Relaxation-Response-based Mental Health Promotion - Open and Calm 2013 (RR-MHP OC13)

Steen G Hasselbalch

Status: Unknown

Conditions: Stress Physiological; Quality of Life; Stress Psychological

Treatments: Behavioral: Relaxation Response-based Mental Health Promotion (RR-MHP)

Study type: Interventional

Funder types: Other

Identifiers

NCT02140307

RR-MHP-OC13

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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72 participants in 3 patient groups

Meditation training, group format

Experimental group

Description:

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).

Treatment:

Behavioral: Relaxation Response-based Mental Health Promotion (RR-MHP)

Meditation training, individual format

Active Comparator group

Description:

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.

Treatment:

Behavioral: Relaxation Response-based Mental Health Promotion (RR-MHP)

Wait-list control

No Intervention group

Description:

This arm is an inactive wait-list control.