Relaxation-Response-based Mental Health Promotion - Open and Calm 2013

Quality of Life Clinical Trial

— RR-MHP OC13  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02140307
• Other study ID #: RR-MHP-OC13
• Status: Active, not recruiting
• Phase: N/A
• First received: May 14, 2014
• Last updated: May 15, 2014
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: May 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: September 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Quality of Life
• Stress Physiological
• Stress Psychological

Intervention

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).

Locations

Country	Name	City	State
Denmark	Neurobiology Research Unit, dep. 9201, Copenhagen University Hospital (Rigshospitalet)	Copenhagen OE

Sponsors (2)

Lead Sponsor	Collaborator
Steen G Hasselbalch	Nordea-Fonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Other	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)	No
Primary	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	No
Primary	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)	No
Secondary	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	No
Secondary	Change in Quality of Life on the WHO-5 scale	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Homepage of the central investigating research unit