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

Not Applicable

• Conditions: Stress Psychological; Stress Physiological; Quality of Life
• Interventions: Behavioral: Relaxation Response-based Mental Health Promotion (RR-MHP)

• Registration Number: NCT02140307
• Lead Sponsor: Steen G Hasselbalch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-10
• Status Verified: 2014-05
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-14
• Last Update Submitted: 2014-05-15
• Study First Posted: 2014-05-16
• Last Update Posted: 2014-05-19
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Meditation training, group format	Relaxation Response-based Mental Health Promotion (RR-MHP)	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).
Meditation training, individual format	Relaxation Response-based Mental Health Promotion (RR-MHP)	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.

Primary Outcome Measures

Name	Time	Method
Change in scores on Perceived Stress on Cohen's Perceived Stress Scale	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
Cortisol secretion as measured by the cortisol awakening response	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.

Secondary Outcome Measures

Name	Time	Method
Change in Pittsburgh Sleep Quality Index (PSQI)	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
Change in Quality of Life on the WHO-5 scale	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
Change in Short-Form Health Survey-36	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.
Change in Major Depression Inventory	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.

Trial Locations

Locations (1)

Neurobiology Research Unit, dep. 9201, Copenhagen University Hospital (Rigshospitalet); 🇩🇰 Copenhagen OE, Denmark