Developing a Music Listening mHealth Intervention for Stress Reduction in Early Recovery

NCT07052318 | Recruiting DMC

• 2 other identifiers: 20612R61AA031474
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of this study is to develop and examine the feasibility of a music-listening intervention that can be deployed in "real time" to regulate emotions and reduce momentary stress among young adults within the first 12 months of recovery from alcohol use disorder. We design the study with two phases to address three aims: Phase I includes the first two aims. For Aim 1, we will conduct formative research with a sample of young adults (N = 30) who have are within 12 months of recovery to identify features of music selections that are most effective in reducing momentary stress in real-world, ambulatory settings. For Aim 2, we will focus on developing mobile health technology that uses passive sensing and machine learning to automatically predict moments of heightened stress in real-time and suggest specific musical selections when stress is detected. During Phase II (Aim 3), we will test the feasibility of a novel music-listening intervention among a second unique sample of young adults who are within 12 months of recovery from AUD (N = 30). This protocol refers only to Phase I of the larger study, which focuses on observing music listening preferences and physiological and mental stress among people in early recovery from alcohol use disorder.

Conditions

Alcohol Use Disorder (AUD)

Keywords

recovery; alcohol use disorder; stress; music listening

Outcome Measures

Primary Outcomes (5)

• Electrodermal Activity (EDA)

  EDA will be assessed via a research-level wearable sensor (Empatica EmbracePlus) that will collect continuous physiological data

  14 days

• Heart Rate Variability (HRV)

  HRV will be assessed via a research-level wearable sensor (Empatica EmbracePlus) that will collect continuous physiological data

  14 days

• Music Listening History

  Music listening history will be collected via Spotify by requesting a complete streaming history record for each participant during the study period.

  14 days

• Self-Reported Acute Stress

  Participants will be instructed to press an "event marker" button on the EmbracePlus sensor device during moments that they feel more stressed than usual.

  14 days

• Self-Reported Positive and Negative Emotions

  Participants will report perceptions of positive and negative emotions via the surveys, administered four times each day.

  14 days

Secondary Outcomes (3)

• Satisfaction with Study

  Within 7 days of completing the study.

• Time-line followback (TLFB) measure of alcohol use

  Within 7 days of study completion.

• Recollections of stressful events

  Within 7 days of study completion.

Study Arms (1)

Cohort 1

Main study cohort

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will recruited from behavioral health clinics and the general Spokane, WA community.

You may qualify if:

• Subject can and has signed an Institutional Review Board (IRB) approved informed consent form (ICF).
• Age ≥18 and ≤35 years.
• In early-stage recovery for alcohol use (within 12 months)
• Own a smartphone with a data plan
• Not experiencing symptoms of severe depression
• Not experiencing thoughts of suicide
• Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for alcohol use disorder (AUD)
• Not currently taking medication treatment for opioid use disorder (OUD)
• Able to speak and read English

You may not qualify if:

• Currently experiencing symptoms of severe depression
• Currently experiencing thoughts of suicide
• Currently taking medication treatment for opioid use disorder (OUD)
• Are unable to provide voluntary informed consent.
• Cannot read or speak English.

Sponsors & Collaborators

• Washington State University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Washington State University Research Clinic

Spokane, Washington, 99202, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michae J Cleveland, Ph.D.

  Washington State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Schmidt

CONTACT

509-638-2376; alex.schmidt@wsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Sharable scientific aggregate data generated from this project will be made available as soon as possible, and no later than 3 years past the end of the funding period. The duration of preservation and sharing of the data will be a minimum of 5 years after the funding period.
• Access Criteria: Individuals from the scientific community will be able to access the IPD and supporting information. Data will be discoverable online through standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset

Locations

US (1)