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

Participants for this study will be recruited either from regional mental health agencies or from ongoing or completed WSU College of Medicine studies.

Study Procedures are as follows. Online pre-screening. Interested potential participants will first be directed to a secure online screening questionnaire that assesses basic inclusion criteria (age between 18 - 35 years, early-stage recovery, and own a smartphone with a data plan. The pre-screening survey will be administered via REDCap. The pre-screening survey will also include preferred contact information, including mobile phone, text, and email address. Interested individuals who pass the initial screening, will be contacted by study staff in order to schedule an in-person visit where the subject will be asked a series of more detailed screening questions to determine their eligibility for the study. Those who do not meet the pre-screening criteria will be informed that they are not eligible for the study.

Informed consent and In-person screening. Those who endorse the pre-screening criteria will take part in an in-person study entry interview where they will provide written informed consent and complete additional measures assessing eligibility. The interview will be conducted by a trained research coordinator and will take place in a private room located in private offices reserved for WSU faculty in either Spokane, WA or Pullman, WA. Informed consent will be assembled in writing for each participant to read and take home if they wish. Research coordinators will walk through the informed consent packet with the individual before they begin participation. The consent form will be signed electronically via REDCap, and the participant may take the paper copy home with them.

Prior to initiating the informed consent process, potential participants will also be asked to provide breath samples to determine their blood alcohol content (BAC). Participants whose BAC level is greater than 0.00, but less than 0.05, will be asked to either remain in the clinic until breath results indicate otherwise, or given the option of rescheduling their visit. Participants whose BAC results indicate impairment (\> 0.05) will be given the option of either waiting in the clinic until BAC \< 0.5 or, alternately, research staff will offer to schedule a ride-share company (e.g. Uber) to drive them to their home.

After reviewing the informed consent document with each participant, the research staff will administer the in-person screening survey. This survey will include the following components: 1) the Patient Health Questionnaire (PHQ-9); 2) the Ask Suicide-Screening Questions (ASQ) tool; and 3) the Alcohol Symptom Checklist (ASC).

The nine-item version of the Patient Health Questionnaire (PHQ-9), will be administered to ensure the absence of depressive symptoms. We will exclude individuals who indicate they are experiencing at least severe depressive symptoms, operationalized by a score of 20 or higher on the PHQ-9.

In addition to the PHQ-9, determination of imminent risk of suicide risk among potential subjects will be assessed using the Ask Suicide-Screening Questions (ASQ) tool developed by the National Institute of Mental Health (NIMH). The ASQ tool is a set of four brief suicide screening questions that takes less than 5 minutes to administer. If a subject answers "No" to the four questions, screening is complete for that subject and no intervention is necessary. If a subject answers "Yes" to any of the four questions, or refuses to answer, they will be considered a positive screen and an additional assessment will be administered to determine potential risk vs. imminent risk. If imminent risk is identified the clinical staff will be alerted immediately and the subject will be kept in sight. If potential risk is identified, the clinic staff will be notified and will administer a brief suicide safety assessment.

The 11-item Alcohol Symptom Checklist is a self-report questionnaire that asks patients whether they have experienced each of the 11 Alcohol Use Disorder (AUD) criteria within the past year. Each of the 11 items on the Alcohol Symptom Checklist maps onto one the 11 criteria for AUD as currently defined by the Diagnostic and statistical manual of mental disorders, 5th edition, published by the American Psychiatric Association. Patients indicate whether each AUD criterion was present or absent within the past year and Alcohol Symptom Checklist scores reflect AUD criteria counts that range from 0-11. Endorsing 2-3 criteria, 4-5 criteria, or 6-11 criteria is consistent with DSM-5 definitions for mild, moderate, or severe AUD, respectively. Participants who endorse at least 2 criteria will be eligible for the study.

Baseline Survey and Orientation Session. Participants who meet full eligibility criteria will be directed immediately to the online baseline survey, which will be completed on a laptop computer in the private clinic office using REDCap software. The survey is estimated to take 20 minutes to complete. After completing the baseline survey, the participants will be provided with a detailed explanation of the study procedures for each study component, focusing on instructions for wearing the sensor device and EMA survey components. Training for the wearable wristband will include information about how to wear and remove the wristband, and how to care for the wristband.

The participants will also receive instructions about answering the online surveys and using the Spotify app during the orientation session. For participants with an existing Spotify account, this training will emphasize switching to the research Spotify account, rather than their personal account during the study period. As part of this process, participants with an existing Spotify account will be asked to transfer up to 5 of their Spotify playlists from their personal Spotify accounts to the research study Spotify account. To accomplish this, participants will follow these steps: 1) open their personal Spotify account; 2) open the desired playlist; 3) right-click on the playlist and select 'Invite Collaborators'; 4) share the link with the research study Spotify account; 5) log into the research study Spotify account and use the shared link to access the playlist; 6) save the playlist by creating a new personal copy that is not collaborative. The study coordinator will then assist the participant create a new playlist that is composed of the five songs indicated in the baseline survey (Survey item: "Please list below five (5) songs that you would use to calm down in a stressful situation").

For participants who do not have a personal Spotify account, the training will focus first on downloading the Spotify app to their mobile phone, followed by general instructions about using the Spotify app. The study coordinator will then assist the participant create a new playlist that is composed of the five songs indicated in the baseline survey (Survey item: "Please list below five (5) songs that you would use to calm down in a stressful situation").

Ambulatory Session. Following the orientation session, the participants will be asked to wear the sensor device during waking hours for fourteen consecutive days to provide continuous monitoring of physiological stress. Participants will also be asked to listen to music on their smart phone only through the Spotify app, using a Spotify premium account created specifically for the research study, to allow music listening history data to be collected. To identify moments of heightened stress, participants will be instructed to press an "event marker" button on the sensor device at any time they feel "more stressed, overwhelmed, or anxious than usual." The event marker will be time-stamped.

Ecological Momentary Assessment. Our current data collection infrastructure, includes a front-end app (called CalmiFy) along with back-end server and databases for collecting self-reported EMA data. A brief EMA-based survey will be administered through the CalmiFy app interface to collect participants' self-reported perceptions of acute stress, negative and positive emotions, and alcohol-related cravings. To capture these dynamic processes, the EMA survey will be administered four times per day between 9am and 9pm across the 14 days, consistent with our previous research. If there is no response to the initial prompt, the respondent will be reminded at 5-minute intervals up to three times. After the 3rd reminder, the EMA survey will become inaccessible (i.e., expires). To reduce participant burden, each EMA survey is expected to require only 3-5 minutes to complete.

Brief Check-In. Approximately 7 days after beginning the ambulatory session, the participants will be asked to attend a brief check-in session via Zoom. This session is expected to take between 15-30 minutes and will provide an opportunity to confirm that all study components are satisfactory and problem-solve any issues that need to be addressed. The check-in session will also include administration of a timeline-follow back (TLFB) measure of recent alcohol use. In this procedure, participants will first be presented with a chart of the U.S. Standard Drink definition and then asked to indicate the number of drinks consumed on each calendar day across the 7-day assessment period. A calendar method will also be used to review participants' recollections of stressful events that have occurred and to provide additional context for the machine learning algorithms, such as false positive and negative rates.

Structured Qualitative Interview. Within 7 days of conclusion of the 14-day ambulatory session, participants will participate in a structured qualitative debriefing interview that will last about 20-30 minutes and will be audio-recorded for transcription. The interview will be structured to assess significant events that occurred during the study protocol and will be informed by the EMA and physiological data that may suggest particularly difficult or stressful days and/or parts of days. Participants will also respond to questions asking about any problems that may have occurred during the study (including if any songs increased their stress), interference of the study with daily-life routines, and overall satisfaction with the study procedures. The interview session will also include administration of a timeline-follow back (TLFB) measure of recent alcohol use. In this procedure, participants will first be presented with a chart of the U.S. Standard Drink definition and then asked to indicate the number of drinks consumed on each calendar day across the days since their brief check-in session. A calendar method will also be used to review participants' recollections of stressful events that occurred since the brief check-in and to provide additional context for the machine learning algorithms, such as false positive and negative rates. Participants will also be asked to return the Empatica EmbracePlus sensor device at the time of the interview.

Statistical Methods

Data collected in this study will comprise three types: 1) physiological data obtained from continuous monitoring via the EmbracePlus wearable device; 2) self-reported quantitative data obtained from baseline surveys and music intervention responses; and 3) qualitative data obtained from structured interviews at the conclusion of the pilot feasibility study. To account for missing data in the quantitative components, we will use full information maximum likelihood estimation (FIML) approaches,4 which have been shown to result in unbiased parameter estimates under many missing data situations in the context of longitudinal data, including under some violations of assumptions, which will also be assessed using Little's MCAR test.

Self-Reported Data. Prior to main analyses, we will conduct preliminary data screening of the self-reported quantitative data. Descriptive statistics and preliminary Pearson c

• Satisfaction with Study [Срок оценки: Within 7 days of completing the study.]
• Time-line followback (TLFB) measure of alcohol use [Срок оценки: Within 7 days of study completion.]
• Recollections of stressful events [Срок оценки: Within 7 days of study completion.]