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Resonance Breathing Intervention Opioid Use Disorder

Not Applicable
Completed
Conditions
Substance-Related Disorders
Interventions
Other: Resonance Breathing Exercises
Registration Number
NCT05830773
Lead Sponsor
University of Texas at Austin
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
App TrialResonance Breathing ExercisesUse of the smartphone app
Primary Outcome Measures
NameTimeMethod
Average rating of participant satisfaction with the app as assessed by the Acceptability of Intervention Measure8 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.

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

Average rating of participant assessment that the app is appropriate for managing cravings, stress, and anxiety as assessed by the Intervention Appropriateness Measure8 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.

Secondary Outcome Measures
NameTimeMethod
Average rating of participant assessment of their frequency of drug craving as assessed by the Aggregated Drug Craving Scale.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.

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

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

Trial Locations

Locations (1)

Online

🇺🇸

Austin, Texas, United States

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