Open and Calm – A randomized controlled trial evaluating a public stress reduction program in Denmark
Christian Jensen, Jon Lansner, Anders Petersen, Signe Vangkilde, Signe Pertou Ringkøbing, Vibe G. Frøkjær, Dea Adamsen, Gitte M. Knudsen, John W. Denninger, Steen Gregers Hasselbalch
BMC Public Health December 1, 2015 DOI: 10.1186/s12889-015-2588-2 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 72 |
| Population | Adults who complained to their general practitioner about reduced daily functioning due to prolonged stress or who responded to an online health survey on stress |
| Duration | 9-week intervention, 3-month follow-up |
| Keywords | Biostatistics Stress reduction Public health Randomized controlled trial Reduction mathematics Environmental health Physical therapy Surgery Nursing |
| Citations | 53 |
| Registration | NCT02140307 |
| Key findings | The OC program produced significantly larger improvements than treatment as usual on all outcomes, including perceived stress, depressive symptoms, quality of life, sleep disturbances, and mental health, with effects sustained at 3 months. |
Abstract
Background: Prolonged psychological stress is a risk factor for illness and constitutes an increasing public health challenge creating a need to develop public interventions specifically targeting stress and promoting mental health. The present randomized controlled trial evaluated health effects of a novel program: Relaxation-Response-based Mental Health Promotion (RR-MHP).
Methods: The multimodal, meditation-based course was publicly entitled "Open and Calm" (OC) because it consistently trained relaxed and receptive ("Open") attention, and consciously non-intervening ("Calm") witnessing, in two standardized formats (individual or group) over nine weeks. Seventy-two participants who complained to their general practitioner about reduced daily functioning due to prolonged stress or who responded to an online health survey on stress were randomly assigned to OC formats or treatment as usual, involving e.g., unstandardized consultations with their general practitioner. Outcomes included perceived stress, depressive symptoms, quality of life, sleep disturbances, mental health, salivary cortisol, and visual perception. Control variables comprised a genetic stress-resiliency factor (serotonergic transporter genotype; 5-HTTLPR), demographics, personality, self-reported inattentiveness, and course format.
Results: Intent-to-treat analyses showed significantly larger improvements in OC than in controls on all outcomes. Treatment effects on self-reported outcomes were sustained after 3 months and were not related to age, gender, education, or course format. The dropout rate was only 6 %.
Conclusions: The standardized OC program reduced stress and improved mental health for a period of 3 months. Further testing of the OC program for public mental health promotion and reduction of stress-related illnesses is therefore warranted. A larger implementation is in progress.
Trial Registration: ClinicalTrials.gov.: NCT02140307. Registered May 14 2014.