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

NCT02140307 | Unknown DMC

• 1 other identifier: RR-MHP-OC13
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Psychological; Stress Physiological; Quality of Life

Keywords

Health Promotion; Prevention; Relaxation Response; Meditation; Cortisol

Outcome Measures

Primary Outcomes (2)

• 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

• 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)

Secondary Outcomes (4)

• Change in Pittsburgh Sleep Quality Index (PSQI)

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

• Change in Quality of Life on the WHO-5 scale

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

• Change in Short-Form Health Survey-36

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

• Change in Major Depression Inventory

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

Other Outcomes (2)

• Changes in physiological stress levels as measured by blood pressure, skin conductance, heart rate variability measures and respiratory measures during resting state (15 minutes).

  Baseline to post-treatment (9 weeks)

• Basic processes in visual attention

  Baseline to post-treatment (9 weeks)

Study Arms (3)

Meditation training, group format

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).

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

Meditation training, individual format

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.

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

Wait-list control

NO INTERVENTION

This arm is an inactive wait-list control.

Interventions

Relaxation Response-based Mental Health Promotion (RR-MHP) BEHAVIORAL

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).

Also known as: Open and Calm, Open & Calm, RR-MHP, Relaxation Response Resiliency Program, 3RP

Meditation training, group format; Meditation training, individual format

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Steen G Hasselbalch: lead
• Nordea-Fonden, Denmark: collaborator

Study Sites (1)

Neurobiology Research Unit, dep. 9201, Copenhagen University Hospital (Rigshospitalet)

Copenhagen OE, 2100, Denmark

Location

Related Publications (1)

• Jensen CG, Lansner J, Petersen A, Vangkilde SA, Ringkobing SP, Frokjaer VG, Adamsen D, Knudsen GM, Denninger JW, Hasselbalch SG. Open and Calm--a randomized controlled trial evaluating a public stress reduction program in Denmark. BMC Public Health. 2015 Dec 16;15:1245. doi: 10.1186/s12889-015-2588-2.

  PMID: 26673225 DERIVED

Related Links

• Homepage of the central investigating research unit

MeSH Terms

Conditions

Stress, Psychological

Interventions

Calmodulin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Intracellular Calcium-Sensing Proteins; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Calcium-Binding Proteins; Carrier Proteins; Proteins

Study Officials

• Christian G Jensen, MSc.

  Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet)

  PRINCIPAL INVESTIGATOR

• Steen G Hasselbalch, Professor

  Memory Clinic, Copenhagen University Hospital (Rigshospitalet)

  STUDY DIRECTOR

• Gitte M Knudsen, Professor

  Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, dr. med.

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 16, 2014
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: September 1, 2014
• Last Updated: May 19, 2014

Record last verified: 2014-05

Locations

DK (1)