Study Stopped
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.
Tailored Ecological Momentary Music Intervention for Stress Reduction
1 other identifier
interventional
39
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2023
CompletedFirst Posted
Study publicly available on registry
April 25, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2025
CompletedAugust 19, 2025
March 1, 2025
2.3 years
April 12, 2023
August 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Subjective Stress Experience
Momentary stress level: visual analogue scales (VAS; 0-100, higher scores indicate a greater level of momentary stress)
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
Change in Short-Term Neuroendocrine Stress: Hypothalamic-Pituitary-Adrenal Axis
Biological Marker: Salivary Cortisol
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
Change in Short-Term Neuroendocrine Stress: Autonomic Nervous System
Salivary Alpha-Amylase
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 (8)
Change in positive and negative affect
from baseline period (week 1) to post period (week 5)
Change in fatigue
from baseline period (week 1) to post period (week 5)
Change in coping behavior
from baseline period (week 1) to post period (week 5)
Change in avoidance behavior regarding discriminatory events
from baseline period (week 1) to post period (week 5)
Change in anticipation of discriminatory events
from baseline period (week 1) to post period (week 5)
- +3 more secondary outcomes
Study Arms (1)
Music listening vs. No music listening
EXPERIMENTALEvery 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).
Interventions
Participants listen to self-selected relaxing music. They can choose between a duration of either 10 minutes or 20 minutes.
Eligibility Criteria
You may qualify if:
- Turkish immigrants (1st or 2nd generation)
- Chronic ethnic discrimination (value of or above 104 on the Everyday Discrimination Scale)
- years
- sex: female
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Vienna
Vienna, Vienna, 1010, Austria
Related Publications (13)
Amirkhan JH. A Factor Analytically Derived Measure of Coping - the Coping Strategy Indicator. J Pers Soc Psychol 1990;59:1066-74.
BACKGROUNDChrousos 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.
PMID: 19488073BACKGROUNDClark 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.
PMID: 16982392BACKGROUNDHarnois 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.
BACKGROUNDKnoll 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.
BACKGROUNDKrohne HW, Egloff B, Kohlmann C-W, Tausch A. Untersuchungen mit einer deutschen Version der
BACKGROUNDLewis 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.
PMID: 25581238BACKGROUNDPascoe EA, Smart Richman L. Perceived discrimination and health: a meta-analytic review. Psychol Bull. 2009 Jul;135(4):531-54. doi: 10.1037/a0016059.
PMID: 19586161BACKGROUNDSchlotz 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.
PMID: 30503527BACKGROUNDSchmitt 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.
PMID: 24547896BACKGROUNDSeaton 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.
PMID: 29777539BACKGROUNDSmets 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.
PMID: 7636775BACKGROUNDHirsch 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.
PMID: 40187786DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricarda Nater-Mewes, Dr. Dr.
University of Vienna
- PRINCIPAL INVESTIGATOR
Urs Nater, Prof.
University of Vienna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 12, 2023
First Posted
April 25, 2023
Study Start
May 1, 2023
Primary Completion
August 12, 2025
Study Completion
August 12, 2025
Last Updated
August 19, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share
Data will be shared upon reasonable request.