Stress, PsychologicalNCT04957966
Ecological Momentary Music Intervention for the Reduction of Stress
A study testing self-selected relaxing music in people with Stress, Psychological and Stress, Physiological, run by University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Stress, Physiological, Discrimination, Racial
- What is being tested?
- self-selected relaxing music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 28 Jun 2021to 24 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Drug use in the past year, cannabis use in the past 14 days
- Pregnancy
- Breastfeeding
- Impaired hearing or absolute pitch
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Ecological Momentary Music Intervention for the Reduction of Stress in the Daily Life of Turkish Immigrant Women
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.
Read the 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.
- Being tested
- self-selected relaxing music
- Keywords
- Ecological Momentary Intervention, Music, Stress reduction, Discrimination, Cortisol, Alpha-Amylase
- Medical subject headings
- Stress, Psychological, Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-selected relaxing musicBehavioural
20 minutes music listening
| Study group | Role | What they receive |
|---|---|---|
| Music listening vs. No music listening | Experimental | 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). Receives: Behavioral: self-selected relaxing music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 5 weeks
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
Measured: after 5 weeks
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)
Measured: after 5 weeks
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)
Measured: after 5 weeks
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)
Measured: Across the 5-week study period
Change in Subjective Stress Experience
Momentary stress level: visual analogue scales (VAS; 0-100, higher scores indicate a greater level of momentary stress)
Measured: 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
Change in Short-Term Neuroendocrine Stress: Hypothalamic-Pituitary-Adrenal Axis
Biological Marker: Salivary Cortisol
Measured: 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
Change in Short-Term Neuroendocrine Stress: Autonomic Nervous System
Biological Marker: Salivary Alpha-Amylase
Measured: 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 (6)
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)
Measured: change from baseline period (week 1) to post period (week 5)
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)
Measured: every evening in the daily diary assessment for 35 days
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)
Measured: every evening in the daily diary assessment for 35 days
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)
Measured: every evening in the daily diary assessment for 35 days
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)
Measured: every evening in the daily diary assessment for 35 days
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)
Measured: every evening in the daily diary assessment for 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start28 Jun 2021
- Primary completion24 Jan 2023
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intra-individually randomized design: Random assignment (50:50) to either the intervention condition or the control condition
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urs Nater, University of Vienna
- Investigators
- Ricarda Nater-Mewes, Dr. Dr., Principal investigator, University of ViennaUrs Nater, PhD, Principal investigator, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957966
- Sponsor's protocol ID
- EMMI-T Pilot
- Status last verified
- Mar 2023
- First submitted
- 18 Jun 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ecological Momentary Music Intervention for the Reduction of Stress in the Daily Life of Turkish Immigrant Women
- ClinicalTrials.gov ID
- NCT04957966
- Acronym / sponsor ID
- EMMI-T Pilot
- Keywords
- Ecological Momentary Intervention, Music, Stress reduction, Discrimination, Cortisol, Alpha-Amylase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intra-individually randomized design: Random assignment (50:50) to either the intervention condition or the control condition
| Arm | Type | Receives |
|---|---|---|
| Music listening vs. No music listening | Experimental | Behavioral: self-selected relaxing musicRandom 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-selected relaxing music20 minutes music listening | Behavioural | Music listening vs. No music listening |
Primary outcome
Participants' self-reports on the integrability of the study into the daily life
Time frame: after 5 weeks
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
Time frame: after 5 weeks
5 open-ended questions of semi-structured interviews on the perceived effectiveness of the intervention
Perceived burden regarding the intervention
Time frame: after 5 weeks
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
Time frame: after 5 weeks
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
Time frame: Across the 5-week study period
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
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
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
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
Biological Marker: Salivary Cortisol
Change in Short-Term Neuroendocrine Stress: Autonomic Nervous System
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
Biological Marker: Salivary Alpha-Amylase
6 secondary outcomes
Change in participants' behavior regarding music listening
Time frame: change from baseline period (week 1) to post period (week 5)
Change in positive and negative affect
Time frame: every evening in the daily diary assessment for 35 days
Change in fatigue
Time frame: every evening in the daily diary assessment for 35 days
Change in coping behavior
Time frame: every evening in the daily diary assessment for 35 days
Change in avoidance behavior regarding discriminatory events
Time frame: every evening in the daily diary assessment for 35 days
Change in anticipation of discriminatory events
Time frame: every evening in the daily diary assessment for 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricarda Nater-Mewes, Dr. Dr. principal investigator
University of Vienna
Urs Nater, PhD principal investigator
University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-selected relaxing music in people with Stress, Psychological and Stress, Physiological, run by University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' self-reports on the integrability of the study into the daily life (time frame: after 5 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.