University of Southern Denmark. Department of Psychology.
Odense, 5230, Denmark
NCT Number: NCT05832632
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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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Odense, 5230, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
30-day smartphone-based Audiobook book consisting of 10 minutes per day.
Time frame: immediately post intervention
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).
Time frame: immediately post intervention
Time frame: immediately post intervention
University of Southern Denmark
Other
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
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