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Completed

NCT Number: NCT05832632

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern Denmark. Department of Psychology.

Odense, 5230, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 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 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.

Active Control (Audiobook)

Behavioral

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

Primary outcomes

  1. Perceived Stress Scale (PSS-10)

    Time frame: immediately post intervention

  2. Heart rate variability (HRV)

    Time frame: immediately post intervention

    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).

Secondary outcomes

  1. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: immediately post intervention

  2. Mindful Attention Awareness Scale (MAAS)

    Time frame: immediately post intervention

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Headspace Health

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 27, 2023
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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