Resonance Breathing Intervention Opioid Use Disorder

NCT05830773 | Completed

• 1 other identifier: STUDY00000590
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance-Related Disorders

Keywords

opioid use disorder; resonance breathing; substance use disorder; heart rate variability; drug craving

Outcome Measures

Primary Outcomes (3)

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

  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.

  8 weeks

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

  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.

  8 weeks

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

  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.

  8 weeks

Secondary Outcomes (3)

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

  8 weeks

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

  8 weeks

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

  8 weeks

Study Arms (1)

App Trial

EXPERIMENTAL

Use of the smartphone app

Other: Resonance Breathing Exercises

Interventions

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.

App Trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator

Study Sites (1)

Online

Austin, Texas, 78712, United States

Location

Related Publications (10)

• Vafaie N, Kober H. Association of Drug Cues and Craving With Drug Use and Relapse: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2022 Jul 1;79(7):641-650. doi: 10.1001/jamapsychiatry.2022.1240.

  PMID: 35648415 BACKGROUND

• Kennedy AP, Epstein DH, Jobes ML, Agage D, Tyburski M, Phillips KA, Ali AA, Bari R, Hossain SM, Hovsepian K, Rahman MM, Ertin E, Kumar S, Preston KL. Continuous in-the-field measurement of heart rate: Correlates of drug use, craving, stress, and mood in polydrug users. Drug Alcohol Depend. 2015 Jun 1;151:159-66. doi: 10.1016/j.drugalcdep.2015.03.024. Epub 2015 Apr 7.

  PMID: 25920802 BACKGROUND

• Price JL, Bates ME, Morgano J, Todaro S, Uhouse SG, Vaschillo E, Vaschillo B, Pawlak A, Buckman JF. Effects of arousal modulation via resonance breathing on craving and affect in women with substance use disorder. Addict Behav. 2022 Apr;127:107207. doi: 10.1016/j.addbeh.2021.107207. Epub 2021 Dec 17.

  PMID: 34953433 BACKGROUND

• Brzozowski A, White RG, Mitchell IJ, Beech AR, Gillespie SM. A feasibility trial of an instructed breathing course in prison to improve emotion regulation in people with substance use difficulties. The Journal of Forensic Psychiatry & Psychology 2020; 32(2):308-25.

  BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.

  PMID: 3204199 BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

• 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 Dec;119:108127. doi: 10.1016/j.jsat.2020.108127. Epub 2020 Sep 16.

  PMID: 33138922 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Conway FN, Kane H, Dorsainvil M, Kennedy P, Cance JD. Mobile resonance frequency breathing smartphone application to support recovery among people with opioid use disorder: Study protocol for feasibility study. PLoS One. 2024 Jan 31;19(1):e0296278. doi: 10.1371/journal.pone.0296278. eCollection 2024.

  PMID: 38295049 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Study Officials

• Fiona Conway, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: A convenience sample of participants are chosen for the intervention. There is no waitlist or control condition,

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 26, 2023
• Study Start: March 9, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)