Clinical trial NCT05830773: Resonance Breathing Intervention Opioid Use Disorder
Official title: Resonance Breathing Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Keywords: opioid use disorder
resonance breathing
substance use disorder
heart rate variability
drug craving
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted: 2023-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A convenience sample of participants are chosen for the intervention. There is no waitlist or control condition,
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Average rating of participant satisfaction with the app as assessed by the Acceptability of Intervention Measure
timeFrame: 8 weeks
measure: Average rating of participant assessment that the app is appropriate for managing cravings, stress, and anxiety as assessed by the Intervention Appropriateness Measure
timeFrame: 8 weeks
measure: Average rating of participant assessment of whether the app was easy and practical to use as assessed by the Feasibility of Intervention Measure.
timeFrame: 8 weeks
Secondary outcomes:
measure: Average rating of participant assessment of their frequency of drug craving as assessed by the Aggregated Drug Craving Scale.
timeFrame: 8 weeks
measure: Average rating of participant assessment of their frequency of experieincing stress as assessed by the Peceived Stress Scale.
timeFrame: 8 weeks
measure: Average rating of participant assessment of their frequency of experieincing anxiety as measured by the Beck Anxiety Inventory.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: Online
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Fiona Conway, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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