Ecological Momentary Music Intervention for the Reduction of Stress
Primary Purpose
Stress, Psychological, Stress, Physiological, Discrimination, Racial
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
self-selected relaxing music
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychological focused on measuring Ecological Momentary Intervention, Music, Stress reduction, Discrimination, Cortisol, Alpha-Amylase
Eligibility Criteria
Inclusion Criteria:
- Turkish immigrants (1st or 2nd generation)
- Weekly ethnic discrimination (at least 2 discriminatory events per week; value of or above 104 on the Everyday Discrimination Scale)
- 18-65 years
- Sex: female
Exclusion Criteria:
- Insufficient proficiency of the German language
- Body mass index (BMI) above 30 kg/m2
- Mental disorders (i.e., current major depressive episode, lifetime psychosis or bipolar disorder, borderline personality disorder, eating disorder in the past 5 years, substance-induced disorder in the past 2 years)
- Chronic somatic diseases
- Medical conditions or medications known to affect endocrine or autonomic functioning
- Abuse of alcohol in the past 6 months
- Drug use in the past year, cannabis use in the past 14 days
- Pregnancy
- Breastfeeding
- Impaired hearing or absolute pitch
Sites / Locations
- University of Vienna
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Music listening vs. No music listening
Arm Description
Random assignment (50:50) of every participant to one of the following two conditions: Music listening after a stressful/discriminatory event (i.e., intervention condition) or no music listening after a stressful/discriminatory event (i.e., control condition).
Outcomes
Primary Outcome Measures
Participants' self-reports on the integrability of the study into the daily life
6 open-ended questions of semi-structured interviews on the integrability of the study into the daily life of the participants
Participants' self-reports on the perceived effectiveness of the intervention
5 open-ended questions of semi-structured interviews on the perceived effectiveness of the intervention
Perceived burden regarding the intervention
10 items of a self-developed questionnaire on perceived burden regarding the intervention (5-point Likert Scales, higher scores indicate greater levels of perceived burden)
Satisfaction with the intervention
Combination of the following 10 items to measure participants' satisfaction with the intervention:
6 items of a self-developed questionnaire on satisfaction with the intervention (5-point Likert Scales, higher scores indicate greater levels of satisfaction)
adaption of 4 items of a self-developed satisfaction questionnaire (Loo Gee, 2018; 5-point Likert Scales, higher scores indicated greater levels of satisfaction)
Usage Rate of the App
Timestamped log-data of the app to determine usage rate by the participants (higher usage rate indicates a greater feasibility of the intervention)
Change in Subjective Stress Experience
Momentary stress level: visual analogue scales (VAS; 0-100, higher scores indicate a greater level of momentary stress)
Change in Short-Term Neuroendocrine Stress: Hypothalamic-Pituitary-Adrenal Axis
Biological Marker: Salivary Cortisol
Change in Short-Term Neuroendocrine Stress: Autonomic Nervous System
Biological Marker: Salivary Alpha-Amylase
Secondary Outcome Measures
Change in participants' behavior regarding music listening
Occurrence of music listening after a stressful/discriminatory event (greater occurrence of music-listening indicates a better outcome)
Change in positive and negative affect
PANAS (Positive Affect Negative Affect Scale) is a self-report questionnaire that consists of two scales to measure positive affect and negative affect, each scale consists of 10 items (5-point Likert Scales, for every scale higher scores indicate greater positive/negative affect)
Change in fatigue
5 items (one of each scale) of the MFI (Multidimensional Fatigue Inventory), a self-report questionnaire consisting of 20 items that are assigned to 5 scales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation (5-point Likert Scales, higher scores on each subscale indicate greater levels of each subscale-specific type of fatigue)
Change in coping behavior
5 items of the Brief-COPE (Coping Orientation to Problems Experienced), a self-report questionnaire that consists of 28 items to measure effective and ineffective ways of coping with stressful life events; one item of each subscale: active coping, use of emotional support, use of instrumental support, venting, religion; 5-point Likert-Scales with higher scores for each subscale indicating a greater level of the subscale-specific coping behavior)
Change in avoidance behavior regarding discriminatory events
Combination of the following 4 items to measure change in avoidance behavior:
3 items of the avoidance subscale of the CSI (Coping Strategy Indicator), a self-report questionnaire of situational coping that consists of 33 items with the subscales avoidance, problem solving, and seeking social support (5-point Likert-Scales with higher scores indicating greater levels of avoidance behavior)
one self-developed item to measure avoidance behavior, in particular the item measures if the person avoided situations and/or persons for fear of being discriminated against (5-point Likert-Scales with higher scores indicating greater levels of avoidance behavior)
Change in anticipation of discriminatory events
3 items of the Racism-related Vigilance Scale, a 6-item scale to measure heightened vigilance regarding discriminatory events (5-point Likert-Scales with higher scores indicating greater levels of anticipation of discriminatory events)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04957966
Brief Title
Ecological Momentary Music Intervention for the Reduction of Stress
Official Title
An Ecological Momentary Music Intervention for the Reduction of Stress in the Daily Life of Turkish Immigrant Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
January 24, 2023 (Actual)
Study Completion Date
January 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ethnic discrimination is a prevalent problem in the European Union and other regions. In view of the significant negative impacts of discrimination on mental and physical health, it is of high relevance to counteract these negative effects and provide appropriate interventions. This study aims to investigate the feasibility and the effectiveness of a mobile-based intervention, delivering self-selected relaxing music to buffer biological (salivary cortisol, salivary alpha-amylase) and psychological (perceived stress, perceived ethnic discrimination) stress reactions in moments of acute stress and perceived ethnic discrimination in the everyday life of Turkish immigrant women (N=20, age range 18-65 years). An intra-individually randomized design will be used, i.e., participants will be instructed on a random basis to either listen to music (intervention event) or not (control event). The whole study period consists of 35 days with a baseline period (week 1), intervention period (week 2-4), and post period (week 5). To investigate the feasibility of the intervention, post-monitoring interviews will be conducted after the end of the whole study period.
Detailed Description
The experience of unfair treatment because of one's own ethnicity, i.e., ethnic discrimination, constitutes a complex stressor which triggers both physical and psychological stress reactions. In this regard, women may constitute a particularly vulnerable group, as they may be confronted with intersectional stigmata, i.e., both ethnicity-related and gender-related stigmata. Considering the resulting health impairments many people with migration background are confronted with, it is of great importance to provide interventions with the potential to minimize those negative consequences. Recognizing this necessity, an ecological momentary music intervention was developed in order to reduce psychological and biological (cortisol, alpha-amylase) stress levels due to perceived ethnic discrimination in everyday life. The primary aim of this study is to investigate the feasibility and the effectiveness of this mobile-based intervention.
It is hypothesized that listening to music after an event of acute stress and/or ethnic discrimination will result in stronger decreases in psychological (perceived stress, perceived ethnic discrimination), and biological (cortisol, alpha-amylase) stress levels compared to no music listening in everyday life (immediate effect). Further, it is expected that a decrease in diurnal psychological and biological stress levels will be observed throughout the study period (intermediate effect) and that participants will start to consume or increase their deliberate consumption of music after an event of acute stress and/or ethnic discrimination in their everyday life after the intervention (behavior change). In addition, it is hypothesized that the feasibility of the intervention will be confirmed by participants' self-reports of high usefulness of and satisfaction with the intervention as well as by a high usage rate.
The study design is as follows: Baseline period (week 1), intervention period (week 2 to 4), post period (week 5).
During the baseline and post period, psychological and biological stress fluctuations and perceived ethnic discrimination in daily life will be assessed. To this end, participants will be signaled three times a day (9:00 am, 2:00 pm, 7:00 pm) in order to answer questions on their momentary levels of stress, perceived discrimination, positive and negative affect, and their music-listening activities (time-contingent data entries). Additionally, whenever a stressful or discriminatory event occurs, participants are instructed to initiate a data entry by themselves in order to report their momentary levels of stress, perceived discrimination, positive and negative affect, and to answer questions on the current situation. To investigate activities after such self-initiated, event-contingent data entries, the app will signal the participants 20 (post 1) and 35 minutes (post 2) later for an additional data entry. As part of every time-contingent and event-contingent report, participants will provide a saliva sample in order to examine biological stress markers: salivary cortisol levels as index of hypothalamic-pituitary-adrenal axis (HPA axis) activity, salivary alpha-amylase as index of autonomic nervous system (ANS) activity.
A daily diary assessment will be conducted every evening at the same time. In this diary, participants will be asked about their current perceived stress, perceived discrimination, positive and negative affect, fatigue, coping strategies. Additionally, they will be asked whether discriminatory events had happened over the course of the day and if so, to describe the event(s). For this data entry, no saliva sample will be collected.
During the Intervention period (week 2 to 4), the sampling protocol will be the same as in baseline and post period (i.e., time-contingent data entries, daily diary assessment, self-initiated event-contingent data entries, post 1, post 2). Additionally, after every self-initiated event-contingent report, participants will be randomly assigned (50:50) to either the intervention event (listening to music for 20 minutes) or the control event (no music listening, continue the activity before the data entry). This approach constitutes an intra-individually randomized design.
To investigate the feasibility of the intervention, qualitative data from post-monitoring interviews will be gathered at the end of the study period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Stress, Physiological, Discrimination, Racial
Keywords
Ecological Momentary Intervention, Music, Stress reduction, Discrimination, Cortisol, Alpha-Amylase
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intra-individually randomized design: Random assignment (50:50) to either the intervention condition or the control condition
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music listening vs. No music listening
Arm Type
Experimental
Arm Description
Random assignment (50:50) of every participant to one of the following two conditions: Music listening after a stressful/discriminatory event (i.e., intervention condition) or no music listening after a stressful/discriminatory event (i.e., control condition).
Intervention Type
Behavioral
Intervention Name(s)
self-selected relaxing music
Intervention Description
20 minutes music listening
Primary Outcome Measure Information:
Title
Participants' self-reports on the integrability of the study into the daily life
Description
6 open-ended questions of semi-structured interviews on the integrability of the study into the daily life of the participants
Time Frame
after 5 weeks
Title
Participants' self-reports on the perceived effectiveness of the intervention
Description
5 open-ended questions of semi-structured interviews on the perceived effectiveness of the intervention
Time Frame
after 5 weeks
Title
Perceived burden regarding the intervention
Description
10 items of a self-developed questionnaire on perceived burden regarding the intervention (5-point Likert Scales, higher scores indicate greater levels of perceived burden)
Time Frame
after 5 weeks
Title
Satisfaction with the intervention
Description
Combination of the following 10 items to measure participants' satisfaction with the intervention:
6 items of a self-developed questionnaire on satisfaction with the intervention (5-point Likert Scales, higher scores indicate greater levels of satisfaction)
adaption of 4 items of a self-developed satisfaction questionnaire (Loo Gee, 2018; 5-point Likert Scales, higher scores indicated greater levels of satisfaction)
Time Frame
after 5 weeks
Title
Usage Rate of the App
Description
Timestamped log-data of the app to determine usage rate by the participants (higher usage rate indicates a greater feasibility of the intervention)
Time Frame
Across the 5-week study period
Title
Change in Subjective Stress Experience
Description
Momentary stress level: visual analogue scales (VAS; 0-100, higher scores indicate a greater level of momentary stress)
Time Frame
from baseline period (week 1) to post period (week 5); during the course of the intervention: T0: directly after a stressful/discriminatory event, T1: after 20 minutes music listening/ not music listening; T2: 15 minutes after T1
Title
Change in Short-Term Neuroendocrine Stress: Hypothalamic-Pituitary-Adrenal Axis
Description
Biological Marker: Salivary Cortisol
Time Frame
from baseline period (week 1) to post period (week 5); during the course of the intervention: T0: directly after a stressful/discriminatory event, T1: after 20 minutes music listening/ not music listening; T2: 15 minutes after T1
Title
Change in Short-Term Neuroendocrine Stress: Autonomic Nervous System
Description
Biological Marker: Salivary Alpha-Amylase
Time Frame
from baseline period (week 1) to post period (week 5); during the course of the intervention: T0: directly after a stressful/discriminatory event, T1: after 20 minutes music listening/ not music listening; T2: 15 minutes after T1
Secondary Outcome Measure Information:
Title
Change in participants' behavior regarding music listening
Description
Occurrence of music listening after a stressful/discriminatory event (greater occurrence of music-listening indicates a better outcome)
Time Frame
change from baseline period (week 1) to post period (week 5)
Title
Change in positive and negative affect
Description
PANAS (Positive Affect Negative Affect Scale) is a self-report questionnaire that consists of two scales to measure positive affect and negative affect, each scale consists of 10 items (5-point Likert Scales, for every scale higher scores indicate greater positive/negative affect)
Time Frame
every evening in the daily diary assessment for 35 days
Title
Change in fatigue
Description
5 items (one of each scale) of the MFI (Multidimensional Fatigue Inventory), a self-report questionnaire consisting of 20 items that are assigned to 5 scales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation (5-point Likert Scales, higher scores on each subscale indicate greater levels of each subscale-specific type of fatigue)
Time Frame
every evening in the daily diary assessment for 35 days
Title
Change in coping behavior
Description
5 items of the Brief-COPE (Coping Orientation to Problems Experienced), a self-report questionnaire that consists of 28 items to measure effective and ineffective ways of coping with stressful life events; one item of each subscale: active coping, use of emotional support, use of instrumental support, venting, religion; 5-point Likert-Scales with higher scores for each subscale indicating a greater level of the subscale-specific coping behavior)
Time Frame
every evening in the daily diary assessment for 35 days
Title
Change in avoidance behavior regarding discriminatory events
Description
Combination of the following 4 items to measure change in avoidance behavior:
3 items of the avoidance subscale of the CSI (Coping Strategy Indicator), a self-report questionnaire of situational coping that consists of 33 items with the subscales avoidance, problem solving, and seeking social support (5-point Likert-Scales with higher scores indicating greater levels of avoidance behavior)
one self-developed item to measure avoidance behavior, in particular the item measures if the person avoided situations and/or persons for fear of being discriminated against (5-point Likert-Scales with higher scores indicating greater levels of avoidance behavior)
Time Frame
every evening in the daily diary assessment for 35 days
Title
Change in anticipation of discriminatory events
Description
3 items of the Racism-related Vigilance Scale, a 6-item scale to measure heightened vigilance regarding discriminatory events (5-point Likert-Scales with higher scores indicating greater levels of anticipation of discriminatory events)
Time Frame
every evening in the daily diary assessment for 35 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Turkish immigrants (1st or 2nd generation)
Weekly ethnic discrimination (at least 2 discriminatory events per week; value of or above 104 on the Everyday Discrimination Scale)
18-65 years
Sex: female
Exclusion Criteria:
Insufficient proficiency of the German language
Body mass index (BMI) above 30 kg/m2
Mental disorders (i.e., current major depressive episode, lifetime psychosis or bipolar disorder, borderline personality disorder, eating disorder in the past 5 years, substance-induced disorder in the past 2 years)
Chronic somatic diseases
Medical conditions or medications known to affect endocrine or autonomic functioning
Abuse of alcohol in the past 6 months
Drug use in the past year, cannabis use in the past 14 days
Pregnancy
Breastfeeding
Impaired hearing or absolute pitch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricarda Nater-Mewes, Dr. Dr.
Organizational Affiliation
University of Vienna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Urs Nater, PhD
Organizational Affiliation
University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vienna
City
Vienna
ZIP/Postal Code
1010
Country
Austria
12. IPD Sharing Statement
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Ecological Momentary Music Intervention for the Reduction of Stress
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