, heart failure or cardiac arrhythmia),
a known self-reported diagnosis of dementia, a severe brain injury, or a serious neurological condition(e.g., Parkinson's disease)
currently enrolled in any other biofeedback program simultaneously
currently taking medications such as MAOIs and alpha/beta blockers or benzodiazepines.

Participant recruitment will be conducted at the recruitment site. Individuals younger than 18 or older than 65 years are excluded from participation primarily due to age-related differences in autonomic function and heart rate variability (HRV) regulation. Restricting the sample to adults aged 18-65 allows for more accurate measurement and interpretation of HRV data, thereby reducing potential confounding effects related to age-related physiological differences.