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

May 15, 2014 updated by: Steen G Hasselbalch

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen OE, Denmark, 2100
        • Neurobiology Research Unit, dep. 9201, Copenhagen University Hospital (Rigshospitalet)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meditation training, group format

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)
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).
Other Names:
  • Relaxation Response Resiliency Program
  • Open and Calm
  • Open & Calm
  • RR-MHP
  • 3RP
Active Comparator: Meditation training, individual format
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)
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).
Other Names:
  • Relaxation Response Resiliency Program
  • Open and Calm
  • Open & Calm
  • RR-MHP
  • 3RP
No Intervention: Wait-list control
This arm is an inactive wait-list control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: From baseline to post-treatment (after 9 weeks)

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)
Time Frame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
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
Time Frame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
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
Time Frame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
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
Time Frame: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
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

Other Outcome Measures

Outcome Measure
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).
Time Frame: Baseline to post-treatment (9 weeks)
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)
Basic processes in visual attention
Time Frame: Baseline to post-treatment (9 weeks)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steen G Hasselbalch

Collaborators

Nordea-Fonden, Denmark

Investigators

  • Principal Investigator: Christian G Jensen, MSc., Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet)
  • Study Director: Steen G Hasselbalch, Professor, Memory Clinic, Copenhagen University Hospital (Rigshospitalet)
  • Study Chair: Gitte M Knudsen, Professor, Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RR-MHP-OC13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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