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| Name | Class |
|---|---|
| Nordea-Fonden, Denmark | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meditation training, group format | Experimental | 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). |
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| Meditation training, individual format | Active Comparator | 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. |
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| Wait-list control | No Intervention | This arm is an inactive wait-list control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relaxation Response-based Mental Health Promotion (RR-MHP) | Behavioral | 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). |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in physiological stress levels as measured by blood pressure, skin conductance, heart rate variability measures and respiratory measures during resting state (15 minutes). | The investigators expect larger improvements in intervention groups than in wait-list controls. Due to logistics, only N = 48 were tested physiologically. | Baseline to post-treatment (9 weeks) |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Christian G Jensen, MSc. | Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet) | Principal Investigator |
| Steen G Hasselbalch, Professor | Memory Clinic, Copenhagen University Hospital (Rigshospitalet) | Study Director |
| Gitte M Knudsen, Professor | Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurobiology Research Unit, dep. 9201, Copenhagen University Hospital (Rigshospitalet) | Copenhagen OE | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26673225 | Derived | Jensen CG, Lansner J, Petersen A, Vangkilde SA, Ringkobing SP, Frokjaer VG, Adamsen D, Knudsen GM, Denninger JW, Hasselbalch SG. Open and Calm--a randomized controlled trial evaluating a public stress reduction program in Denmark. BMC Public Health. 2015 Dec 16;15:1245. doi: 10.1186/s12889-015-2588-2. |
| Label | URL |
|---|---|
| Homepage of the central investigating research unit | View source |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D002147 | Calmodulin |
| ID | Term |
|---|---|
| D052139 | Intracellular Calcium-Sensing Proteins |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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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 |
| Basic processes in visual attention | The investigators expect larger improvements in intervention groups than wait-list controls for the speed of visual processing (threshold of conscious perception measured in ms) on the Theory of Visual Attention (TVA) task developed at the Center for Visual Cognition, Copenhagen University. The investigators expect a lowered threshold for conscious, visual perception (the TVA-t0 parameter) since they have demonstrated this effect after meditation-based training in a previous study (Jensen et al., 2012, J. Exp. Psych. Gen., MBSR affects Attention) | Baseline to post-treatment (9 weeks) |
| D002135 | Calcium-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |