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临床试验/NCT05829031
NCT05829031终止不适用

Tailored Ecological Momentary Music Intervention to Reduce Stress in the Daily Life of Turkish Immigrant Women

University of Vienna2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
39
试验地点
2
主要终点
Change in Subjective Stress Experience

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Change in Subjective Stress Experience

时间窗: 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

Momentary stress level: visual analogue scales (VAS; 0-100, higher scores indicate a greater level of momentary stress)

Change in Short-Term Neuroendocrine Stress: Autonomic Nervous System

时间窗: 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

Salivary Alpha-Amylase

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

时间窗: 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

Biological Marker: Salivary Cortisol

次要结局

  • 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 anticipation of discriminatory events(from baseline period (week 1) to post period (week 5))
  • Satisfaction with the intervention(after 5 weeks)
  • Change in avoidance behavior regarding discriminatory events(from baseline period (week 1) to post period (week 5))
  • Change in coping behavior(from baseline period (week 1) to post period (week 5))
  • Perceived burden regarding the intervention(after 5 weeks)
  • Usage Rate of the App(after 5 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Urs Nater

Professor

University of Vienna

研究点 (2)

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