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Resonance Breathing Intervention Opioid Use Disorder

Primary Purpose

Substance-Related Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resonance Breathing Exercises
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Substance-Related Disorders focused on measuring opioid use disorder, resonance breathing, substance use disorder, heart rate variability, drug craving

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • OnlineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

App Trial

Arm Description

Use of the smartphone app

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Average rating of participant assessment of their frequency of drug craving as assessed by the Aggregated Drug Craving Scale.
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.
Average rating of participant assessment of their frequency of experieincing stress as assessed by the Peceived Stress Scale.
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.
Average rating of participant assessment of their frequency of experieincing anxiety as measured by the Beck Anxiety Inventory.
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.

Full Information

First Posted
March 30, 2023
Last Updated
April 13, 2023
Sponsor
University of Texas at Austin
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA)
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1. Study Identification

Unique Protocol Identification Number
NCT05830773
Brief Title
Resonance Breathing Intervention Opioid Use Disorder
Official Title
Resonance Breathing Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
Keywords
opioid use disorder, resonance breathing, substance use disorder, heart rate variability, drug craving

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A convenience sample of participants are chosen for the intervention. There is no waitlist or control condition,
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
App Trial
Arm Type
Experimental
Arm Description
Use of the smartphone app
Intervention Type
Other
Intervention Name(s)
Resonance Breathing Exercises
Intervention Description
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 Outcome Measure Information:
Title
Average rating of participant satisfaction with the app as assessed by the Acceptability of Intervention Measure
Description
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.
Time Frame
8 weeks
Title
Average rating of participant assessment that the app is appropriate for managing cravings, stress, and anxiety as assessed by the Intervention Appropriateness Measure
Description
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.
Time Frame
8 weeks
Title
Average rating of participant assessment of whether the app was easy and practical to use as assessed by the Feasibility of Intervention Measure.
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Average rating of participant assessment of their frequency of drug craving as assessed by the Aggregated Drug Craving Scale.
Description
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.
Time Frame
8 weeks
Title
Average rating of participant assessment of their frequency of experieincing stress as assessed by the Peceived Stress Scale.
Description
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.
Time Frame
8 weeks
Title
Average rating of participant assessment of their frequency of experieincing anxiety as measured by the Beck Anxiety Inventory.
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fiona Conway, PhD
Phone
832-630-1372
Email
fiona.conway@utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fiona Conway, PhD
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Online
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona Conway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data (IPD) will be shared
Citations:
PubMed Identifier
35648415
Citation
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.
Results Reference
background
PubMed Identifier
25920802
Citation
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.
Results Reference
background
PubMed Identifier
34953433
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
28851459
Citation
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.
Results Reference
background
PubMed Identifier
3204199
Citation
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.
Results Reference
background
PubMed Identifier
20957426
Citation
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.
Results Reference
background
PubMed Identifier
33138922
Citation
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.
Results Reference
background
PubMed Identifier
6668417
Citation
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.
Results Reference
background

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Resonance Breathing Intervention Opioid Use Disorder

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