Overview

This trial is active, not recruiting.

Conditions stress psychological, stress physiological, quality of life
Treatment relaxation response-based mental health promotion (rr-mhp)
Sponsor Steen G Hasselbalch
Collaborator Nordea-Fonden, Denmark
Start date January 2013
End date October 2013
Trial size 72 participants
Trial identifier NCT02140307, RR-MHP-OC13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(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).
relaxation response-based mental health promotion (rr-mhp) Open and Calm
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).
(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.
relaxation response-based mental health promotion (rr-mhp) Open and Calm
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).
(No Intervention)
This arm is an inactive wait-list control.

Primary Outcomes

Measure
Change in scores on Perceived Stress on Cohen's Perceived Stress Scale
time frame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
Cortisol secretion as measured by the cortisol awakening response
time frame: From baseline to post-treatment (after 9 weeks)

Secondary Outcomes

Measure
Change in Pittsburgh Sleep Quality Index (PSQI)
time frame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
Change in Quality of Life on the WHO-5 scale
time frame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
Change in Short-Form Health Survey-36
time frame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
Change in Major Depression Inventory
time frame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

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
Principal investigator Christian G Jensen, MSc.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.