Clinical trial NCT05832632: The Effect of Mindfulness on Psychophysiological Stress in a Population With Elevated Stress Symptoms
Official title: A Randomized Controlled Trial Comparing 3 Formats of Mindfulness Interventions to an Active Control Intervention in a Population With Elevated Levels of Stress: Effects of Subjective and Physiological Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Physiological Stress
Keywords: Stress
Mindfulness
HRV
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Headspace Health
First posted: 2023-04-27
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Stress-related disorders have over the last decade increased and contributed to a worldwide disease burden. At the same time there is limited treatment access for mental health disorders, which has left many people without necessary care. However, in recent years there has been a rise in digital mindfulness interventions. Specifically, these interventions have focused on smartphone-based applications as an effective format for mindfulness training programs. Thus, the goal of this randomized controlled trial is to test the effects of three types of mindfulness programs in a population with elevated stress. The three formats of mindfulness interventions are identical in total training duration but varies in content and intervention length. Specifically, the first intervention consists of programmatic mindfulness content that progress over the course of 30 sessions with a duration of 10 min per session. The second intervention consists of single succinct breathing exercises with no programmatic content over the course of 30 sessions with a duration of 10 min per session. The third intervention consists of mindfulness-based content specifically targeted to people with elevated stress that progress over the course of 20 sessions with a duration of 15 min per session. An active control group listening to an audiobook over the course of 30 sessions with a duration of 10 min per session will be employed and a passive control group.

The study will evaluate outcomes related to subjective stress, sleep quality, mindfulness and physiological effects of stress using HRV.


Eligibility criteria: Inclusion Criteria:

* Moderate to high perceived stress based on PSS total scores (14-40)
* Fluent in English

Exclusion Criteria:

* Regular mindfulness practice for more than 1 month within the last year
* Medical diagnosis e.g. psychiatric/neurological conditions
* Low levels of stress (i.e., less than a score of 14 assessed with the PSS)

Primary outcomes:
measure: Perceived Stress Scale (PSS-10)
timeFrame: immediately post intervention
measure: Heart rate variability (HRV)
timeFrame: immediately post intervention
Secondary outcomes:
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: immediately post intervention
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: immediately post intervention
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark. Department of Psychology.
Study officials:
affiliation: University of Southern Denmark
name: Ulrich Kirk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen, S., & Janicki-Deverts, D. (2012), Who's Stressed? Distributions of Psychological Stress in the United States in Probability Samples from 1983, 2006, and 2009. Journal of Applied Social Psychology, 42: 1320-1334. https://doi.org/10.1111/j.1559-1816.2012.00900.x
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citation: Raio CM, Hartley CA, Orederu TA, Li J, Phelps EA. Stress attenuates the flexible updating of aversive value. Proc Natl Acad Sci U S A. 2017 Oct 17;114(42):11241-11246. doi: 10.1073/pnas.1702565114. Epub 2017 Oct 2.
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