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

University of Southern Denmark (SDU)

Status: Completed

Conditions: Psychological Stress; Physiological Stress

Treatments: Behavioral: Headspace Stress Program; Behavioral: Headspace Breathing Exercises; Behavioral: Active Control (Audiobook); Behavioral: Headspace Basics Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05832632

45345

Details and patient eligibility

About

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.

Enrollment: 225 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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225 participants in 5 patient groups

Headspace Basics Program

Experimental group

Treatment:

Behavioral: Headspace Basics Program

Headspace Breathing Exercises

Experimental group

Treatment:

Behavioral: Headspace Breathing Exercises

Headspace Stress Program

Experimental group

Treatment:

Behavioral: Headspace Stress Program

Active Control (Audiobook)

Active Comparator group

Treatment:

Behavioral: Active Control (Audiobook)

Passive Control

No Intervention group