Clinical trial NCT02140307: Relaxation-Response-based Mental Health Promotion - Open and Calm 2013
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Psychological
Stress Physiological
Quality of Life
Keywords: Health Promotion
Prevention
Relaxation Response
Meditation
Cortisol
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Nordea-Fonden, Denmark
First posted: 2014-05-16
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in scores on Perceived Stress on Cohen's Perceived Stress Scale
timeFrame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
measure: Cortisol secretion as measured by the cortisol awakening response
timeFrame: From baseline to post-treatment (after 9 weeks)
Secondary outcomes:
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
measure: Change in Quality of Life on the WHO-5 scale
timeFrame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
measure: Change in Short-Form Health Survey-36
timeFrame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
measure: Change in Major Depression Inventory
timeFrame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
Other outcomes:
measure: Changes in physiological stress levels as measured by blood pressure, skin conductance, heart rate variability measures and respiratory measures during resting state (15 minutes).
timeFrame: Baseline to post-treatment (9 weeks)
measure: Basic processes in visual attention
timeFrame: Baseline to post-treatment (9 weeks)
Locations:
city: Copenhagen OE
country: Denmark
facility: Neurobiology Research Unit, dep. 9201, Copenhagen University Hospital (Rigshospitalet)
Study officials:
affiliation: Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet)
name: Christian G Jensen, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Memory Clinic, Copenhagen University Hospital (Rigshospitalet)
name: Steen G Hasselbalch, Professor
role: STUDY_DIRECTOR
affiliation: Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet)
name: Gitte M Knudsen, Professor
role: STUDY_CHAIR
References:
citation: 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.