The Effect of Mindfulness on Psychophysiological Stress in a Population With Elevated Stress Symptoms

NCT05832632 | Completed

• 1 other identifier: 45345
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Stress; Physiological Stress

Keywords

Stress; Mindfulness; HRV

Outcome Measures

Primary Outcomes (2)

• Perceived Stress Scale (PSS-10)

  immediately post intervention

• Heart rate variability (HRV)

  HRV data will be recorded continuously during a rest period, acute stress period\*, and recovery period at both pre and post on a subject-by-subject basis. \*The study will use an acute stress manipulation, specifically the CPT (Cold Pressor Task). The CPT is a standardized physiological acute stressor which has been shown to induce stress, reflected in autonomic stress reactivity (e.g. Lupien et al., 2007; Raio et al., 2017).

  immediately post intervention

Secondary Outcomes (2)

• The Pittsburgh Sleep Quality Index (PSQI)

  immediately post intervention

• Mindful Attention Awareness Scale (MAAS)

  immediately post intervention

Study Arms (5)

Headspace Basics Program

EXPERIMENTAL

Behavioral: Headspace Basics Program

Headspace Breathing Exercises

EXPERIMENTAL

Behavioral: Headspace Breathing Exercises

Headspace Stress Program

EXPERIMENTAL

Behavioral: Headspace Stress Program

Active Control (Audiobook)

ACTIVE COMPARATOR

Behavioral: Active Control (Audiobook)

Passive Control

NO INTERVENTION

Interventions

Headspace Basics Program BEHAVIORAL

30-day smartphone-based mindfulness intervention consisting of 10 minutes per day. The program consist of generic mindfulness techniques such as breath awareness, body scans, mindful noting of thoughts and emotions.

Headspace Basics Program

Headspace Breathing Exercises BEHAVIORAL

30-day smartphone-based breathing exercises. Each exercise consists of box breathing for 1 minute and participants are instructed to complete 10 sessions corresponding to 10 minutes per day.

Headspace Breathing Exercises

Headspace Stress Program BEHAVIORAL

20-day smartphone-based mindfulness intervention consisting of 15 minutes per day. The Stress program content is based on well-established concepts and practices within stress management, and mindfulness, and is targeted to people with elevated stress.

Headspace Stress Program

Active Control (Audiobook) BEHAVIORAL

30-day smartphone-based Audiobook book consisting of 10 minutes per day.

Active Control (Audiobook)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern Denmark: lead
• Headspace Health: collaborator

Study Sites (1)

University of Southern Denmark. Department of Psychology.

Odense, 5230, Denmark

Location

Related Publications (8)

• 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

  BACKGROUND

• Tian F, Shen Q, Hu Y, Ye W, Valdimarsdottir UA, Song H, Fang F. Association of stress-related disorders with subsequent risk of all-cause and cause-specific mortality: A population-based and sibling-controlled cohort study. Lancet Reg Health Eur. 2022 May 28;18:100402. doi: 10.1016/j.lanepe.2022.100402. eCollection 2022 Jul.

  PMID: 35663363 BACKGROUND

• World Health Organization. The impact of COVID-19 on mental, neurological and substance use services: results of rapid assessment. Geneva: World Health Organization; 2020. Available from: https://www.who.int/publications-detail-redirect/978924012455

  BACKGROUND

• Sorkin DH, Janio EA, Eikey EV, Schneider M, Davis K, Schueller SM, Stadnick NA, Zheng K, Neary M, Safani D, Mukamel DB. Rise in Use of Digital Mental Health Tools and Technologies in the United States During the COVID-19 Pandemic: Survey Study. J Med Internet Res. 2021 Apr 16;23(4):e26994. doi: 10.2196/26994.

  PMID: 33822737 BACKGROUND

• Philippe TJ, Sikder N, Jackson A, Koblanski ME, Liow E, Pilarinos A, Vasarhelyi K. Digital Health Interventions for Delivery of Mental Health Care: Systematic and Comprehensive Meta-Review. JMIR Ment Health. 2022 May 12;9(5):e35159. doi: 10.2196/35159.

  PMID: 35551058 BACKGROUND

• 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.

  PMID: 28973957 BACKGROUND

• Lupien SJ, Maheu F, Tu M, Fiocco A, Schramek TE. The effects of stress and stress hormones on human cognition: Implications for the field of brain and cognition. Brain Cogn. 2007 Dec;65(3):209-37. doi: 10.1016/j.bandc.2007.02.007. Epub 2007 Apr 26.

  PMID: 17466428 BACKGROUND

• Kirk U, Staiano W, Hu E, Ngnoumen C, Kunkle S, Shih E, Clausel A, Purvis C, Lee L. App-Based Mindfulness for Attenuation of Subjective and Physiological Stress Reactivity in a Population With Elevated Stress: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Oct 13;11:e47371. doi: 10.2196/47371.

  PMID: 37831493 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Sound Recordings

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Ulrich Kirk, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 27, 2023
• Study Start: November 8, 2021
• Primary Completion: October 4, 2022
• Study Completion: March 1, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)