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

NCT07361731 | Enrolling By Invitation

• 1 other identifier: STUDY00022883
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

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

Keywords

heart rate variability biofeedback; app based intervention; opioid use disorder; adjunct intervention; opioid cravings; daily diary

Outcome Measures

Primary Outcomes (6)

• Recruitment Rate (Feasibility)

  Recruitment feasibility will be assessed as the proportion of eligible individuals who enroll in the HRVB intervention during the recruitment period in the transitional residential treatment setting. Metric: Number of participants enrolled ÷ number of eligible individuals Unit of Measure: Percentage (%) of eligible individuals enrolled Benchmark: ≥ 60% enrollment of eligible individuals

  From study launch through completion of recruitment

• Retention Rate (Feasibility)

  Description: Retention feasibility will be assessed as the proportion of enrolled participants who complete post-intervention (T2) assessments at the end of the 3-week HRVB intervention. Metric: Number of participants completing T2 ÷ number of participants enrolled Unit of Measure: Percentage (%) of enrolled participants completing T2 Benchmark: ≥ 80% completion of post-intervention assessments

  Time Frame: From enrollment through completion of the 3-week intervention

• HRVB Practice Adherence (Feasibility)

  Description: Adherence feasibility will be assessed as the proportion of participants who engage in consistent daily HRVB practice across the intervention period. Self-reported adherence will be corroborated using HeartCloud device data. Metric: Number of participants practicing on ≥70% of intervention days ÷ total number of participants Unit of Measure: Percentage (%) of participants meeting adherence threshold Benchmark: ≥ 70% of participants practice on ≥70% of intervention days

  From enrollment through completion of the 3-week intervention

• Daily Diary Compliance (Feasibility)

  Description: Daily diary compliance will be assessed as the proportion of expected ecological momentary assessment (EMA) diary entries completed during the intervention period. Metric: Number of completed diary entries ÷ number of expected diary entries Unit of Measure: Percentage (%) of expected diary entries completed Benchmark: ≥ 80% of daily diary entries completed

  From enrollment through completion of the 3-week intervention

• Intervention Acceptability Rating (Acceptability)

  Acceptability will be assessed at post-intervention (T2) using a structured 7-item survey evaluating perceived relevance, helpfulness, usability, satisfaction, and likelihood of recommending the intervention. Items are rated on a 5-point Likert scale (1 = strongly disagree/not helpful to 5 = strongly agree/very helpful). Metric: Number of participants rating items as 4 or 5 ÷ total number of respondents Unit of Measure: Percentage (%) of participants endorsing the acceptability threshold Benchmark: ≥ 80% of participants rate the intervention as helpful or very helpful (scores 4-5).

  At the post-intervention assessment (T2), immediately following completion of the intervention

• Qualitative Acceptability Feedback (Acceptability)

  Qualitative acceptability will be assessed using open-ended questions examining perceived benefits, challenges, and recommendations for improvement of the HRVB intervention. Metric: Thematic saturation and frequency of key themes Unit of Measure: Narrative themes categorized as benefits, barriers, and recommendations Benchmark: Identification of actionable themes supporting feasibility and refinement of implementation.

  At the post-intervention assessment (T2), immediately following completion

Secondary Outcomes (7)

• Perceived Sress

  Baseline (T1) and 3 weeks after baseline (T2)

• Perceived Affect

  Baseline (T1) and 3 weeks after baseline (T2)

• Perceived difficulties in emotional regulation

  Baseline (T1) and 3 weeks after baseline (T2)

• Craving for illicit opioids

  Baseline (T1) and 3 weeks after baseline (T2)

• Perceived social support

  Baseline (T1) and 3 weeks after baseline (T2)

Study Arms (1)

HRVB Intervention group

EXPERIMENTAL

Behavioral: Heart rate variability biofeedback

Interventions

Heart rate variability biofeedback BEHAVIORAL

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.

HRVB Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 23, 2026
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-12

Locations

US (1)