NCT04950543

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

July 5, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2021

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

June 10, 2021

Last Update Submit

February 27, 2023

Conditions

Keywords

Meditation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from Baseline Quality of life at 1 months

Secondary Outcomes (15)

  • Quality of life, PROMIS-29 Profile v2.1

    Baseline, 3 months and 6 months

  • Global Health, PROMIS Scale v1.2

    Baseline, 1 month, 3 months and 6 months

  • Affect regulation, PANAS 10

    Baseline, 1 month, 3 months and 6 months

  • Stress, PSS 4

    Baseline, 1 month, 3 months and 6 months

  • Flourishing, FS 8

    Baseline, 1 month, 3 months and 6 months

  • +10 more secondary outcomes

Other Outcomes (1)

  • Qualitative interviews

    1 month and 6 months

Study Arms (1)

Meditation

Behavioral: Meditation

Interventions

MeditationBEHAVIORAL

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.

Meditation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- All persons registering for the online course

You may qualify if:

  • 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

You may not qualify if:

  • \- Failure to provide informed consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University

Berlin, 14109, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2021

First Posted

July 6, 2021

Study Start

July 5, 2021

Primary Completion

October 17, 2021

Study Completion

October 17, 2021

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations