Tailored Ecological Momentary Music Intervention for Stress Reduction

NCT ID: NCT05829031

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-08-12

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Stress, Psychological Stress, Physiological Discrimination, Racial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intra-individually randomized design: Participants will be randomly assigned (50:50) to either the intervention condition or the control condition
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Targeted music listening

Intervention Type BEHAVIORAL

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

Interventions

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Targeted music listening

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* Insufficient proficiency of the German language
* Body mass index (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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Urs Nater

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricarda Nater-Mewes, Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Vienna

Urs Nater, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Vienna

Locations

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University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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Amirkhan JH. A Factor Analytically Derived Measure of Coping - the Coping Strategy Indicator. J Pers Soc Psychol 1990;59:1066-74.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 19488073 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16982392 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Krohne HW, Egloff B, Kohlmann C-W, Tausch A. Untersuchungen mit einer deutschen Version der

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 25581238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19586161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30503527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24547896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29777539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7636775 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40187786 (View on PubMed)

Related Links

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https://clinicaltrials.gov/ct2/show/NCT04957966?term=EMMI-T&draw=2&rank=1

clinicaltrials.gov registration of the corresponding pilot study

Other Identifiers

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EMMI-T Main

Identifier Type: -

Identifier Source: org_study_id

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