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
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prosocial Behavior
Forgiveness
Empathy
Pain
Attention
Depression
Stress
Anxiety
Mental Well-being
Keywords: Christian spiritual meditation
Islamic spiritual meditation
Mindfulness
Prosociality
Forgiveness
Empathy
Pain
Attention
Depression
Stress
Anxiety
Well-being
Heart-centred spirituality
Lead sponsor: Coventry University
Sponsor class: OTHER
Collaborators: name: Radboud University, Donders Institute for Brain, Cognition and Behaviour
name: Kuriakose Elias College Mannanam
name: Little Flower Institute of Social Sciences and Health (LISSAH) College
First posted: 2023-11-18
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consists of 3 arms, including:

Arm 1 - experimental groups: Heart-Centred Spiritual Meditation. Within this arm, the interventions encompass Islamic heart-centred contemplation and Christian heart-centred contemplation. Participants allocated to the spiritual meditation groups will receive either Islamic or Christian heart-centred contemplation intervention, depending on their respective religious affiliations.

Arm 2 - active control group: Mindfulness-based Stress Reduction. Participants assigned to the active control group will receive mindfulness intervention. This arm mirrors the time commitment and level of engagement of the contemplation interventions.

Arm 3 - passive control group: Waitlist control. Participants assigned to the waitlist control group will not receive any intervention.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate and compare the effects of Christian and Islamic heart-centred spiritual meditation to mindfulness meditation and waitlist control conditions, respectively, in healthy adults. The potential effects will be studied at multiple levels, with a focus on psychophysiology, cognition, mental health, and social functioning.

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 in 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 tolerance, 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 well-being, and positive and negative affect.

Eligibility criteria: 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.

Primary outcomes:
measure: Interpersonal functioning: Change in Prosociality (1)
timeFrame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Interpersonal functioning: Change in Prosociality (2)
timeFrame: Pre-intervention (collected up to 1 week before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Interpersonal functioning: Change in Prosociality (3)
timeFrame: Post-intervention (collected up to two weeks after the 8-week intervention)
measure: Interpersonal functioning: Changes in self-reported Forgiveness
timeFrame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Interpersonal functioning: Changes in self-reported Empathy
timeFrame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Interpersonal functioning: Change in Perspective Taking
timeFrame: 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)
Secondary outcomes:
measure: Physiology: Change in Pain Tolerance
timeFrame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Physiology: Change in Pain Intensity
timeFrame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Physiology: Change in Stress Reactivity (1)
timeFrame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Physiology: Change in Stress Reactivity (2)
timeFrame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Physiology: Change in psychophysiological reactivity associated with forgiveness (1)
timeFrame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Physiology: Change in psychophysiological reactivity associated with forgiveness (2)
timeFrame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Attention: Change in Alerting Attention network
timeFrame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Attention: Change in Orienting Attention network
timeFrame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Attention: Change in Executive Attention network
timeFrame: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
measure: Mental health: Change in self-reported Stress
timeFrame: 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)
measure: Mental health: Change in self-reported Depression
timeFrame: 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)
measure: Mental health: Change in self-reported Anxiety
timeFrame: 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)
measure: Mental health: Change in Subjective Wellbeing
timeFrame: 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)
measure: Mental health: Change in self-report Positive and Negative Affect (1)
timeFrame: 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)
measure: Mental health: Change in self-report Positive and Negative Affect (2)
timeFrame: Throughout the 8 weeks intervention
Other outcomes:
measure: Spirituality: Change in Spiritual Experiences
timeFrame: 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)
measure: Spirituality: Change in Closeness to God
timeFrame: 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)
measure: Spirituality: Religiosity
timeFrame: Pre-intervention (collected up to 1 week before the intervention)
measure: Credibility/Expectancy of the meditation practices
timeFrame: Pre-intervention (collected up to 1 week before the intervention)
measure: Closeness to the offender
timeFrame: Pre-intervention (collected up to 3 hours before the intervention)
measure: Demographics: Age
timeFrame: Pre-intervention (collected up to 1 week before the intervention)
measure: Demographics: Ethnicity
timeFrame: Pre-intervention (collected up to 1 week before the intervention)
measure: Demographics: Gender Identity
timeFrame: Pre-intervention (collected up to 1 week before the intervention)
measure: Demographics: Biological Sex
timeFrame: Pre-intervention (collected up to 1 week before the intervention)
measure: Socioeconomic Status: Employment status
timeFrame: Pre-intervention (collected up to 1 week before the intervention)
measure: Socioeconomic Status: Education level
timeFrame: Pre-intervention (collected up to 1 week before the intervention)
measure: Socioeconomic Status: Annual household income
timeFrame: Pre-intervention (collected up to 1 week before the intervention)
measure: Potential adverse events in the meditative practices
timeFrame: Post-intervention (collected up to two weeks after the 8-week intervention)
measure: Experiences of the App-based exercises
timeFrame: 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)
measure: Frequency of the contemplative or mindfulness practices after the end of the intervention
timeFrame: at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
measure: Qualitative assessment: Themes emerging from participant's meditation diary
timeFrame: Throughout the 8 weeks intervention
measure: Qualitative assessment: Themes emerging from participant's daily meditative experiences
timeFrame: Throughout the 8 weeks intervention
Locations:
city: Calicut
country: India
facility: Little Flower Institute of Social Sciences and Health (LISSAH) college
state: Kerala
city: Kottayam
country: India
facility: Kuriakose Elias College Mannanam
state: Kerala
Study officials:
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