Clinical trial NCT04957966: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Stress, Physiological
Discrimination, Racial
Keywords: Ecological Momentary Intervention
Music
Stress reduction
Discrimination
Cortisol
Alpha-Amylase
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intra-individually randomized design: Random assignment (50:50) to either the intervention condition or the control condition
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Participants' self-reports on the integrability of the study into the daily life
timeFrame: after 5 weeks
measure: Participants' self-reports on the perceived effectiveness of the intervention
timeFrame: after 5 weeks
measure: Perceived burden regarding the intervention
timeFrame: after 5 weeks
measure: Satisfaction with the intervention
timeFrame: after 5 weeks
measure: Usage Rate of the App
timeFrame: Across the 5-week study period
measure: Change in Subjective Stress Experience
timeFrame: 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
measure: Change in Short-Term Neuroendocrine Stress: Hypothalamic-Pituitary-Adrenal Axis
timeFrame: 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
measure: Change in Short-Term Neuroendocrine Stress: Autonomic Nervous System
timeFrame: 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 outcomes:
measure: Change in participants' behavior regarding music listening
timeFrame: change from baseline period (week 1) to post period (week 5)
measure: Change in positive and negative affect
timeFrame: every evening in the daily diary assessment for 35 days
measure: Change in fatigue
timeFrame: every evening in the daily diary assessment for 35 days
measure: Change in coping behavior
timeFrame: every evening in the daily diary assessment for 35 days
measure: Change in avoidance behavior regarding discriminatory events
timeFrame: every evening in the daily diary assessment for 35 days
measure: Change in anticipation of discriminatory events
timeFrame: every evening in the daily diary assessment for 35 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
affiliation: University of Vienna
name: Ricarda Nater-Mewes, Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vienna
name: Urs Nater, PhD
role: PRINCIPAL_INVESTIGATOR
References: