Relaxation-Response-based Mental Health Promotion - Open and Calm 2013

Study Overview
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Brief Summary
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The purpose of the study is to investigate health-promoting and stress-reducing psychological, physiological and hormonal effects of a 9-week meditation-based course in personal health and to examine potential baseline factors for any such effects. Thus, the investigators will investigate the course format (individual course or group-based course) as a potential factor the course outcome, and also individual background factors such as demographics and genetic variations.

Official Title
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Study of Potential Health Effects of a Relaxation-response-based Mental Health Promotion Course (RR-MHP) and the Possibilities for Its Applications in the Danish Public Health Sector

Conditions
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Stress Psychological, Stress Physiological, Quality of Life

Intervention / Treatment
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* Behavioral: Relaxation Response-based Mental Health Promotion (RR-MHP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Experience of stress, defined as a Cohen's perceived stress scale score > 12. Speaks and reads Danish fluently. Ability to use the internet to complete questionnaires. Participation in face-to-face study information meeting. Signed agreement to the study conditions and informed consent form Exclusion Criteria Other current treatment (psychological, medical or other) for stress, depression, anxiety, phobias, traumas or other psychological problems. Other current treatment for bodily illnesses, such as pain, migraine, cancer. More than one diagnose with psychiatric disease (e.g. anxiety, depression) within the past 3 years. Body-Mass Index > 30. Major Depression Inventory score > 25 at inclusion interview. Physical handicaps affecting life stress or quality of life chronically. Drug use (> 50 times hash during the past two years; max 20 times harder drugs, max 2 times per month since the 18th birthday on average; no periods > 3 years where the use of drugs exceeded two times per month). Alcohol use > 21 drinks/week for men, and > 14 drinks/week for women and AUDIT-scores (a scale of alcohol-related problems) >20. Serious head trauma.

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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation training, group format<br>The course Relaxation Response-based Mental Health Promotion (publicly referred to as Open and Calm) is given in group format. The intervention entails 9 courses (1 per week of 2.5 hrs), a course book (120 pages), audio support (6 guided meditative practices), access to a webpage with additional information, and the possibility of two personal sessions with the intervention instructor (a certified psychologist). | Behavioral: Relaxation Response-based Mental Health Promotion (RR-MHP)<br>* The Open and Calm intervention is based on a standardized 9-week program. Week 1 uses a simple mantra-based meditation. Week 2 and 5 uses focus on the body. Week 3 and 6 uses focus on thoughts and emotions. Week 4 and 7 uses focus on social relationships. Weeks 8 and 9 were entitled The focus you feel like, where participants chose their own focus (e.g. two weeks of bodily focus if that was most relevant for a person, while another might chose 1 week focusing on emotions and another focusing on a social relationship).<br>* Other names: 3RP;|
| Active Comparator: Meditation training, individual format<br>The course Relaxation Response-based Mental Health Promotion (Open and Calm) is given by the same instructor as for group formats using precisely the same material and methods, but in about 6-9 (as to each persons' individual needs and preferences) face-to-face meetings. | Behavioral: Relaxation Response-based Mental Health Promotion (RR-MHP)<br>* The Open and Calm intervention is based on a standardized 9-week program. Week 1 uses a simple mantra-based meditation. Week 2 and 5 uses focus on the body. Week 3 and 6 uses focus on thoughts and emotions. Week 4 and 7 uses focus on social relationships. Weeks 8 and 9 were entitled The focus you feel like, where participants chose their own focus (e.g. two weeks of bodily focus if that was most relevant for a person, while another might chose 1 week focusing on emotions and another focusing on a social relationship).<br>* Other names: 3RP;|
| No Intervention: Wait-list control<br>This arm is an inactive wait-list control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores on Perceived Stress on Cohen's Perceived Stress Scale | The investigators expect a decrease in perceived stress of significantly larger magnitude in interventional groups than in waitlist controls across the three time points | From baseline to post-treatment (9 weeks later) and to 3-month follow-up | 
| Cortisol secretion as measured by the cortisol awakening response | The investigators expect a significant reduction of cortisol secretion in intervention groups and larger than in wait-list controls. Specifically, the investigators analyze the Area Under Curve with respect to Ground (total cortisol output) after awakening. Cortisol was only collected for 2/3 data waves (N = 48) due to logistics. COMMENT: The investigators have two primary outcomes, but both are measures of stress levels. The investigators expect to see both hormonal and perceived stress improvements. | From baseline to post-treatment (after 9 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pittsburgh Sleep Quality Index (PSQI) | The investigators expect a larger improvement of sleep quality in the intervention groups than in the wait-list controls over the course of the three time points | From baseline to post-treatment (9 weeks later) and to 3-month follow-up | 
| Change in Quality of Life on the WHO-5 scale | The investigators expect a larger improvement in perceived quality of life in intervention groups compared to wait-list controls over the course of the three time points | From baseline to post-treatment (9 weeks later) and to 3-month follow-up | 
| Change in Short-Form Health Survey-36 | The investigators expect a significantly larger improvement in quality of life (SF-36-Mental Component Summary Score and SF-36 Physical Component Summary Score) in intervention groups compared to wait-list controls over the course of the three time points. | From baseline to post-treatment (9 weeks later) and to 3-month follow-up | 
| Change in Major Depression Inventory | The investigators expect a significantly larger decrease in depressive symptoms in intervention groups than in wait-list controls over the course of the three time points. | From baseline to post-treatment (9 weeks later) and to 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Promotion, Prevention, Relaxation Response, Meditation, Cortisol