Quality of LifeNCT04950543
Effects of an Online Meditation Course on Quality of Life
An observational study of Quality of Life, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Many interventions in the field of meditation are becoming increasingly popular and have gained worldwide acceptance over the past years, both in terms of health, but also psychological aspects. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 374 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jul 2021to 17 Oct 2021
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - All persons registering for the online course
Who may be able to join
- Age: 18 years or older
- All persons registering for the online course
- Internet access
- Sufficient language skills, as well as cognitive and physical abilities, to participate in an online survey lasting approximately 30 minutes
- Active consent to the online consent form
Who cannot join
- Failure to provide informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Online Meditation Course on Quality of Life and Positive Emotions - a Prospective Observational Study (EXPAN Study)
Many interventions in the field of meditation are becoming increasingly popular and have gained worldwide acceptance over the past years, both in terms of health, but also psychological aspects. On the other hand, controversial and sometimes hypercritical positions are on the rise, questioning the positive effects of meditation on health due to the limited availability of high-quality scientific data. With regard to a large number of meditation interventions, the systematic exploration of procedures that have not yet been scientifically evaluated - also in online settings - is a meaningful contribution to meditation research.
- Conditions
- Quality of Life
- Being tested
- Meditation
- Keywords
- Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
An online survey will be offered to participants who have enrolled in a 21-day meditation online course. The survey will be conducted using mobile website technology before and after the online course and additionally after 3 and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Meditation | Not described Receives: Behavioral: Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life, PROMIS-29 Profile v2.1
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Measured: Change from Baseline Quality of life at 1 months
Secondary outcomes (15)
Quality of life, PROMIS-29 Profile v2.1
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Measured: Baseline, 3 months and 6 months
Global Health, PROMIS Scale v1.2
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Measured: Baseline, 1 month, 3 months and 6 months
Affect regulation, PANAS 10
The scale ranges from 1 to 5, where 1 is the lowest level and 5 is the highest level.
Measured: Baseline, 1 month, 3 months and 6 months
Stress, PSS 4
The scale ranges from 0 to 16, where 0 is the lowest level and 16 is the highest level.
Measured: Baseline, 1 month, 3 months and 6 months
Flourishing, FS 8
The scale ranges from 8 to 56, where 8 is the lowest level and 56 is the highest level.
Measured: Baseline, 1 month, 3 months and 6 months
Resilience, CD-RISC 10
The scale ranges from 0 to 4, where 0 is the lowest level and 40 is the highest level.
Measured: Baseline, 1 month, 3 months and 6 months
Mysticism, HMS-8
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Measured: Baseline, 1 month, 3 months and 6 months
Self-efficacy, ASKU
The scale ranges from 1 to 5, where 1 is the lowest level and 5 is the highest level.
Measured: Baseline, 1 month, 3 months and 6 months
Awe and Gratitude, GrAw-7
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Measured: Baseline, 1 month, 3 months and 6 months
Spirituality, ASP
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Measured: Baseline, 1 month, 3 months and 6 months
Sedentary behavior
Duration in minutes
Measured: Baseline, 1 month, 3 months and 6 months
Sporting activity
Duration in minutes
Measured: Baseline, 1 month, 3 months and 6 months
Relaxation behavior
Duration in minutes
Measured: Baseline, 1 month, 3 months and 6 months
Alcohol consumption
Assessed retrospectively (last 1 month) with self-designed question
Measured: Baseline, 1 month, 3 months and 6 months
Cigarettes
Assessed retrospectively (last 1 month) with self-designed question
Measured: Baseline, 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start5 Jul 2021
- Primary completion17 Oct 2021
- Study completion17 Oct 2021
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 Quality of LifeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950543
- Sponsor's protocol ID
- EXPAN
- Status last verified
- Feb 2023
- First submitted
- 10 Jun 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Figura HM, Saha FJ, Seibt S, Haller H, Bringmann HC, Kessler CS, Kugler J, Cramer H, Michalsen A, Kandil FI, Jeitler M. Effects of an Online Meditation Course on Quality of Life and Positive Emotions: A Prospective Observational Study (EXPANSION Study). J Integr Complement Med. 2024 Jun;30(6):518-531. doi: 10.1089/jicm.2023.0099. Epub 2023 Nov 21.
PubMed 38011030
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Online Meditation Course on Quality of Life and Positive Emotions - a Prospective Observational Study (EXPAN Study)
- ClinicalTrials.gov ID
- NCT04950543
- Acronym / sponsor ID
- EXPAN
- Conditions
- Quality of Life
- Keywords
- Meditation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- 17 Oct 2021 (actual)
- First posted
- 6 Jul 2021 (actual)
- 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.
Many interventions in the field of meditation are becoming increasingly popular and have gained worldwide acceptance over the past years, both in terms of health, but also psychological aspects. On the other hand, controversial and sometimes hypercritical positions are on the rise, questioning the positive effects of meditation on health due to the limited availability of high-quality scientific data. With regard to a large number of meditation interventions, the systematic exploration of procedures that have not yet been scientifically evaluated - also in online settings - is a meaningful contribution to meditation research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meditation | – | Behavioral: Meditation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - All persons registering for the online course
Key inclusion criteria (5 listed)
- Age: 18 years or older
- All persons registering for the online course
- Internet access
- Sufficient language skills, as well as cognitive and physical abilities, to participate in an online survey lasting approximately 30 minutes
- Active consent to the online consent form
Key exclusion criteria (1 listed)
- Failure to provide informed consent to participate in the study
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 |
|---|---|---|
| MeditationAn online survey will be offered to participants who have enrolled in a 21-day meditation online course. The survey will be conducted using mobile website technology before and after the online course and additionally after 3 and 6 months. | Behavioural | Meditation |
Primary outcome
Quality of life, PROMIS-29 Profile v2.1
Time frame: Change from Baseline Quality of life at 1 months
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
15 secondary outcomes
Quality of life, PROMIS-29 Profile v2.1
Time frame: Baseline, 3 months and 6 months
Global Health, PROMIS Scale v1.2
Time frame: Baseline, 1 month, 3 months and 6 months
Affect regulation, PANAS 10
Time frame: Baseline, 1 month, 3 months and 6 months
Stress, PSS 4
Time frame: Baseline, 1 month, 3 months and 6 months
Flourishing, FS 8
Time frame: Baseline, 1 month, 3 months and 6 months
Resilience, CD-RISC 10
Time frame: Baseline, 1 month, 3 months and 6 months
Mysticism, HMS-8
Time frame: Baseline, 1 month, 3 months and 6 months
Self-efficacy, ASKU
Time frame: Baseline, 1 month, 3 months and 6 months
Awe and Gratitude, GrAw-7
Time frame: Baseline, 1 month, 3 months and 6 months
Spirituality, ASP
Time frame: Baseline, 1 month, 3 months and 6 months
Sedentary behavior
Time frame: Baseline, 1 month, 3 months and 6 months
Sporting activity
Time frame: Baseline, 1 month, 3 months and 6 months
Relaxation behavior
Time frame: Baseline, 1 month, 3 months and 6 months
Alcohol consumption
Time frame: Baseline, 1 month, 3 months and 6 months
Cigarettes
Time frame: Baseline, 1 month, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 38011030Figura HM, Saha FJ, Seibt S, Haller H, Bringmann HC, Kessler CS, Kugler J, Cramer H, Michalsen A, Kandil FI, Jeitler M. Effects of an Online Meditation Course on Quality of Life and Positive Emotions: A Prospective Observational Study (EXPANSION Study). J Integr Complement Med. 2024 Jun;30(6):518-531. doi: 10.1089/jicm.2023.0099. Epub 2023 Nov 21.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Charite University, Berlin, Germany at 1 site in Germany.
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 1 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: finished, as of the sponsor's last update on 1 Mar 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of life, PROMIS-29 Profile v2.1 (time frame: Change from Baseline Quality of life at 1 months). 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 NCT04950543, 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 1 Mar 2023.