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

Summary

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:

1. Complete baseline and post-intervention questionnaires assessing stress, affect, emotional regulation, social support, self-efficacy, and cravings
2. Participate in daily HRVB practice using a portable biofeedback device for approximately 3 weeks
3. 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.

Conditions

• Autonomic Nervous System Imbalance
• Heart Rate Variability (HRV)
• Opioid Use Disorder
• Breathing Techniques
• Opioid Craving
• Recovery
• Emotional Regulation
• Positive and Negative Affect
• Stress
• Biofeedback

Interventions

BEHAVIORAL

Heart rate variability biofeedback

Participants non-randomized to the single intervention arm will receive a standardized HRV sensor and accompanying smartphone application, along with a 30-45-minute HRVB training session focused on using biofeedback signals to generate a resonant frequency pattern of HRV (coherence) following baseline data collection. Participants will be asked to practice their HRVB skills at home for 10 minutes per day over a 3-week period.

Sponsors & Collaborators

• Arizona State University

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2026-02-01

Completion

2026-02-01

Countries

• United States

Study Locations