Developing a Music Listening mHealth Intervention for Stress Reduction in Early Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Electrodermal Activity (EDA)
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. 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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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.
结局指标
主要结局
Electrodermal Activity (EDA)
时间窗: 14 days
EDA will be assessed via a research-level wearable sensor (Empatica EmbracePlus) that will collect continuous physiological data
Heart Rate Variability (HRV)
时间窗: 14 days
HRV will be assessed via a research-level wearable sensor (Empatica EmbracePlus) that will collect continuous physiological data
Music Listening History
时间窗: 14 days
Music listening history will be collected via Spotify by requesting a complete streaming history record for each participant during the study period.
Self-Reported Acute Stress
时间窗: 14 days
Participants will be instructed to press an "event marker" button on the EmbracePlus sensor device during moments that they feel more stressed than usual.
Self-Reported Positive and Negative Emotions
时间窗: 14 days
Participants will report perceptions of positive and negative emotions via the surveys, administered four times each day.
次要结局
- 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.)
