A Randomized Controlled Trial Comparing a 30 Day Mediation App to 30 Day Active Problem Solving App: Stress Management in Customer Service Representatives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Job Stress
研究概览
简要总结
Burnout and stress at work can make individuals less productive, which can carry over into their personal and at-home lives and negatively impact health. Customer service representatives are under especially high strain as they are exposed to significant interpersonal conflict at work, both with frustrated customers and with pressure from coworkers and supervisors. However, recent research has found that different stress management interventions (e.g., mindfulness meditation training) can increase job satisfaction and work productivity. However, individuals with significant stress might find these training program classes difficult to attend with their busy schedules. Newer interventions have focused on smartphone mobile applications as an effective delivery system for these training programs. Thus, the purpose of this project is to conduct a randomized controlled trial (RCT) comparing two different stress management smartphone app programs to evaluate effects on job-related outcomes, functional and structural brain outcomes, and biology.
详细描述
Approach: Employees will be given study flyers describing the study and encouraged to call a project hotline to evaluate their study eligibility. Eligible participants will be scheduled for an in-person study baseline and neuroimaging appointment at Carnegie Mellon University where they will provide written informed consent, complete baseline survey measures, provide several drops of blood via a finger prick (Dried Blood Spot (DBS) samples), and complete a 60-minute neuroimaging scan. After completing baseline measures participants will be instructed on how to download and use the Headspace smartphone app, and will be randomly assigned to one of the two programs. Participants will be asked to complete a 7- minute end-of-day daily diary measure each day during the treatment period, which will measure stress, affect, sleep, and workplace perceptions (a text message link will be sent an hour before the participant's standard bedtime each day). The project team will monitor treatment adherence (participants who do not complete a daily practice session will be called and reminded the following day). In the week following the end of the treatment period, participants will be scheduled to come back to Carnegie Mellon for a post-treatment appointment where they will complete the same measures as at baseline (survey measures, DBS, and neuroimaging). Participants will then be debriefed, compensated, and dismissed. Approximately two months after participants complete the 30-day program, we will call them for a 15-minute follow-up call. During this call, participants will answer a few questionnaire items and a brief program evaluation.
Interventions: Participants will be asked to complete one lesson daily for 30- days on the Headspace app; the first ten lessons will be 10 minutes long, the next ten will be 15 minutes long, and the final ten will be 20 minutes long. The mindfulness program will consist of the standard base program offered in Headspace. The Recharge program will consist of problem solving and stress management instruction.
Setting and Participants: David Creswell's Health and Human Performance Laboratory at Carnegie Mellon University will direct this study. Participants will be customer service employees (those who interact with customers daily via phone or in-person interactions) recruited from the Pittsburgh region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will remain masked to which program the participant will use. However the experimenter will be helping set up the participants with the app content and thus will not be masked to condition.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fluent in English
- •18-70 years old
- •Planning to remain in the Pittsburgh area for the duration of participation
- •Endorse significant work stress
排除标准
- •Any significant mental and physical health conditions
- •Metal implants
- •Significant claustrophobia
研究组 & 干预措施
Headspace
30-day smartphone based mindfulness training intervention consisting of 10-minutes for the first 10 days, 15 minutes for the next 10 days, and 20 minutes for the final 10 days.
干预措施: Mindfulness Training (Behavioral)
Recharge
30-day smartphone based reflection and problem solving training intervention consisting of 10-minutes for the first 10 days, 15 minutes for the next 10 days, and 20 minutes for the final 10 days.
干预措施: Reflection and Problem Solving (Behavioral)
结局指标
主要结局
Job Stress
时间窗: Change in job stress over 30 day period and 90 day post-intervention follow-up
Evaluated using Job Content Questionnaire. The Job Content Questionnaire is designed to measure the social and psychological characteristics of the workplace environment such as psychological demands, decision latitude, social support, physical demands, and job insecurity. The Job Stress measure will be calculated by combining the Psychological Demands and Decision Latitude subscales. The Psychological Demands subscale is 5-items and the Decision Latitude is 9-items. All are scored on a 1-4 Likert, resulting in a range of 14-56, scored such that higher numbers indicate greater job stress. Analyses will focus on a time (baseline, post-intervention, follow-up) by group interaction, and subsequent within group and within timepoint main effects. Here we hypothesize that while there will be a main effect of time, there will be a significant time by group interaction on reducing job stress.
Functional neural activity to Negative Stimuli
时间窗: Change in functional neural activity over 30 day period.
Functional neural activity to a task displaying negative vs. neutral images. Analyses will focus on a time (baseline, post-intervention) by group (Headspace, Recharge) interaction, and subsequent within group and within timepoint main effects. ROI and connectivity analyses will focus on the threat/salience network. Correlations with changes in included questionnaires and biology will also be assessed.
Changes in Amygdala Volume
时间窗: Change in amygdala volume over 30 day period.
Structural changes in the amygdala will also be assessed using time by group interaction and time and group main effects. Voxel based morphometry techniques will be used. In particular, change in gray matter volume will also be correlated with our relevant outcomes to assess whether changes in structure are associated with important changes in behavior, biology or affect.
Work Life Conflict
时间窗: Change in work-life conflict over 30 day period.
Evaluated using Work Life Conflict Scale.The Work Life Conflict designed to measure conflict between work and non-work experiences. The 5-item measure has been used in previous work, and participants respond to each item using a 1-7 Likert scale with higher numbers indicating greater work-life conflict. Some previous work has averaged responses to the 5-items, thus resulting in a range of 1-7 for this scale. Analyses will focus on a time by group interaction, and subsequent within group and within timepoint main effects. Here we hypothesize that while there will be a main effect of time, there will be a significant time by group interaction on reducing work-life conflict.
Life Work Conflict
时间窗: Change in life-work conflict over 30 day period.
Evaluated using Life Work Conflict Scales.The Life Work Conflict designed to measure conflict between non-work experiences and the individual's experiences at work. The 5-item measure has been used in previous work, and participants respond to each item using a 1-7 Likert scale with higher numbers indicating greater life-work conflict. Some previous work has averaged responses to the 5-items, thus resulting in a range of 1-7 for this scale. Analyses will focus on a time by group interaction, and subsequent within group and within timepoint main effects. Here we hypothesize that while there will be a main effect of time, there will be a significant time by group interaction on reducing life-work conflict.
Burnout
时间窗: Change in burnout over 30 day period and 90 day post-intervention follow-up
Evaluated using a burnout scale for customer service representatives. This scale is used to measures feelings of burnout, a psychological disposition characterized by emotional exhaustion, lack of personal accomplishment, and a tendency to depersonalize others. The 24-item scale uses a 6-point Likert scale, and items are summed to create a composite score, with a range of 24-144, higher scores indicating greater burnout. Analyses will focus on a time (baseline, post-intervention, follow-up) by group interaction, and subsequent within group and within timepoint main effects. Here we hypothesize that while there will be a main effect of time, there will be a significant time by group interaction on reducing burnout.
Job Satisfaction
时间窗: Change in job satisfaction over 30 day period.
Evaluated using Job Satisfaction Questionnaire. This is a 10-item scale, each item scored on a 1-5 Likert scale, resulting in a range of 10-50, with higher scores indicating greater job satisfaction as follows: * 10-26: very low satisfaction * 27-31: low satisfaction * 32-38: average satisfaction * 39-41: high satisfaction * 42-50: very high satisfaction Analyses will focus on a time (baseline, post-intervention, follow-up) by group interaction, and subsequent within group and within timepoint main effects. Here we hypothesize that while there will be a main effect of time, there will be a significant time by group interaction on increasing job satisfaction.
Functional neural activity to Positive Stimuli
时间窗: Change in functional neural activity over 30 day period.
Functional neural activity to a task displaying positive vs. neutral images. Analyses will focus on a time (baseline, post-intervention) by group (Headspace, Recharge) interaction, and subsequent within group and within timepoint main effects. ROI and connectivity analyses will focus on the reward network. Correlations with changes in included questionnaires and biology will also be assessed.
Diffusion Spectrum Imaging (DSI): Assess change in brain white matter tracts
时间窗: Change in white matter integrity over 30 day period.
Diffusion spectrum analyses will include time x group changes in white matter using fractional anisotropy (FA). Analyses will focus on whole brain FA (i.e., white matter integrity across the whole brain). Further analyses will explore associations between changes in white matter and our other outcomes of interest (behavior, biology, affect, functional task performance, etc.).
Changes in Reward Network Volume
时间窗: Change in brain volume over 30 day period.
Structural changes in the reward network will also be assessed using time by group interaction and time and group main effects. Voxel based morphometry techniques will be used. In particular, these changes in gray matter volume will also be correlated with our relevant outcomes to assess whether changes in structure are associated with important changes in behavior, biology or affect.
Number of Sick Days taken
时间窗: 2-month post-intervention follow-up
Evaluated by asking at 2-month post-intervention follow-up. Analyses will focus on a main effect of group on lower number of sick days taken.
Resting state functional connectivity
时间窗: Change in resting state functional connectivity over 30 day period.
Resting state functional connectivity will also be assessed using a time by group interaction and time and group main effects. We will conduct analyses focusing on the default mode and frontostriatal networks. Correlations with changes in included questionnaires and biology will also be assessed.
Inflammatory Gene Expression
时间窗: Change in gene expression over 30 day period.
Changes in gene expression will be assessed using a time by group interaction (with time and group main effects also examined as ancillary findings, and in the event a significant time by group interaction is observed, follow-up group-stratified "simple effects" analyses of time effects may also be conducted to help interpret results). Analyses will focus an a priori-specified gene regulation pattern involving increased expression of inflammation-related genes and decreased expression of antiviral gene - a pattern called the conserved transcriptional response to adversity (CTRA).
Daily Diary--Change in perceived stress at work
时间窗: Assessed daily to assess change in perceived stress during 30 day intervention
Measures will be assessed end-of-day using three items from Perceived Stress Scale adapted for work. Answered on a 0-never to 4-very often scale, with higher scores indicating greater perceived stress at work. Analyses will use multilevel modeling to explore differences between groups. We hypothesize a main effect of time, and a possible time by group interaction effect on perceived stress.
Daily Diary--Change in self-reported productivity at work
时间窗: Assessed daily to assess change in self-reported productivity during 30 day intervention
Measures will be assessed end-of-day ("I was productive at work today." on 1-7 agreement Likert scale). Analyses will use multilevel modeling to explore differences between groups. Here, we will explore a possible time by group interaction on increased productivity.
Daily Diary--Change in self-reported engagement in meaningful activities at work
时间窗: Assessed daily to assess change in engagement of meaningful activities during 30 day intervention
Measures will be assessed end-of-day ("I feel like I did something meaningful at work today." on 1-7 agreement Likert scale). Analyses will use multilevel modeling to explore differences between groups. Here, we will explore a possible time by group interaction on increased self-reports of meaningful activities at work.
Daily Diary--Change in self-reported attention at work
时间窗: Assessed daily to assess change in self-reported attention at work during 30 day intervention
Measures will be assessed end-of-day ("At work today, I found myself doing things without really paying attention." adapted from Mindful Attention and Awareness Scale, answered on 1-6 frequency scale). Analyses will use multilevel modeling to explore differences between groups. Here, we will explore a possible time by group interaction on increased attention at work.
Daily Diary--Interpersonal conflict with customers and coworkers
时间窗: Assessed daily to assess change in interpersonal conflict during 30 day intervention
Interpersonal conflict with customers and coworkers will be assessed by the following questions (1-"none at all" to 5-"a great deal" scale): * How much conflict did you experience with customers today? * How much conflict with coworkers and managers/supervisors did you experience today? These items were selected to capture the listed outcome measure and do not come from a previously used scale. The outcome measure will be assessed end-of-day during the 30 day period. Analyses will use multilevel modeling to explore differences between groups. Here, we will explore a possible time by group interaction on reduced interpersonal conflict with customers and coworkers.
次要结局
- Perceived Stress(Change in perceived stress over 30 day period.)
- Self-reported physical health(Change in self-reported physical over 30 day period.)
- Self-reported depressive symptoms(Change in self-reported depressive symptoms over 30 day period.)
- Loneliness(Change in self-reported loneliness over 30 day period.)
- C-reactive protein (CRP) levels(Change in C-Reactive Protein levels over 30 day period.)
- Mindfulness(Change in mindfulness over 30 day period.)
- Social Support Perceptions(Change in social support perceptions over 30 day period.)
- Distress Tolerance/Acceptance(Change distress tolerance/acceptance over 30 day period.)
- Equanimity(Change in equanimity over 30 day period.)