Testing a Music Listening mHealth Intervention for Stress Reduction in Early Recovery (CalmiFy II)

The goal of this study is to 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 12 months of the detoxification from, or reducing, their alcohol use. For this phase, the investigators will conduct a randomized controlled trial of a music-listening intervention that was developed in Phase I of the larger study. The music-listening intervention consists of a personalized Spotify playlist that is deployed when participants are experiencing increased levels of physiological signals of stress, which are detected automatically via a wearable sensor device (Empatica EmbracePlus wristband). This study is a pilot feasibility clinical trial that will be delivered via a micro-randomized trial (MRT) design that randomizes the intervention components in real-time. As a pilot study, primary outcomes include quantitative and qualitative data that measure feasibility and acceptability of the just-in-time intervention.

Participants will be recruited either from regional mental health agencies or from ongoing or completed studies within investigators' college, and will provide data to assess feasibility of the developed mHealth music intervention in individuals in early stages of recovery from alcohol use disorder.

The music listening intervention will be deployed via a micro-randomized process that randomizes the intervention components each time the intervention may be delivered. The participants will be asked to wear the sensor device for 14 days, which will be paired with a music intervention app on a smartphone (hereafter referred to as the "CalmiFy" app). Participants will also be required to listen to music on their smart phone only through the Spotify app, using a Spotify premium account created specifically for the study. When randomized to receive the music listening intervention (a personalized Spotify playlist), participants will report their current context and problem type. Based on these responses, the music recommendation system then suggests music that is tailored to the individual and the specific context. Participants will receive a notification when the intervention (i.e., Spotify playlist) is deployed. They will have the option of accepting it, delaying it for 5 minutes, or cancelling it altogether (i.e., they are not available).

Participants will be surveyed on days in which the music intervention was delivered to assess efficacy of the intervention by asking if the music selection was helpful (or if it actually increased stress) and whether they opt to continue to use the app for the following days. Within 7 days of completion of the 14-day trial, structured qualitative interviews will be scheduled with each participant to better understand their device usage and its efficacy. Guided by the unified theory of acceptance and use of technology (UTUAT), the interview will ask questions about acceptability, barriers and facilitators of using the app in their daily life, the degree to which continuous monitoring affected behavior, and interest in using the app in the future. The interview will include questions to better understand the detected stress events including validity of the automatic detection and context surrounding the event. Participants will also be asked to return the Empatica EmbracePlus sensor device at the time of the interview.

Study Procedures

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 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.

B2. 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. 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. The investigators will exclude individuals who indicate they are experiencing 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 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, installing the CalmiFy app on their smartphone, and phone 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 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").

Lastly, the study coordinator will ask each participant if they would like to schedule the brief music therapy session (conducted online via Zoom) at this time. If so, participants will be provided with a list of available dates and times from which they may confirm the session. Participants will also have the option of scheduling the brief music therapy session at a later time and such individuals will be informed that they will receive an email message within 24 hours that contains information about the sessions and an online link for scheduling. Each participant will be assigned a unique study ID number that will be used to link data from each of the study components to specific individuals.

Brief Music Therapy Session. Within 7 days of the baseline assessment, each participant will meet with a music therapist for a 30-minute training session via Zoom. The therapist will begin the session by assessing the client's stress levels and identifying any physical or emotional symptoms associated with stress. This information will be recorded and used to determine the appropriate music to use during the session. Based on the assessment, the therapist will select 2-3 songs that match the client's emotional and physiological state during the time of the session. After listening to each song with the participant, the therapist will discuss the musical elements of the song and encourage the participant to use the selected songs in their playlist for the next phase of the study. Additionally, in discussion with the participant, the music therapist will identify and note types of music genres or specific songs that may be associated with or triggering of the participant's alcohol use or misuse. Information about the stress and emotional levels of the participant, selected songs for stress regulatio

• Satisfaction with Study [Срок оценки: Within 7 days of study completion.]
• 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.]