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NCT Number: NCT05862636

Who Fares Best With Mindfulness Meditation

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).

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Key information

Conditions

Healthy Behavior Behavioral Symptoms Depression Mental Health Issue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ZNA Stresskliniek, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Training

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. Subjective experience of mindfulness practice effects assessed during interview

    Time frame: 8 weeks after start of MBI

    Subjective experience of the impact of mindfulness practice on participants' lives and what factors contributed to their experience of mindfulness practice.

  2. 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

    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).

  3. Brief Dissociative Experiences Scale (DES-B)

    Time frame: Before the MBI

    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).

  4. Perseverative Thinking Questionnaire (PTQ)

    Time frame: Before the MBI

    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).

  5. Modified version of the Life Events Checklist for DSM-5 (LEC-5)

    Time frame: Before the MBI

    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).

  6. International Trauma Questionnaire (ITQ)

    Time frame: Before the MBI

    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).

  7. Obsessive Beliefs Questionnaire (OBQ-9)

    Time frame: Before the MBI

    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).

Other outcomes

  1. Previous experience with meditation

    Time frame: Before the MBI

    An 8-item scale measuring participants' previous experience with meditation including duration of practice and frequency of practice during the last 4 weeks.

  2. Frequency of mindfulness home practice

    Time frame: 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI

    A 4-item scale measuring frequency and duration of home practice during the last 4 weeks.

  3. Change in Practice Quality-Mindfulness (PQ-M)

    Time frame: 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI

    The PQ-M is a 6-item scale that measures quality of mindfulness practice during the last meditation session. Items are scored on a VAS scale ranging from 0% (the statement reflects my experience none of the time) to 100% (the statement reflects my experience all of the time).

  4. Intentions of meditation practice

    Time frame: 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI

    A 2-item scale measuring intentions for meditation practice on a 7-point Likert scale ranging from "never" to "every time I meditate".

  5. Modified version of the Credibility/ Expectancy Questionnaire (CEQ)

    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 CEQ is a 4-item scale that measures training expectancy. Items are scored on a 9-point Likert scale ranging from 1 (not at all) to 9 (very much).

  6. Session attendance

    Time frame: 8 weeks after start of MBI

    A 2-item scale measuring number of attended sessions and drop-out.

Study contacts

Contact information is provided by the study sponsor or research team.

Filip Raes, Prof. dr.

CONTACT

[email protected]

+3216325892

Sponsors and collaborators

Lead sponsor

Prof. dr. Filip Raes

Other

Collaborators

  • University of Exeter

Registry information

Official study title

Who Fares Best With Mindfulness Meditation - Understanding the Individual Effects of Mindfulness

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 17, 2023
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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