Who Fares Best With Mindfulness Meditation

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862636
• Other study ID #: s66664
• Secondary ID: IRAS ID 313533
• Status: Recruiting
• Start date: February 21, 2023
• Est. completion date: January 2025

Study information

• Verified date: August 2023
• Source: KU Leuven
• Contact: Filip Raes, Prof. dr.
• Phone: +3216325892
• Email: filip.raes[@]kuleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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 for each site) 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Healthy
• Mental Health Issue

Intervention

Behavioral:
• Mindfulness Training
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.

Locations

Country	Name	City	State
Belgium	ZNA Stresskliniek	Antwerp
Belgium	Mindful Me	Deinze
United Kingdom	AccEPT clinic	Exeter

Sponsors (2)

Lead Sponsor	Collaborator
Prof. dr. Filip Raes	University of Exeter

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Previous experience with meditation	An 8-item scale measuring participants' previous experience with meditation including duration of practice and frequency of practice during the last 4 weeks.	Before the MBI
Other	Frequency of mindfulness home practice	A 4-item scale measuring frequency and duration of home practice during the last 4 weeks.	4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
Other	Change in Practice Quality-Mindfulness (PQ-M)	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-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
Other	Intentions of meditation practice	A 2-item scale measuring intentions for meditation practice on a 7-point Likert scale ranging from "never" to "every time I meditate".	4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
Other	Modified version of the Credibility/ Expectancy Questionnaire (CEQ)	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).	Before the MBI, 4-weeks after start of MBI, 8 weeks after start of MBI, and 3 months after the end of the MBI
Other	Session attendance	A 2-item scale measuring number of attended sessions and drop-out.	8 weeks after start of MBI
Primary	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
Primary	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
Primary	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
Primary	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	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.	8 weeks after start of MBI
Secondary	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).	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	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).	Before the MBI
Secondary	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).	Before the MBI
Secondary	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).	Before the MBI
Secondary	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).	Before the MBI
Secondary	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).	Before the MBI