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Completed

NCT Number: NCT05830773

Resonance Breathing Intervention Opioid Use Disorder

This study aims to assess the feasibility of an intervention for the management of craving, stress, anxiety, and depression among people who use opioids via a resonance breathing smartphone app.

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Key information

Conditions

Substance-related Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Online

Austin, Texas, 78712, United States

About this study

Most evidence-based treatments for substance use disorders (SUD) require face-to-face interactions with individuals who comprise a recovery support network. However, in the moment relapse occurs, people in recovery are often not in the presence of these trusted individuals. This project aims to address this issue by providing people in recovery with an application (app) that can be added to phones and other mobile devices to help them manage cravings, anxiety, and stress triggers at the specific moments they feel compelled to use. The connection between an individuals mind and body works in both directions. Psychological distress can cause psychosomatic symptoms in the body (e.g., stress is related to multiple chronic health conditions), but individuals can also use their bodies to affect psychology aspects (e.g., exercise can improve mood by releasing endorphins). A similar scientific theory is the foundation of controlled breathing interventions for anxiety, stress, and drug cravings. Psychological distress can disrupt the balance of our Autonomic Nervous System (which is responsible for our fight or flight response to threat), but breathing exercises can restore balance and decrease stress. The goal of this study is to test the feasibility, utility, and efficacy of an app that delivers controlled breathing exercises.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be eligible, participants need to be the legal age of majority (18 years of age or older), have the ability to read and speak in English, and have a history of alcohol or illicit drug use.

Exclusion criteria

Individuals with no access to a smartphone phone with a data plan, inability to provide consent and having suicidal thoughts or psychotic episodes.

Treatment and study plan

Resonance Breathing Exercises

Other

This intervention uses the Camera Heart Rate Variability (CHRV) smartphone application, a resonance breathing app that is available for download to iPhones and Android devices. The CHRV app uses Photoplethysmography (PPG) technology to measure heart rate. PPG is a noninvasive technology that uses a light source (the phone's flashlight) and a photodetector (the phone's camera lens) at the surface of one's skin to measure the volumetric variations of blood circulation. The app also has a timer (to allow the participant to see how long they use the app in each session). The iPhone version of the app also has a breathing pacer (a bar that moves up and down to show the participant when to inhale and exhale). Participants are instructed to initiate a resonance breathing session for at least 5 minutes every day and whenever they experience cravings, feel like they are going to relapse, feel anxious or stressed, or just want to feel calm.

Primary outcomes

  1. Average rating of participant satisfaction with the app as assessed by the Acceptability of Intervention Measure

    Time frame: 8 weeks

    The measure has 4 items on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores are better outcomes. The citation for the measure is Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci 2017; 12(1):108.

  2. Average rating of participant assessment that the app is appropriate for managing cravings, stress, and anxiety as assessed by the Intervention Appropriateness Measure

    Time frame: 8 weeks

    The measure has 4 items on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores are better outcomes. The citation for the measure is Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci 2017; 12(1):108.

  3. Average rating of participant assessment of whether the app was easy and practical to use as assessed by the Feasibility of Intervention Measure.

    Time frame: 8 weeks

    Feasibility entails participant assessment of whether the app was easy and practical to use. The measure has 4 items on a scale from 1 (completely disagree) to 5 (completely agree). Higher scores are better outcomes. The citation for the measure is Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci 2017; 12(1):108.

Secondary outcomes

  1. Average rating of participant assessment of their frequency of drug craving as assessed by the Aggregated Drug Craving Scale.

    Time frame: 8 weeks

    The measure has 5 items on a scale from 0 (Never - 0 times over the past month) to 6 (Nearly all of the time - more than 40 times or more than 6 times per day). Lower scores are better outcomes. The citation for the measure is: Costello MJ, Viel C, Li Y, Oshri A, MacKillop J. Psychometric validation of an adaptation of the Penn Alcohol Craving Scale to assess aggregated drug craving. J Subst Abuse Treat 2020; 119:108127.

  2. Average rating of participant assessment of their frequency of experieincing stress as assessed by the Peceived Stress Scale.

    Time frame: 8 weeks

    The measure has 10 items on a scale from 0 (Never) to 4 (Very Often). Lower scores a better outcomes. The citation for the measure is: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of health and social behavior. 1983 Dec 1:385-96.

  3. Average rating of participant assessment of their frequency of experieincing anxiety as measured by the Beck Anxiety Inventory.

    Time frame: 8 weeks

    The measure has 21 items on a scale from 0 (Not at all) to 4 (Severely). Lower scores are better outcomes. The citation for the measure is: Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol 1988; 56(6):893-7.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Substance Abuse and Mental Health Services Administration (SAMHSA)

Registry information

Official study title

Resonance Breathing Opioid Use Disorder

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2023
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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