Who Fares Best With Mindfulness Meditation

NCT05862636 | Recruiting

• 2 other identifiers: s66664IRAS ID 313533
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 3

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).

Conditions

Healthy; Depression; Mental Health Issue

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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).

  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

  8 weeks after start of MBI

• Change in Comprehensive Inventory of Mindfulness Experiences - Short Form (CHIME-SF)

  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)

  Before the MBI

• Perseverative Thinking Questionnaire (PTQ)

  Before the MBI

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

  Before the MBI

Other Outcomes (6)

• Previous experience with meditation

  Before the MBI

• Frequency of mindfulness home practice

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

• Change in Practice Quality-Mindfulness (PQ-M)

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

Study Arms (2)

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.

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.

Behavioral: Mindfulness Training

Interventions

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.

Mindfulness centre for general public; Stress clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who enrolled for a Mindfulness-Based Intervention (MBI) at one of the participating study sites.

You may qualify if:

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

You may not qualify if:

• Insufficient knowledge of the Dutch or English language (depending on the study site)
• No internet access

Sponsors & Collaborators

• Prof. dr. Filip Raes: lead
• University of Exeter: collaborator

Study Sites (3)

ZNA Stresskliniek

Antwerp, Belgium

RECRUITING

Mindful Me

Deinze, Belgium

RECRUITING

AccEPT clinic

Exeter, United Kingdom

WITHDRAWN

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Filip Raes, Prof. dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filip Raes, Prof. dr.

CONTACT

+3216325892; filip.raes@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: May 17, 2023
• Study Start: February 21, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The coded, pseudonymized dataset and supporting information (see above) will be available beginning from 3 months and ending 10 years after publication of the research results.
• Access Criteria: The receiving party will be bound by contractual agreement to keep the transferred data confidential at all times, to only process the data for the purpose of the Study or for improving scientific knowledge about mindfulness and is not permitted to link the data with other data which might render the information more identifiable. To this end, appropriate Data Transfer Agreements (DTAs) will be established.

Locations

BE (2); GB (1)