Autonomic Nervous System ImbalanceNCT07361731
Evaluating the Feasibility, Acceptability, and Preliminary Outcomes of Heart Rate Variability Biofeedback for Individuals With Opioid Use Disorder.
A study testing Heart rate variability biofeedback in people with Autonomic Nervous System Imbalance and Heart Rate Variability (HRV), run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autonomic Nervous System Imbalance, Heart Rate Variability (HRV), Opioid Use Disorder
- What is being tested?
- Heart rate variability biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
- Conditions
- Autonomic Nervous System Imbalance, Heart Rate Variability (HRV), Opioid Use Disorder, Breathing Techniques, Opioid Craving, Recovery
- Being tested
- Heart rate variability biofeedback
- Keywords
- heart rate variability biofeedback, app based intervention, opioid use disorder, adjunct intervention, opioid cravings, daily diary
- Medical subject headings
- Opioid-Related Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variability biofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HRVB Intervention group | Experimental | Not described Receives: Behavioral: Heart rate variability biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: At the post-intervention assessment (T2), immediately following completion
Secondary outcomes (7)
Perceived Sress
Perceived stress will be measured using the 10-item Perceived Stress Scale (PSS-10), a validated self-report questionnaire that assesses the degree to which individuals perceive their lives as unpredictable, uncontrollable, and overwhelming during the past month. Higher scores indicate greater perceived stress.
Measured: Baseline (T1) and 3 weeks after baseline (T2)
Perceived Affect
Affect will be measured using the Positive and Negative Affect Schedule (PANAS-SF, 20 items), a validated self-report measure that assesses the extent of positive affect (e.g., enthusiasm, alertness) and negative affect (e.g., distress, irritability) experienced over a specified time period. Higher scores indicate greater levels of the respective affective state. In addition, affect will be assessed through a brief daily diary using 12 PANAS-derived items to capture day-to-day fluctuations in positive and negative affect, providing a more nuanced understanding of affect over the 3-week study period.
Measured: Baseline (T1) and 3 weeks after baseline (T2)
Perceived difficulties in emotional regulation
Perceived difficulties in emotional regulation will be measured using the Difficulties in Emotion Regulation Scale-Short Form (DERS-16), which is a validated self-report instrument that assesses global impairments in emotion regulation across multiple domains. It evaluates the frequency with which individuals experience problems such as heightened emotional reactivity, nonacceptance of emotional responses, difficulties maintaining goal-directed behavior when distressed, challenges controlling impulses during negative affect, and limited perceived access to effective emotion regulation strategies. Higher total scores reflect greater overall difficulty in regulating emotions.
Measured: Baseline (T1) and 3 weeks after baseline (T2)
Craving for illicit opioids
Cravings for illicit opioids will be measured using the Obsessive Compulsive Drug Use Scale (OCDUS). This tool will be used to assess craving severity, capturing obsessive thoughts about substance use, compulsive urges, and perceived control over craving-related cognitions and behaviors. Higher scores indicate greater craving intensity and preoccupation with drug use. In addition, craving will be monitored through a brief daily diary item assessing subjective craving severity, allowing examination of day-to-day fluctuations and temporal patterns in craving experiences across the study period.
Measured: Baseline (T1) and 3 weeks after baseline (T2)
Perceived social support
Perceived social support will be measured using The Multidimensional Scale of Perceived Social Support (MSPSS), which is a validated self-report instrument that assesses perceived adequacy of social support from three primary sources: family, friends, and significant others. It evaluates individuals' subjective sense of being valued, understood, and supported emotionally and practically by their social networks. Higher scores indicate greater perceived availability and quality of social support across these domains.
Measured: Baseline (T1) and 3 weeks after baseline (T2)
Self-efficacy to resist substance use
The Drug-Taking Confidence Questionnaire-8 (DTCQ-8) is a brief, validated self-report measure of self-efficacy to resist substance use across high-risk situations. It assesses an individual's perceived confidence in their ability to refrain from using drugs when experiencing common triggers such as negative emotions, social pressure, craving, or interpersonal conflict. Higher scores indicate greater confidence in resisting drug use and a lower likelihood of relapse in these situations.
Measured: Baseline (T1) and 3 weeks after baseline (T2)
Autonomic regulation
Heart rate variability (HRV) metrics, including SDNN, RMSSD, mean heart rate, mean interbeat interval (IBI), total power, LF, HF, and LF/HF ratio, will be used as objective indicators of autonomic nervous system functioning, reflecting overall variability, parasympathetic activity, and sympathetic-parasympathetic balance. In addition, normalized coherence scores from daily HeartMath Inner Balance practice will assess the degree of physiological synchronization and autonomic efficiency. Together, these measures provide complementary indices of autonomic regulation, stress resilience, and emotional regulation capacity, with higher variability and coherence generally indicating healthier autonomic functioning.
Measured: Baseline (T1) and 3 weeks after baseline (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Dec 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System ImbalanceStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunny Wonsun Kim, Ph.D, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361731
- Sponsor's protocol ID
- STUDY00022883
- Status last verified
- May 2026
- First submitted
- 20 Dec 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility, Acceptability, and Preliminary Outcomes of Heart Rate Variability Biofeedback for Individuals With Opioid Use Disorder.
- ClinicalTrials.gov ID
- NCT07361731
- Acronym / sponsor ID
- STUDY00022883
- Conditions
- Autonomic Nervous System Imbalance, Heart Rate Variability (HRV), Opioid Use Disorder, Breathing Techniques, Opioid Craving, Recovery
- Keywords
- heart rate variability biofeedback, app based intervention, opioid use disorder, adjunct intervention, opioid cravings, daily diary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRVB Intervention group | Experimental | Behavioral: Heart rate variability biofeedback |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eligible participants are
Key exclusion criteria (9 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate variability biofeedbackParticipants 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. | Behavioural | HRVB Intervention group |
Primary outcome
Recruitment Rate (Feasibility)
Time frame: From study launch through completion of recruitment
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
Retention Rate (Feasibility)
Time frame: Time Frame: From enrollment through completion of the 3-week intervention
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
HRVB Practice Adherence (Feasibility)
Time frame: From enrollment through completion of the 3-week intervention
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
Daily Diary Compliance (Feasibility)
Time frame: From enrollment through completion of the 3-week intervention
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
Intervention Acceptability Rating (Acceptability)
Time frame: At the post-intervention assessment (T2), immediately following completion of the intervention
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).
Qualitative Acceptability Feedback (Acceptability)
Time frame: At the post-intervention assessment (T2), immediately following completion
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.
7 secondary outcomes
Perceived Sress
Time frame: Baseline (T1) and 3 weeks after baseline (T2)
Perceived Affect
Time frame: Baseline (T1) and 3 weeks after baseline (T2)
Perceived difficulties in emotional regulation
Time frame: Baseline (T1) and 3 weeks after baseline (T2)
Craving for illicit opioids
Time frame: Baseline (T1) and 3 weeks after baseline (T2)
Perceived social support
Time frame: Baseline (T1) and 3 weeks after baseline (T2)
Self-efficacy to resist substance use
Time frame: Baseline (T1) and 3 weeks after baseline (T2)
Autonomic regulation
Time frame: Baseline (T1) and 3 weeks after baseline (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate variability biofeedback in people with Autonomic Nervous System Imbalance and Heart Rate Variability (HRV), run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (Feasibility) (time frame: From study launch through completion of recruitment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.