Stress PsychologicalRR-MHP OC13NCT02140307
Relaxation-Response-based Mental Health Promotion - Open and Calm 2013
A study testing Relaxation Response-based Mental Health Promotion (RR-MHP) in people with Stress Psychological and Stress Physiological, run by Steen G Hasselbalch at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stress Psychological, Stress Physiological, Quality of Life
- What is being tested?
- Relaxation Response-based Mental Health Promotion (RR-MHP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Neurobiology Research Unit, dep. 9201, Copenhagen University Hospital (Rigshospitalet)
Copenhagen OE, 2100
About this study
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
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
- Being tested
- Relaxation Response-based Mental Health Promotion (RR-MHP)
- Keywords
- Health Promotion, Prevention, Relaxation Response, Meditation, Cortisol
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation Response-based Mental Health Promotion (RR-MHP)Behavioural
Also called Open and Calm, Open & Calm, RR-MHP, Relaxation Response Resiliency Program
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Relaxation Response-based Mental Health Promotion (RR-MHP) |
| Wait-list control | No intervention | This arm is an inactive wait-list control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From baseline to post-treatment (after 9 weeks)
Secondary outcomes (4)
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
Measured: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
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
Measured: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
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.
Measured: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
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.
Measured: From baseline to post-treatment (9 weeks later) and to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steen G Hasselbalch
- Sponsor type
- University, hospital or other
- Collaborators
- Nordea-Fonden, Denmark
- Responsible party
- Sponsor-investigator, Steen G Hasselbalch, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian G Jensen, MSc., Principal investigator, Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet)Steen G Hasselbalch, Professor, Study director, Memory Clinic, Copenhagen University Hospital (Rigshospitalet)Gitte M Knudsen, Professor, Study chair, Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140307
- Sponsor's protocol ID
- RR-MHP-OC13
- Acronym
- RR-MHP OC13
- Status last verified
- May 2014
- First submitted
- 14 May 2014
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26673225
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02140307
- Acronym / sponsor ID
- RR-MHP OC13 / RR-MHP-OC13
- Conditions
- Stress Psychological, Stress Physiological, Quality of Life
- Keywords
- Health Promotion, Prevention, Relaxation Response, Meditation, Cortisol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Steen G HasselbalchUniversity, hospital or other
- Collaborators
- Nordea-Fonden, Denmark
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Sep 2014 (estimated)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meditation training, group format | Experimental | Behavioral: 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 | Active comparator | Behavioral: 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. |
| Wait-list control | No intervention | –This arm is an inactive wait-list control. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation Response-based Mental Health Promotion (RR-MHP)Also: Open and Calm, Open & Calm, RR-MHP, Relaxation Response Resiliency ProgramThe 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). | Behavioural | Meditation training, group format, Meditation training, individual format |
Primary outcome
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
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.
4 secondary outcomes
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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
Change in Short-Form Health Survey-36
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Derived from this study: PubMed 26673225Jensen 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.
- Homepage of the central investigating research unitLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian G Jensen, MSc. principal investigator
Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet)
Steen G Hasselbalch, Professor study director
Memory Clinic, Copenhagen University Hospital (Rigshospitalet)
Gitte M Knudsen, Professor study chair
Neurobiology Research Unit, Copenhagen University Hospital (Rigshospitalet)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Response-based Mental Health Promotion (RR-MHP) in people with Stress Psychological and Stress Physiological, run by Steen G Hasselbalch at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02140307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.