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ENROLLING BY INVITATION
NCT07361731
NA

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

Sponsor: Arizona State University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-12-01

Completion Date

2026-05

Last Updated

2026-01-23

Healthy Volunteers

No

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.

Locations (1)

Arizona State University

Phoenix, Arizona, United States