Ecological Momentary Music Intervention for the Reduction of Stress

NCT04957966 | Completed

• 1 other identifier: EMMI-T Pilot
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological; Stress, Physiological; Discrimination, Racial

Keywords

Ecological Momentary Intervention; Music; Stress reduction; Discrimination; Cortisol; Alpha-Amylase

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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)

  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)

  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)

  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)

  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

  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

  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

  change from baseline period (week 1) to post period (week 5)

• Change in positive and negative affect

  every evening in the daily diary assessment for 35 days

• Change in fatigue

  every evening in the daily diary assessment for 35 days

• Change in coping behavior

  every evening in the daily diary assessment for 35 days

• Change in avoidance behavior regarding discriminatory events

  every evening in the daily diary assessment for 35 days

Study Arms (1)

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).

Behavioral: self-selected relaxing music

Interventions

self-selected relaxing music BEHAVIORAL

20 minutes music listening

Music listening vs. No music listening

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years
• Sex: female

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vienna: lead

Study Sites (1)

University of Vienna

Vienna, 1010, Austria

Location

MeSH Terms

Conditions

Stress, Psychological; Racism

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Prejudice; Social Behavior; Social Discrimination

Study Officials

• Ricarda Nater-Mewes, Dr. Dr.

  University of Vienna

  PRINCIPAL INVESTIGATOR

• Urs Nater, PhD

  University of Vienna

  PRINCIPAL INVESTIGATOR

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

Model Details: Intra-individually randomized design: Random assignment (50:50) to either the intervention condition or the control condition

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 12, 2021
• Study Start: June 28, 2021
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

AU (1)