- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06136676
From the Heart: Comparing the Effects of Spiritual and Secular Meditation on Psychophysiology, Cognition, Mental Health, and Social Functioning in Healthy Adults
From the Heart Multi-Centre Study: Comparing the Effects of Spiritual and Secular Meditation on Psychophysiology, Cognition, Mental Health, and Social Functioning in Healthy Adults
Study Overview
Status
Conditions
Detailed Description
Background
Secular forms of meditation have been widely accepted as an effective tool to promote well-being and as therapeutic strategies. The popularity of such practices, most notably mindfulness meditation, can be attributed to the substantial body of research on their beneficial effects in the past few decades. While these practices are loosely based on Eastern traditions, and actively reduce emotional reactivity, some Western spiritual meditations have retained their God-centred focus and aim to elicit strong emotions. The current study aims to examine the effects of heart-centred contemplation based on Christian and Islamic traditions on mental, physical, cognitive, and social well-being, compare the outcomes of these exercises to mindfulness meditation, and investigate the external correlates of the outcomes.
Aims
The present study aims to recruit healthy adults to investigate and compare the effects of Christian and Islamic heart-centred spiritual meditation to mindfulness meditation (Mindfulness-based stress reduction; MBSR) and waitlist control, respectively. The potential effects will be examined using measures from multiple domains, with a focus on psychophysiology, cognition, mental health, and social functioning. Additionally, the study aims to examine the possible external correlates of the outcomes by testing perspective-taking, affect, religiosity, spiritual experiences, closeness to God, closeness to the offender, and credibility/expectancies about the spiritual meditation program. The study seeks to understand the impact of different types of meditation practices on the well-being of individuals.
Participants
This study will apply a mixed method repeated measures design to examine a three-arm stratified randomised control trial with healthy samples of Christians and Muslims in multiple testing centres, including Hong Kong and India. Assessments will be conducted at three time points: pre-intervention (T1), after intervention (T2), and at a 3-month follow-up (T3). Eligible participants will be first stratified into Christian and Islamic samples and then randomly allocated to one of the three conditions: religious contemplation (either Christian or Islamic spiritual meditation based on their religions), mindfulness meditation, or waitlist control.
Administration of intervention
The intervention will consist of an 8-week app-based program, including approximately 20-minute daily audio-guided instructions of either one of the spiritual meditations or mindfulness meditation. Participants from the waitlist control will not receive any intervention, but they will be given access to Christian or Islamic meditation app after the experiment is completed.
Outcome measures
Outcome measures consist of domains related to interpersonal functioning, physiology, attention, mental health, spirituality.
Primary outcomes will be the interpersonal functioning domain including measures of prosociality, forgiveness, empathy, and perspective taking.
Secondary outcomes include domains concerning physiology, attention, and mental health. Physiology domain encompasses pain threshold, pain intensity, stress reactivity (heart rate and heart rate variability), psychophysiological reactivity associated with forgiveness (heart rate and heart rate variability). Attention domain includes measures of alerting attention, orienting attention, and executive attention networks. Mental health domain involves self-reported stress, depression, anxiety, subjective welling, and positive and negative affect.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chung Fei Ng
- Phone Number: 4407598137034
- Email: ngc97@uni.coventry.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 to 60 years old
- able to read, speak and understand English
- willing to be randomly assigned to all the conditions, with religious affiliation restricting allocation to either the Christian or Islamic type of spiritual meditation conditions
- consider oneself to be a Christian or Muslim and pray at least weekly
Exclusion Criteria:
- currently suffer from any mental health conditions or use medication to manage mental health conditions
- long-term serious physical medical problems, such as liver, brain, kidney, or other life-threatening chronic diseases
- a history of a heart condition, high blood pressure, Raynaud syndrome, diabetes, or musculoskeletal condition
- the current use of anxiolytics/mood stabilizers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Heart-centred spiritual meditation
Intervention 1: Christian contemplation and Intervention 2: Islamic contemplation
|
Participants assigned to this condition will receive daily audio instructions of approximately 20 minutes daily over the course of 8 weeks focused on Christian contemplation delivered through a mobile app.
The intervention will consist of a core contemplative practice focused on heart visualisation based on Christian tradition and prayer recitation with breathing to focus their attention on and connection to God.
Participants assigned to this condition will receive daily audio instructions of approximately 20 minutes daily over the course of 8 weeks, focused on Islamic contemplation delivered through a mobile app.
The intervention will consist of a core contemplative practice focused on heart visualisation based on Islamic tradition and prayer recitation with breathing to focus attention on and connection to God.
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Active Comparator: Mindfulness Meditation (MBRS)
Intervention 3: Mindfulness Meditation (MBRS)
|
Participants assigned to this condition will receive daily audio instructions of approximately 20 minutes daily over the course of 8 week, focused on mindfulness meditation delivered through a mobile app.
The intervention will consist of the mindfulness-based stress reduction program which emphasizes focused attention on breathing and sensations as well as the practice of non-judgemental acceptance of the present experience.
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No Intervention: Waitlist control
No Intervention: Participants in this condition will not receive any intervention and the outcome measures will be only collected at time points T1 and T2.
After T2 testing, they will be given access to either the Christian or Islamic intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interpersonal functioning: Change in Prosociality (1)
Time Frame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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The number of game points (0-10) that a participant is willing to allocate to another individual as measured by the Dictator Game
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Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Interpersonal functioning: Change in Prosociality (2)
Time Frame: Pre-intervention (collected up to 1 week before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Social value orientation scores as measured by the social value orientation slider measure.
The higher scores represent greater prosocial preferences while lower scores represent greater self-interest preferences
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Pre-intervention (collected up to 1 week before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Interpersonal functioning: Change in Prosociality (3)
Time Frame: Post-intervention (collected up to two weeks after the 8-week intervention)
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The percentage of compensation fees that participants are willing to donate to a charity
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Post-intervention (collected up to two weeks after the 8-week intervention)
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Interpersonal functioning: Changes in self-reported Forgiveness
Time Frame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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A self-reported forgiveness scale assessed within a forgiveness task, ranging from 0 (Not at all) to 20 (Completely).
High scores reflect a higher level of forgiveness, while lower scores indicate a lower level of forgiveness
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Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Interpersonal functioning: Changes in self-reported Empathy
Time Frame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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A self-reported empathy scale assessed within a forgiveness task, ranging from 0 (Not at all) to 20 (Completely).
High scores reflect a higher level of empathy, while lower scores indicate a lower level of empathy.
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Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Interpersonal functioning: Change in Perspective Taking
Time Frame: Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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Interpersonal Reactivity Index (IRI) - Perspective Taking scale.
The 7-item Perspective Taking scale from IRI measures one's tendency to take the point of view of others.
Participants are asked to rate how closely the statements describe them on a 5-point Likert scale ranging from A (Does not describe me well) to E (Describes me very well).
The total scores range from 0 - 28.
Higher scores indicate greater perspective-taking
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Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiology: Change in Pain Tolerance
Time Frame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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The duration (in seconds) that a participant endures painful stimulation assessed during an endurance task
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Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Physiology: Change in Pain Intensity
Time Frame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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0-10 Numerical Rating Scale
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Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Physiology: Change in Stress Reactivity (1)
Time Frame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Heart rate
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Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
|
Physiology: Change in Stress Reactivity (2)
Time Frame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Heart rate variability
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Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
|
Physiology: Change in psychophysiological reactivity associated with forgiveness (1)
Time Frame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Heart rate assessed during a forgiveness task.
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Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Physiology: Change in psychophysiological reactivity associated with forgiveness (2)
Time Frame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
|
Heart rate variability assessed during a forgiveness task
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Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Attention: Change in Alerting Attention network
Time Frame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Reaction time assessed through a 10-minute version of Attentional Network Task (CRSD-ANT)
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Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Attention: Change in Orienting Attention network
Time Frame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
|
Reaction time assessed through a 10-minute version of Attentional Network Task (CRSD-ANT)
|
Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Attention: Change in Executive Attention network
Time Frame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
|
Reaction time assessed through a 10-minute version of Attentional Network Task (CRSD-ANT)
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Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
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Mental health: Change in self-reported Stress
Time Frame: Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a 21-item self-report questionnaire that comprises three distinct subscales: depression, anxiety, and stress, with each containing 7 items.
Participants are asked to rate the extent of the statements applied to them over the past week using a 4-point rating scale, ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time").
Higher scores on stress scale reflect a greater severity of the stress symptoms, whereas lower scores indicate a milder experience of these symptoms
|
Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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Mental health: Change in self-reported Depression
Time Frame: Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
|
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21): Depression subscale, ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time").
Higher scores on depression scale reflect a greater severity of the depression symptoms, whereas lower scores indicate a milder experience of these symptoms
|
Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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Mental health: Change in self-reported Anxiety
Time Frame: Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
|
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21): Anxiety subscale, ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time").
Higher scores on anxiety scale reflect a greater severity of the anxiety symptoms, whereas lower scores indicate a milder experience of these symptoms
|
Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
|
Mental health: Change in Subjective Wellbeing
Time Frame: Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
|
Well-Being Index (WHO-5).
WHO-5 is a 5-item self-report questionnaire measuring subjective wellbeing.
Participants are asked to rate their feelings in the past 2 weeks using a 6-Likert scale, ranging from 0 (At no time) to 5 (All of the time).
The raw score is multiplied by 4 and the final scores range from 0-100.
A score of 0 indicates the lowest possible level of wellbeing, whereas a score of 100 reflects the highest possible level of wellbeing
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Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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Mental health: Change in self-report Positive and Negative Affect (1)
Time Frame: Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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International Positive and Negative Affect Schedule (PANAS) Short Form (I-PANAS-SF).
I-PANAS-SF is a 10-item self-report questionnaire measuring 5 items of positive affect and 5 items of negative affect.
Participants are asked to rate their general feelings and emotions on a 5-point Likert scale ranging from 1 (Never) to 5 (Always).
Higher scores indicate a greater level of positive affect, and lower scores represent a lower level of negative affect
|
Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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Mental health: Change in self-report Positive and Negative Affect (2)
Time Frame: Throughout the 8 weeks intervention
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5-item Smiley Face Likert scale within the meditation app.
The scale assesses participants' feelings before and after their daily contemplative / mindfulness practices.
Participants are asked to choose one out of the five emoji faces on the scale to indicate their current feelings ranging from a very sad face to a very happy face
|
Throughout the 8 weeks intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spirituality: Change in Spiritual Experiences
Time Frame: Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
|
The Daily Spiritual Experience Scale (DSES).
DSES is a 16-item self-report questionnaire.
Participants are asked to rate their daily spiritual experiences.
15 items are rated on a 6-point Likert scale from 1 (Many times a day) to 6 (Never or almost never) and 1 item is rated on a 4-point Likert scale from 1 (Not close) to 4 (As close as possible).
Higher scores indicate greater spirituality
|
Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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Spirituality: Change in Closeness to God
Time Frame: Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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Inclusion-of-God-in-the-self scale (adapted from Inclusions of Others in Self scale).
The scale consists of 7 pairs of pictorial circles with one circle of each pair being labelled as Self, and the other circle being labelled as God.
Participants are asked to choose 1 of the 7 pairs of circles that best describes their relationship with God.
The pairs of circles have different degrees of overlap, ranging from the 1st pair (no overlap) to the 7th pair (most overlap).
The greater the overlap in the circles corresponds to a closer relationship with God
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Pre-intervention (collected up to 1 week before the intervention), post-intervention (collected up to 2 weeks after the 8-week intervention), and at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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Spirituality: Religiosity
Time Frame: Pre-intervention (collected up to 1 week before the intervention)
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Duke University Religiosity Index (DUREL).
DUREL is a 5-item self-report questionnaire measuring three major dimensions of religious involvement with three subscales: organizational religious activity (ORA), non-organizational religious activity (NORA), and intrinsic religiosity (IR).
Participants are asked to rate their religious involvement (ORA and NORA) on a 6-point Likert scale ranging from 1 (Never) to 6 (More than once a week/day) and rate their religious beliefs or experience (IR) on a 5-point Likert scale ranging from 1 (Definitely not true) to 5 (Definitely true of me).
Higher scores indicate a higher religiosity
|
Pre-intervention (collected up to 1 week before the intervention)
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Credibility/Expectancy of the meditation practices
Time Frame: Pre-intervention (collected up to 1 week before the intervention)
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Credibility/Expectancy questionnaire.
This is a 4-item self-report questionnaire that assesses participants' beliefs about the efficacy and credibility of the contemplative practices on a 9-point Likert scale from 1 (Not at all) to 9 (Very much).
Higher scores indicate greater positive expectancies
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Pre-intervention (collected up to 1 week before the intervention)
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Closeness to the offender
Time Frame: Pre-intervention (collected up to 3 hours before the intervention)
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The Inclusion-of-Other-in-the-Self scale assessed within the forgiveness task.
It is a pictorial scale consists of seven pairs of circles, with one circle of each pair labelled as Self and the other circle labelled as Other.
Participants are asked to choose the pair of circles that best describes their relationship with the offender.
The pairs of circles have different degrees of overlap, ranging from the 1st pair (no overlap) to the 7th pair (most overlap).
The greater the overlap in the circles, the closer the relationship with the offender
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Pre-intervention (collected up to 3 hours before the intervention)
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Demographics: Age
Time Frame: Pre-intervention (collected up to 1 week before the intervention)
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Self-report assessment
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Pre-intervention (collected up to 1 week before the intervention)
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Demographics: Ethnicity
Time Frame: Pre-intervention (collected up to 1 week before the intervention)
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Self-report assessment
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Pre-intervention (collected up to 1 week before the intervention)
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Demographics: Gender Identity
Time Frame: Pre-intervention (collected up to 1 week before the intervention)
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Self-report assessment
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Pre-intervention (collected up to 1 week before the intervention)
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Demographics: Biological Sex
Time Frame: Pre-intervention (collected up to 1 week before the intervention)
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Self-report assessment
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Pre-intervention (collected up to 1 week before the intervention)
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Socioeconomic Status: Employment status
Time Frame: Pre-intervention (collected up to 1 week before the intervention)
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Self-report assessment
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Pre-intervention (collected up to 1 week before the intervention)
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Socioeconomic Status: Education level
Time Frame: Pre-intervention (collected up to 1 week before the intervention)
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Self-report assessment
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Pre-intervention (collected up to 1 week before the intervention)
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Socioeconomic Status: Annual household income
Time Frame: Pre-intervention (collected up to 1 week before the intervention)
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Self-report assessment
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Pre-intervention (collected up to 1 week before the intervention)
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Potential adverse events in the meditative practices
Time Frame: Post-intervention (collected up to two weeks after the 8-week intervention)
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Self-report unpleasant events and harm questionnaire.
The questionnaire is a self-report measure to assess the unpleasant events and harm in contemplative or mindfulness practices.
It includes Likert ratings and free-text questions about unpleasant feelings and the harm that participants may have experienced during the contemplation or mindfulness practices
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Post-intervention (collected up to two weeks after the 8-week intervention)
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Experiences of the App-based exercises
Time Frame: Post-intervention (collected up to two weeks after the 8-week intervention) and at 3-month follow-up (collected up to 2 weeks following 3 months after the intervention)
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Self-report assessment about participant's experiences with the App-based exercises
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Post-intervention (collected up to two weeks after the 8-week intervention) and at 3-month follow-up (collected up to 2 weeks following 3 months after the intervention)
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Frequency of the contemplative or mindfulness practices after the end of the intervention
Time Frame: at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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Self-report assessment about frequency of participant's practices after the end of the 8-week intervention
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at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
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Qualitative assessment: Themes emerging from participant's meditation diary
Time Frame: Throughout the 8 weeks intervention
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Key themes that emerge from participants' diaries for their reflection on their experiences of the daily meditative practices
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Throughout the 8 weeks intervention
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Qualitative assessment: Themes emerging from participant's daily meditative experiences
Time Frame: Throughout the 8 weeks intervention
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Key themes that emerge from participants' daily meditative experiences assessed within the App
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Throughout the 8 weeks intervention
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Collaborators and Investigators
Publications and helpful links
General Publications
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Study record dates
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Primary Completion (Estimated)
Study Completion (Estimated)
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First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
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Other Study ID Numbers
- TWCF0595
- 0595 (Other Grant/Funding Number: Templeton World Charity Foundation)
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Studies a U.S. FDA-regulated drug product
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