Clinical trial NCT05862636: Who Fares Best With Mindfulness Meditation
Official title: Who Fares Best With Mindfulness Meditation - Understanding the Individual Effects of Mindfulness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Depression
Mental Health Issue
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: University of Exeter
First posted: 2023-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who enrolled for a Mindfulness-Based Intervention (MBI) at one of the participating study sites.

Brief 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. 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.

Eligibility 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

Primary outcomes:
measure: Change in Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
measure: Change in Recovering Quality of Life (ReQol-10)
timeFrame: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
measure: Change in Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
timeFrame: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
measure: Change in Meditation-Related Adverse Effects Scale, Mindfulness-Based Program version (MRAES-MBP)
timeFrame: 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:
measure: Subjective experience of mindfulness practice effects assessed during interview
timeFrame: 8 weeks after start of MBI
measure: Change in Comprehensive Inventory of Mindfulness Experiences - Short Form (CHIME-SF)
timeFrame: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
measure: Brief Dissociative Experiences Scale (DES-B)
timeFrame: Before the MBI
measure: Perseverative Thinking Questionnaire (PTQ)
timeFrame: Before the MBI
measure: Modified version of the Life Events Checklist for DSM-5 (LEC-5)
timeFrame: Before the MBI
measure: International Trauma Questionnaire (ITQ)
timeFrame: Before the MBI
measure: Obsessive Beliefs Questionnaire (OBQ-9)
timeFrame: Before the MBI
Other outcomes:
measure: Previous experience with meditation
timeFrame: Before the MBI
measure: Frequency of mindfulness home practice
timeFrame: 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
measure: Change in Practice Quality-Mindfulness (PQ-M)
timeFrame: 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
measure: Intentions of meditation practice
timeFrame: 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
measure: Modified version of the Credibility/ Expectancy Questionnaire (CEQ)
timeFrame: Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
measure: Session attendance
timeFrame: 8 weeks after start of MBI
Locations:
city: Antwerp
country: Belgium
facility: ZNA Stresskliniek
city: Deinze
country: Belgium
facility: Mindful Me
city: Exeter
country: United Kingdom
facility: AccEPT clinic
Study officials:
affiliation: KU Leuven
name: Filip Raes, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: