Testing a Music Listening mHealth Intervention for Stress Reduction in Early Recovery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Skin Conductance Response (SCR) Rate
研究概览
简要总结
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. The investigators design the study with two phases to address three aims: Phase I includes the first two aims. For Aim 1, the investigators will conduct formative research with a sample of young adults who have are within 12 months of recovery (N = 30) to identify features of music selections that are most effective in reducing momentary stress in real-world, ambulatory settings. For Aim 2, the investigtors 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), the investigators 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 II of the larger study.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Stress Feedback
This arm includes only the stress feedback component. The stress feedback draws on a skills-based model of emotion regulation that emphasizes the ability to identify and label emotions, followed by either actively modifying negative emotions or accepting negative emotions when necessary. Participants will receive a prompt to identify their current emotion, followed by questions regarding their current context.
干预措施: Stress Feedback (Behavioral)
Music Listening + Stress Feedback
This arm includes both the stress feedback component and the music listening component. The music listening component is an adaptive playlist that is updated as changes in the user's stress level are detected. To provide personalized music recommendations, we use a supervised learning approach to design an algorithm, referred to as music feature prediction, which predicts optimal values of music features (e.g., energy, valence, instrumentalness, acousticness) that are hypothesized to result in reducing stress. These feature values, referred to as effective music features, are then used to generate a personalized music playlist.
干预措施: Stress Feedback (Behavioral)
Music Listening + Stress Feedback
This arm includes both the stress feedback component and the music listening component. The music listening component is an adaptive playlist that is updated as changes in the user's stress level are detected. To provide personalized music recommendations, we use a supervised learning approach to design an algorithm, referred to as music feature prediction, which predicts optimal values of music features (e.g., energy, valence, instrumentalness, acousticness) that are hypothesized to result in reducing stress. These feature values, referred to as effective music features, are then used to generate a personalized music playlist.
干预措施: Music Listening (Behavioral)
结局指标
主要结局
Skin Conductance Response (SCR) Rate
时间窗: Assessed during the 14-day ambulatory assessment phase
Reported as SCRs/minute and refers to duration-weighted rate of SCR across all clean segments of the electrodermal activity (EDA) data collected via the EmbracePlus wearable device.
Skin Conductance Response (SCR) Amplitude
时间窗: Assessed during the 14-day ambulatory assessment phase
Calculated from the period of the beginning / onset of the SCR to the peak value within the SCR (μS / μmho) across all clean segments of the electrodermal activity (EDA) data collected via the EmbracePlus wearable device. It is essentially a delta function from SCR onset to the SCR peak as determined by the change in the tonic EDA.
Skin Conductance Response (SCR) Rise Time
时间窗: Assessed during the 14-day ambulatory assessment phase
Reported as number of seconds (secs) and refers to the time taken from SCR onset to reach peak amplitude within the SCR across all clean segments of the electrodermal activity (EDA) data collected via the EmbracePlus wearable device.
Skin Conductance Response (SCR) Decay Time
时间窗: Assessed during the 14-day ambulatory assessment phase
Time (microseconds) taken by the SCR to drop from the apex to the minimum of the peak SCR across all clean segments of the electodermal activity (EDA) data collected via the EmbracePlus wearable device.
Skin Conductance Response (SCR) Width
时间窗: Assessed during the 14-day ambulatory assessment phase
The width of the SCR peak from onset to recovery duration measured in seconds (secs). Encompasses both rise and decay phases across all clean segments of the electrodermal activity (EDA) data collected via the EmbracePlus wearable device.
Skin Conductance Response (SCR) Area Under the Curve (AUC)
时间窗: Assessed during the 14-day ambulatory assessment phase
The baseline-corrected area under the phasic curve per SCR measured as µS·s across all clean segments of the electrodermal activity (EDA) data collected via the EmbracePlus wearable device.
MeanNN
时间窗: Assessed during the 14-day ambulatory assessment phase
A time-domain feature of the HRV data that refers to the mean RR interval. measured in milliseconds (ms) collected via the EmbracePlus wearable device.
SDNN
时间窗: Assessed during the 14-day ambulatory assessment phase
A time-domain feature of the HRV data that refers to the standard deviation of all the NN intervals for each 5 minute segment of a 24 hour HRV recording. measured in milliseconds (ms) collected via the EmbracePlus wearable device.
RMSSD
时间窗: Assessed during the 14-day ambulatory assessment phase
A time-domain feature of the HRV data that refers to the root mean square of successive RR interval differences. measured in milliseconds (ms) collected via the EmbracePlus wearable device.
pNN50
时间窗: Assessed during the 14-day ambulatory assessment phase
A time-domain feature of the HRV data that refers to the percentage of successive RR intervals that differ by more than 50 milliseconds. measured as a percentage (%); collected via the EmbracePlus wearable device.
pNN20
时间窗: Assessed during the 14-day ambulatory assessment phase
A time-domain feature of the HRV data that refers to the percentage of successive RR intervals that differ by more than 20 milliseconds. measured as a percentage (%); collected via the EmbracePlus wearable device.
CVNN
时间窗: Assessed during the 14-day ambulatory assessment phase
A time-domain feature of the HRV data that refers to the ratio of the SDNN/MeanNN to represent normalized HRV; collected via the EmbracePlus wearable device
SD1
时间窗: Assessed during the 14-day ambulatory assessment phase
A nonlinear Poincaré measure of short-term HRV that measures short-term HRV in milliseconds (ms) and correlates with baroreflex sensitivity (BRS), which is the change in IBI duration per unit change in BP, and HF power. The RMSSD is identical to the non- linear metric SD1, which reflects short-term HRV. SD1 predicts diastolic BP, HR Max - HR Min, RMSSD, pNN50, SDNN, and power in the Low Frequency (LF) and High Frequency (HF) bands, and total power during 5 minute recordings. Collected via the EmbracePlus wearable device.
SD2
时间窗: Assessed during the 14-day ambulatory assessment phase
A nonlinear Poincaré measure of long-term HRV that measures the standard deviation of each point from the y = x + average R-R interval. The SD2 provides a measure of short- and long-term HRV in milliseconds (ms) and correlates with Low Frequency (LF) power. Collected via the EmbracePlus wearable device.
SD1/SD2
时间窗: Assessed during the 14-day ambulatory assessment phase
A nonlinear Poincaré measure that captures the ratio of short- to long-term HRV and is calculated as the ratio of SD1/SD2. SD1/SD2 measures the unpredictability of the RR time series and and is correlated with the LF/HF ratio. Collected via the EmbracePlus wearable device.
Music Listening History
时间窗: Assessed during the 14-day ambulatory assessment phase
Music listening history will be collected via Spotify by requesting a complete streaming history record for each participant during the study period.
次要结局
- Satisfaction with Study(Within 7 days of study completion.)
- Time-line followback (TLFB) measure of alcohol use(Within 7 days of study completion.)
- Recollections of stressful events(Within 7 days of study completion.)