Physiological Stress, Psychological Stress
Conditions
Keywords
Stress, Mindfulness, HRV
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.
Interventions
BEHAVIORALHeadspace 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.
BEHAVIORALHeadspace 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.
BEHAVIORALHeadspace 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.
BEHAVIORALActive Control (Audiobook)
30-day smartphone-based Audiobook book consisting of 10 minutes per day.
Sponsors
Headspace Health
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale (PSS-10) | immediately post intervention | — |
| Heart rate variability (HRV) | 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
| Measure | Time frame |
|---|---|
| The Pittsburgh Sleep Quality Index (PSQI) | immediately post intervention |
| Mindful Attention Awareness Scale (MAAS) | immediately post intervention |
Countries
Denmark
Outcome results
None listed