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

Study Overview
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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.

Official Title
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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

Conditions
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Psychological Stress, Physiological Stress

Intervention / Treatment
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* Behavioral: Headspace Basics Program
* Behavioral: Headspace Breathing Exercises
* Behavioral: Headspace Stress Program
* Behavioral: Active Control (Audiobook)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fluent in English Moderate to high perceived stress based on PSS total scores (14-40) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Headspace Basics Program<br> | Behavioral: Headspace Basics Program<br>* 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.<br>|
| Experimental: Headspace Breathing Exercises<br> | Behavioral: Headspace Breathing Exercises<br>* 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.<br>|
| Experimental: Headspace Stress Program<br> | Behavioral: Headspace Stress Program<br>* 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.<br>|
| Active Comparator: Active Control (Audiobook)<br> | Behavioral: Active Control (Audiobook)<br>* 30-day smartphone-based Audiobook book consisting of 10 minutes per day.<br>|
| No Intervention: Passive Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pittsburgh Sleep Quality Index (PSQI) |  | immediately post intervention | 
| Mindful Attention Awareness Scale (MAAS) |  | immediately post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Mindfulness, HRV