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Who Fares Best With Mindfulness Meditation

Sponsor: Prof. dr. Filip Raes

NCT ID: NCT05862636

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Mindfulness Training (behavioural)
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
Mindfulness Training — behavioural: 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.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at who does best with mindfulness meditation. It includes healthy people and people with depression or other mental health problems. Everyone in the study is already taking part in a mindfulness course at one of the study sites.

Who can take part

  • You are already signed up for a mindfulness course at one of the places running this study.

Who may not be able to

  • You do not know enough Dutch or English (this depends on the study site).
  • You do not have internet access.

What taking part involves

  • • Taking part in a mindfulness course at one of the study sites.
  • • Any other study tasks: Not stated — ask the trial team.

Time commitment: Taking part involves a mindfulness course at a study site. Number of visits and how long the study lasts: Not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
120
Started
2023-02-21
Last checked
2025-01

Plain English Summary

What is this study?

  • • Testing a new treatment for healthy
  • • Clinical study - 120 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with healthy

Where?

  • • Exeter - AccEPT clinic

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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.

HealthyDepressionMental Health Issue

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Enrolled in a mindfulness-based intervention at one of the participating sites

Who cannot take part

  • ✗Insufficient knowledge of the Dutch or English language (depending on the study site)
  • ✗No internet access
See the full criteria
Inclusion Criteria: * Enrolled in a mindfulness-based intervention at one of the participating sites Exclusion Criteria: * Insufficient knowledge of the Dutch or English language (depending on the study site) * No internet access

Where Is This Study? (1 UK site)

AccEPT clinic

Exeter, United Kingdom

WITHDRAWN

How to Get in Touch

Filip Raes, Prof. dr.

Sponsor contact

CONTACT

+3216325892 filip.raes@kuleuven.be
Data sourced from ClinicalTrials.gov · Last verified: 2025-01