HealthyNCT05862636
Who Fares Best With Mindfulness Meditation
An observational study of Healthy and Depression, run by Prof. dr. Filip Raes at 3 sites in 2 countries.
Trial summary
The overall aim of this observational study is to investigate how individual differences influence the effects of mindfulness meditation to uncover for whom mindfulness is beneficial and for whom it may be harmful. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Depression, Mental Health Issue
- What is being tested?
- Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 21 Feb 2023to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults who enrolled for a Mindfulness-Based Intervention (MBI) at one of the participating study sites.
Who may be able to join
- Enrolled in a mindfulness-based intervention at one of the participating sites
Who cannot join
- Insufficient knowledge of the Dutch or English language (depending on the study site)
- No internet access
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Belgium2 sites, 2 recruiting
- Recruiting
ZNA Stresskliniek
Antwerp
- Recruiting
Mindful Me
Deinze
About this study
Official title: Who Fares Best With Mindfulness Meditation - Understanding the Individual Effects of Mindfulness
The overall aim of this observational study is to investigate how individual differences influence the effects of mindfulness meditation to uncover for whom mindfulness is beneficial and for whom it may be harmful. The first objective is to identify the mechanisms underlying the effects of mindfulness meditation on mental health. The second objective is to examine how three candidate factors, namely trauma symptoms, tendency to dissociate, and repetitive negative thinking, influence the effect of mindfulness meditation on mental health.
Adults who enrolled for a Mindfulness-Based Intervention (MBI) at the participating sites (n=120 in total) will be invited to participate. Before the start of the MBI, after half of the sessions, at the end of the MBI and at 3-months follow-up, participants will complete self-report questionnaires. The main outcomes are symptoms of anxiety and depression, quality of life, wellbeing, and adverse effects resulting from the MBI. A subset of participants will be invited for a semi-structured interview after the end of the intervention.
Read more
Update December 2024:
Instead of analysing all subsamples recruited from the different sites separately, the investigators will now analyse all participants from all sites jointly. This amendment has two reasons. First, analysing all participants jointly allows to statistically compare the differences in effects across sites by including a variable that indicates from which site a participant was recruited. If the subsamples are analysed separately, the investigators can only compare the results at face-value but cannot determine whether the effects are statistically different across sites. Second, recruitment could not start at one site because of a restructuring of the mindfulness interventions there and the investigators are experiencing recruitment difficulties in a second site (recruited 5 participants within 1.5 years). Thus, it will not be feasible to recruit 120 participants per site. For those two reasons, the investigators decided to analyse all participants jointly and only recruit 120 participants in total for the quantitative part of this study (see updated study protocol).
Read the detailed description
This project aims to investigate how individual differences influence the effects of mindfulness meditation to gain a first understanding of the personalised effects of mindfulness and uncover for whom mindfulness is beneficial and for whom it may be harmful. In a first step towards a better understanding of the effects of mindfulness mediation on each individual, the investigators aim to identify the mechanisms underlying the effects of mindfulness meditation on mental health and wellbeing (first objective). Based on prior research, the investigators hypothesise that mindfulness meditation exerts its effects via internal awareness, decentering, and non-judgment, but the investigators will also explore other mindfulness skills as potential mechanisms. Knowing the underlying mechanisms will help understand why mindfulness meditation leads to improved mental health in some individuals while it may lead to harm in other individuals. In a second step, the investigators aim to examine specific characteristics of individuals that may influence whether mindfulness meditation has beneficial or possibly harmful effects. Specifically, the investigators aim to examine how three candidate factors, namely trauma symptoms, tendency to dissociate, and repetitive negative thinking, influence the effect of mindfulness meditation on mental health and wellbeing (second objective). Knowing how these individual characteristics influence the effect of mindfulness meditation will clarify for whom mindfulness works best and for whom it may lead to undesired effects.
For both objectives, mental health and wellbeing will be measured using self-report questionnaires to determine the effects of the mindfulness intervention on participants' mental health and wellbeing. To achieve the first objective, the investigators will measure change of different mindfulness skills (the hypothesised mechanisms) with self-report questionnaires across the mindfulness intervention in order to test whether the mindfulness intervention leads to change in mindfulness skills, which in turn leads to change in outcomes. To achieve the second objective, the investigators will measure baseline levels of candidate factors with self-report questionnaires in order to test whether these candidate factors influence in what way the mindfulness intervention affects mental health and wellbeing. Candidate factors are trauma history and symptoms, tendency to dissociate, and repetitive negative thinking. Additionally, the investigators will measure obsessive-compulsive disorder related beliefs as potential candidate factors, as these beliefs influenced the effects of mindfulness in our own clinical practice. Meditation practice-related variables such as frequency, intentions and previous experience will be measured in order to control for potential practice-related effects on mental health.
- Conditions
- Healthy, Depression, Mental Health Issue
- Being tested
- Mindfulness Training
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
All participants will follow a mindfulness course consisting of group sessions of 2-3h duration that are organized (nearly) weekly and are spread over a period of eight weeks. The specific timeline and organisation of the course may differ between the participating sites but all courses will involve a comparable amount of contact hours with the mindfulness trainer. Each session consists of guided experiential mindfulness exercises (e.g., body scan, breathing space, breath focus, walk meditation), sharing of experiences of these exercises, reflections in small groups, psychoeducation, and review of home practices.
The mindfulness courses are based on one of the two most well-known MBIs, Mindfulness-Based Cognitive Therapy (Segal et al., 2002) and Mindfulness-Based Stress Reduction (Kabat-Zinn, 1990), or a combination thereof. Courses follow a standardised protocol with group sessions and daily homework tasks taught by experienced and certified mindfulness trainers.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness centre for general public | Mindfulness course attenders at a mindfulness centre that offers mindfulness trainings for the general public. Participants are thus not selected based on any complaints they may have. Receives: Behavioral: Mindfulness Training | |
| Stress clinic | Mindfulness course attenders at a stress clinic associated with a hospital that offers mindfulness courses for participants with mild complaints, such as stress or worry. Receives: Behavioral: Mindfulness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-4 (PHQ-4)
The PHQ-4 is a 4-item scale that measures symptoms of depression and anxiety over the last two weeks. Items are scored on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
Measured: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
Change in Recovering Quality of Life (ReQol-10)
The ReQol-10 is a 10-item scale that measures quality of life over the last week. Items are scored on a 5-point Likert scale ranging from 0 (none of the time) to 4 (most or all of the time).
Measured: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
Change in Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
The SWEMWBS is a 7-item scale that measures wellbeing over the last two weeks. Items are scored on a 5-point Likert scale ranging from 1 (none of the time) to 5 (all of the time).
Measured: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
Change in Meditation-Related Adverse Effects Scale, Mindfulness-Based Program version (MRAES-MBP)
The MRAES-MBP is a 14-item scale that measures mindfulness-related adverse events over the last four weeks. Items are scored on a 5-point Likert scale ranging from 1 (never) to 5 (very often).
Measured: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
Secondary outcomes (7)
Subjective experience of mindfulness practice effects assessed during interview
Subjective experience of the impact of mindfulness practice on participants' lives and what factors contributed to their experience of mindfulness practice.
Measured: 8 weeks after start of MBI
Change in Comprehensive Inventory of Mindfulness Experiences - Short Form (CHIME-SF)
The CHIME-SF is a 24-item scale that measures mindfulness skills over the last two weeks. Items are scored on a 6-point Likert scale ranging from 1 (never or almost never) to 6 (always or almost always).
Measured: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
Brief Dissociative Experiences Scale (DES-B)
The DES-B is a 8-item scale that measures participants' tendency to dissociate. Items are scored on a VAS scale ranging from 0% (never) to 100% (always).
Measured: Before the MBI
Perseverative Thinking Questionnaire (PTQ)
The PTQ is a 15-item scale that measures repetitive negative thinking. Items are scored on a 5-point Likert scale ranging from 0 (never) to 4 (almost always).
Measured: Before the MBI
Modified version of the Life Events Checklist for DSM-5 (LEC-5)
The LEC-5 is a 17-item scale that measures exposure to traumatic events. Items are scored as either yes (happened to you, you witnessed it, you learned about it happening to a close friend or family member, or you were exposed to it as part of your job) or no (event does not apply to you).
Measured: Before the MBI
International Trauma Questionnaire (ITQ)
The ITQ is a 18-item scale that measures PTSD symptoms. Items are scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).
Measured: Before the MBI
Obsessive Beliefs Questionnaire (OBQ-9)
The OBQ-9 is a 9-item scale that measures obsessive-compulsive disorder related beliefs. Items are scored on a 7-point Likert scale ranging from 1 (disagree very much) to 7 (agree very much).
Measured: Before the MBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start21 Feb 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. dr. Filip Raes
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Sponsor-investigator, Prof. dr. Filip Raes, KU Leuven
- Investigators
- Filip Raes, Prof. dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862636
- Sponsor's protocol ID
- s66664
- Other IDs
- IRAS ID 313533
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2023
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Moderately sensitive information including age, demographic data, all other data coming from questionnaires and interview transcripts will be pseudonymized and shared with other researchers upon request. This dataset will only comprise data of those participants who agreed to their data being shared on the consent form.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Who Fares Best With Mindfulness Meditation - Understanding the Individual Effects of Mindfulness
- ClinicalTrials.gov ID
- NCT05862636
- Acronym / sponsor ID
- s66664
- Conditions
- Healthy, Depression, Mental Health Issue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Prof. dr. Filip RaesUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 17 May 2023 (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.
The overall aim of this observational study is to investigate how individual differences influence the effects of mindfulness meditation to uncover for whom mindfulness is beneficial and for whom it may be harmful. The first objective is to identify the mechanisms underlying the effects of mindfulness meditation on mental health. The second objective is to examine how three candidate factors, namely trauma symptoms, tendency to dissociate, and repetitive negative thinking, influence the effect of mindfulness meditation on mental health.
Adults who enrolled for a Mindfulness-Based Intervention (MBI) at the participating sites (n=120 in total) will be invited to participate. Before the start of the MBI, after half of the sessions, at the end of the MBI and at 3-months follow-up, participants will complete self-report questionnaires. The main outcomes are symptoms of anxiety and depression, quality of life, wellbeing, and adverse effects resulting from the MBI. A subset of participants will be invited for a semi-structured interview after the end of the intervention.
Update December 2024:
Instead of analysing all subsamples recruited from the different sites separately, the investigators will now analyse all participants from all sites jointly. This amendment has two reasons. First, analysing all participants jointly allows to statistically compare the differences in effects across sites by including a variable that indicates from which site a participant was recruited. If the subsamples are analysed separately, the investigators can only compare the results at face-value but cannot determine whether the effects are statistically different across sites. Second, recruitment could not start at one site because of a restructuring of the mindfulness interventions there and the investigators are experiencing recruitment difficulties in a second site (recruited 5 participants within 1.5 years). Thus, it will not be feasible to recruit 120 participants per site. For those two reasons, the investigators decided to analyse all participants jointly and only recruit 120 participants in total for the quantitative part of this study (see updated study protocol).
Detailed description
This project aims to investigate how individual differences influence the effects of mindfulness meditation to gain a first understanding of the personalised effects of mindfulness and uncover for whom mindfulness is beneficial and for whom it may be harmful. In a first step towards a better understanding of the effects of mindfulness mediation on each individual, the investigators aim to identify the mechanisms underlying the effects of mindfulness meditation on mental health and wellbeing (first objective). Based on prior research, the investigators hypothesise that mindfulness meditation exerts its effects via internal awareness, decentering, and non-judgment, but the investigators will also explore other mindfulness skills as potential mechanisms. Knowing the underlying mechanisms will help understand why mindfulness meditation leads to improved mental health in some individuals while it may lead to harm in other individuals. In a second step, the investigators aim to examine specific characteristics of individuals that may influence whether mindfulness meditation has beneficial or possibly harmful effects. Specifically, the investigators aim to examine how three candidate factors, namely trauma symptoms, tendency to dissociate, and repetitive negative thinking, influence the effect of mindfulness meditation on mental health and wellbeing (second objective). Knowing how these individual characteristics influence the effect of mindfulness meditation will clarify for whom mindfulness works best and for whom it may lead to undesired effects.
For both objectives, mental health and wellbeing will be measured using self-report questionnaires to determine the effects of the mindfulness intervention on participants' mental health and wellbeing. To achieve the first objective, the investigators will measure change of different mindfulness skills (the hypothesised mechanisms) with self-report questionnaires across the mindfulness intervention in order to test whether the mindfulness intervention leads to change in mindfulness skills, which in turn leads to change in outcomes. To achieve the second objective, the investigators will measure baseline levels of candidate factors with self-report questionnaires in order to test whether these candidate factors influence in what way the mindfulness intervention affects mental health and wellbeing. Candidate factors are trauma history and symptoms, tendency to dissociate, and repetitive negative thinking. Additionally, the investigators will measure obsessive-compulsive disorder related beliefs as potential candidate factors, as these beliefs influenced the effects of mindfulness in our own clinical practice. Meditation practice-related variables such as frequency, intentions and previous experience will be measured in order to control for potential practice-related effects on mental health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness centre for general public | – | Behavioral: Mindfulness TrainingMindfulness course attenders at a mindfulness centre that offers mindfulness trainings for the general public. Participants are thus not selected based on any complaints they may have. |
| Stress clinic | – | Behavioral: Mindfulness TrainingMindfulness course attenders at a stress clinic associated with a hospital that offers mindfulness courses for participants with mild complaints, such as stress or worry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who enrolled for a Mindfulness-Based Intervention (MBI) at one of the participating study sites.
Key inclusion criteria (1 listed)
- Enrolled in a mindfulness-based intervention at one of the participating sites
Key exclusion criteria (2 listed)
- Insufficient knowledge of the Dutch or English language (depending on the study site)
- No internet access
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 |
|---|---|---|
| Mindfulness TrainingAll participants will follow a mindfulness course consisting of group sessions of 2-3h duration that are organized (nearly) weekly and are spread over a period of eight weeks. The specific timeline and organisation of the course may differ between the participating sites but all courses will involve a comparable amount of contact hours with the mindfulness trainer. Each session consists of guided experiential mindfulness exercises (e.g., body scan, breathing space, breath focus, walk meditation), sharing of experiences of these exercises, reflections in small groups, psychoeducation, and review of home practices. The mindfulness courses are based on one of the two most well-known MBIs, Mindfulness-Based Cognitive Therapy (Segal et al., 2002) and Mindfulness-Based Stress Reduction (Kabat-Zinn, 1990), or a combination thereof. Courses follow a standardised protocol with group sessions and daily homework tasks taught by experienced and certified mindfulness trainers. | Behavioural | Mindfulness centre for general public, Stress clinic |
Primary outcome
Change in Patient Health Questionnaire-4 (PHQ-4)
Time frame: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
The PHQ-4 is a 4-item scale that measures symptoms of depression and anxiety over the last two weeks. Items are scored on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day).
Change in Recovering Quality of Life (ReQol-10)
Time frame: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
The ReQol-10 is a 10-item scale that measures quality of life over the last week. Items are scored on a 5-point Likert scale ranging from 0 (none of the time) to 4 (most or all of the time).
Change in Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Time frame: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
The SWEMWBS is a 7-item scale that measures wellbeing over the last two weeks. Items are scored on a 5-point Likert scale ranging from 1 (none of the time) to 5 (all of the time).
Change in Meditation-Related Adverse Effects Scale, Mindfulness-Based Program version (MRAES-MBP)
Time frame: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
The MRAES-MBP is a 14-item scale that measures mindfulness-related adverse events over the last four weeks. Items are scored on a 5-point Likert scale ranging from 1 (never) to 5 (very often).
7 secondary outcomes
Subjective experience of mindfulness practice effects assessed during interview
Time frame: 8 weeks after start of MBI
Change in Comprehensive Inventory of Mindfulness Experiences - Short Form (CHIME-SF)
Time frame: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
Brief Dissociative Experiences Scale (DES-B)
Time frame: Before the MBI
Perseverative Thinking Questionnaire (PTQ)
Time frame: Before the MBI
Modified version of the Life Events Checklist for DSM-5 (LEC-5)
Time frame: Before the MBI
International Trauma Questionnaire (ITQ)
Time frame: Before the MBI
Obsessive Beliefs Questionnaire (OBQ-9)
Time frame: Before the MBI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: Yes. Moderately sensitive information including age, demographic data, all other data coming from questionnaires and interview transcripts will be pseudonymized and shared with other researchers upon request. This dataset will only comprise data of those participants who agreed to their data being shared on the consent form.
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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.
Filip Raes, Prof. dr. principal investigator
KU Leuven
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Depression, run by Prof. dr. Filip Raes at 3 sites in 2 countries.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filip Raes, Prof. dr. (+3216325892, filip.raes@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-4 (PHQ-4) (time frame: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2025.