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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-08

Study Completion Date

2023-03-01

Brief Summary

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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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Detailed Description

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Conditions

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Psychological Stress Physiological Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Headspace Basics Program

Group Type EXPERIMENTAL

Headspace Basics Program

Intervention Type 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

Group Type EXPERIMENTAL

Headspace Breathing Exercises

Intervention Type 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

Group Type EXPERIMENTAL

Headspace Stress Program

Intervention Type 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)

Group Type ACTIVE_COMPARATOR

Active Control (Audiobook)

Intervention Type BEHAVIORAL

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

Passive Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Headspace Basics Program

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.

Intervention Type BEHAVIORAL

Headspace Breathing Exercises

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.

Intervention Type BEHAVIORAL

Headspace Stress Program

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.

Intervention Type BEHAVIORAL

Active Control (Audiobook)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No