ClinicalTrials.gg
TerminatedNCT05829031Updated Aug 19, 2025

Tailored Ecological Momentary Music Intervention for Stress Reduction

An interventional study of Targeted music listening in Stress, Psychological, Stress, Physiological and Discrimination, Racial, sponsored by University of Vienna. Terminated at 1 site in Austria. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-19.

Sponsored by University of Vienna · Not applicable, Interventional, and Treatment

Why this study was terminated
The anticipated study duration was two years. Despite sustained recruitment efforts, the required number of eligible participants could not be enrolled within this timeframe. Therefore, the study was terminated.
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

Ethnic discrimination is associated with mental and physical health impairments. In view of the negative impact of discrimination on health, it is of great importance to investigate interventions to counteract these negative effects.

Based on findings of a pilot study (clinicaltrials.gov identifier: NCT04957966), this study investigates the effectiveness of a tailored ecological momentary music intervention to reduce biological (salivary cortisol, salivary alpha-amylase) and psychological (perceived stress, perceived ethnic discrimination) stress reactions after discriminatory and/or stressful events in the daily life of Turkish immigrant women (N = 50, age range 18-65 years).

An intra-individually randomized design will be used, i.e., participants will be assigned on a random basis either to intervention events (they can choose to listen to music for the duration of 10 or 20 minutes) or to control events (participants are instructed to not listen to music). The whole study period consists of 35 days with a baseline period (week 1), intervention period (week 2-4), and post period (week 5).

Read the detailed description

Ethnic discrimination (ED) represents a complex stressor that triggers psychobiological stress reactions (Pascoe \& Smart Richman, 2009). Experienced chronically, ED can adversely affect mental and physical health (e.g., Lewis et al., 2015; Schmitt et al., 2014), most likely due to dysregulations of psychobiological stress systems (Chrousos, 2009; Schlotz, 2019). In this regard, women may be particularly affected as they face discrimination based on both ethnicity and gender more often compared to men (e.g., Harnois, 2014; Seaton \& Tyson, 2019). Considering the resulting health impairments, it is of great importance to investigate strategies that can mitigate the occurring stress reactions and thereby contribute to health promotion. Therefore, we conducted a pilot study to test the feasibility of an ecological momentary music intervention aiming to reduce stress levels of affected individuals (clinicaltrials.gov identifier: NCT04957966). Based on the findings of the pilot study and power calculations, we will now conduct a larger main study. The primary aim of our study is to examine the effectiveness of an ecological momentary music intervention to reduce psychological and biological (cortisol, alpha-amylase) stress levels after stressful and/or discriminatory events in the daily life of chronically discriminated Turkish immigrant women.

We hypothesize that listening to self-selected, relaxing music after an event of acute stress and/or ethnic discrimination in daily life will result in stronger decreases of psychological (perceived stress, perceived ethnic discrimination) and biological (cortisol, alpha-amylase) stress levels compared to no music listening (immediate effect). Further, we expect a decrease in diurnal psychological and biological stress levels throughout the study period (intermediate effect).

The study consists of three phases: Baseline phase (week 1), intervention phase (week 2 to 4), post intervention phase (week 5).

During the baseline and post intervention phase, we will assess participants' psychological and biological stress fluctuations and perceived ethnic discrimination in daily life. Therefore, participants will be prompted three times a day (11:00 am, 3:00 pm, 7:00 pm) through a study app 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 and/or discriminatory event occurs, participants will be 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 prompt the participants 20 minutes later for an additional data entry (post). As part of every time-contingent and event-contingent report, participants will provide a saliva sample for the analysis of 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.

Every evening before going to bed, participants will complete a daily diary assessment via the study app. In this diary, participants will be asked about their current perceived stress, perceived discrimination, positive and negative affect, fatigue, and coping strategies. Additionally, they will be asked whether discriminatory or stressful events had happened over the course of the day and if so, to describe the event(s). This data entry will not require the collection of a saliva sample.

During the intervention phase (week 2 to 4), the sampling protocol will be the same as in the baseline and post intervention phase (i.e., time-contingent data entries, daily diary assessment, self-initiated event-contingent data entries, post). Additionally, participants will be randomly assigned (50:50) to either the intervention condition (listening to self-selected, relaxing music; participants can choose between the duration of 10 or 20 minutes) or the control condition (no music listening; participants are instructed to continue their pre-data entry activities) after every self-initiated event-contingent report. This intra-individually randomized study design will allow us to compare the effects of music listening vs. no music listening after stressful/discriminatory events on psychological and biological stress levels.

02

Conditions studied

  • Stress, Psychological
  • Stress, Physiological
  • Discrimination, Racial

Keywords

  • Ecological Momentary Intervention
  • Music
  • Stress reduction
  • Discrimination
  • Cortisol
  • Alpha-Amylase
03

In context

Stress, Psychological

844 studies on the registry are indexed under Stress, Psychological; 136 are open to participants now.

This study's enrollment of 39 is below the median of 84 across 688 interventional studies indexed under Stress, Psychological.

Browse Stress, Psychological studies →

Lead sponsor

University of Vienna is the lead sponsor of 49 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Turkish immigrants (1st or 2nd generation)
  • Chronic ethnic discrimination (value of or above 104 on the Everyday Discrimination Scale)
  • 18-65 years
  • sex: female

Exclusion criteria

Exclusion Criteria:

  • Insufficient proficiency of the German language
  • (BMI) above 30 kg/m2
  • Schizophrenia
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Music listening vs. No music listening

    Every participant will be randomly assigned (50:50) to one of the following two conditions: Music listening after a stressful and/or discriminatory event (i.e., intervention condition) or no music listening after a stressful and/or discriminatory event (i.e., control condition).

    Behavioral: Targeted music listening

Interventions

  • BehavioralTargeted music listening

    Participants listen to self-selected relaxing music. They can choose between a duration of either 10 minutes or 20 minutes.

06

What researchers measure

Primary outcomes

  1. Change in Subjective Stress Experience

    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: 20 minutes after T0

  2. Change in Short-Term Neuroendocrine Stress: Hypothalamic-Pituitary-Adrenal Axis

    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: 20 minutes after T0

  3. Change in Short-Term Neuroendocrine Stress: Autonomic Nervous System

    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: 20 minutes after T0

Secondary outcomes

  1. Change in positive and negative affect

    PANAS (Positive Affect Negative Affect Scale; Watson et al., 1988; German version by Krohne et al., 1996) 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: from baseline period (week 1) to post period (week 5)

  2. Change in fatigue

    5 items (one of each scale) of the MFI (Multidimensional Fatigue Inventory; Smets et al., 1995), 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: from baseline period (week 1) to post period (week 5)

  3. Change in coping behavior

    5 items of the Brief-COPE (Coping Orientation to Problems Experienced Inventory; Carver, 1997; German version by Knoll et al., 2005), 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: from baseline period (week 1) to post period (week 5)

  4. 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; Amirkhan, 1990), 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: from baseline period (week 1) to post period (week 5)

  5. Change in anticipation of discriminatory events

    3 items of the Racism-related Vigilance Scale (Clark et al., 2006), 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: from baseline period (week 1) to post period (week 5)

  6. 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)

    Time frame: after 5 weeks

  7. 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)

    Time frame: after 5 weeks

  8. 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)

    Time frame: after 5 weeks

07

Study locations

1 site
  • University of Vienna
    Vienna, State of Vienna 1010, Austria
08

References and documents

Publications

  • Amirkhan JH. A Factor Analytically Derived Measure of Coping - the Coping Strategy Indicator. J Pers Soc Psychol 1990;59:1066-74.
  • Chrousos GP. Stress and disorders of the stress system. Nat Rev Endocrinol. 2009 Jul;5(7):374-81. doi: 10.1038/nrendo.2009.106. Epub 2009 Jun 2. PubMed 19488073 ↗
  • Clark R, Benkert RA, Flack JM. Large arterial elasticity varies as a function of gender and racism-related vigilance in black youth. J Adolesc Health. 2006 Oct;39(4):562-9. doi: 10.1016/j.jadohealth.2006.02.012. Epub 2006 Jul 10. PubMed 16982392 ↗
  • Harnois CE. Are perceptions of discrimination unidimensional, oppositional, or intersectional? Examining the relationship among perceived racial-ethnic-, gender-, and age-based discrimination. Sociol Perspect 2014;57:470-87.
  • Knoll N, Rieckmann N, Schwarzer R. Coping as a mediator between personality and stress outcomes: A longitudinal study with cataract surgery patients. Eur J Pers 2005;19:229-47.
  • Krohne HW, Egloff B, Kohlmann C-W, Tausch A. Untersuchungen mit einer deutschen Version der
  • Lewis TT, Cogburn CD, Williams DR. Self-reported experiences of discrimination and health: scientific advances, ongoing controversies, and emerging issues. Annu Rev Clin Psychol. 2015;11:407-40. doi: 10.1146/annurev-clinpsy-032814-112728. Epub 2015 Jan 2. PubMed 25581238 ↗
  • Pascoe EA, Smart Richman L. Perceived discrimination and health: a meta-analytic review. Psychol Bull. 2009 Jul;135(4):531-54. doi: 10.1037/a0016059. PubMed 19586161 ↗
  • Schlotz W. Investigating associations between momentary stress and cortisol in daily life: What have we learned so far? Psychoneuroendocrinology. 2019 Jul;105:105-116. doi: 10.1016/j.psyneuen.2018.11.038. Epub 2018 Nov 27. PubMed 30503527 ↗
  • Schmitt MT, Branscombe NR, Postmes T, Garcia A. The consequences of perceived discrimination for psychological well-being: a meta-analytic review. Psychol Bull. 2014 Jul;140(4):921-48. doi: 10.1037/a0035754. Epub 2014 Feb 17. PubMed 24547896 ↗
  • Seaton EK, Tyson K. The Intersection of Race and Gender Among Black American Adolescents. Child Dev. 2019 Jan;90(1):62-70. doi: 10.1111/cdev.13093. Epub 2018 May 19. PubMed 29777539 ↗
  • Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o. PubMed 7636775 ↗
  • Hirsch S, Nater UM, Mewes R. Smartphone-based ecological momentary music intervention to reduce stress in Turkish immigrant women: protocol. BMJ Open. 2025 Apr 5;15(4):e090518. doi: 10.1136/bmjopen-2024-090518. PubMed 40187786 ↗

Individual participant data

Plan to share: No — Data will be shared upon reasonable request.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2023 to primary completion in Aug 2025, 27 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 12, 2023
First posted
Apr 25, 2023
StartActual
May 1, 2023
Primary completionActual
Aug 12, 2025
CompletionActual
Aug 12, 2025
Last update
Aug 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05829031
Lead sponsor
University of Vienna
Responsible party
Urs Nater (Professor, University of Vienna) — Principal investigator
First posted
Apr 25, 2023
Start date
May 1, 2023
Primary completion
Aug 12, 2025
Completion
Aug 12, 2025
Last update
Aug 19, 2025

Study contacts

Ricarda Nater-Mewes, Dr. Dr.
principal investigator · University of Vienna
Urs Nater, Prof.
principal investigator · University of Vienna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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