Prosocial BehaviorNCT06136676
From the Heart: Comparing the Effects of Spiritual and Secular Meditation on Psychophysiology, Cognition, Mental Health, and Social Functioning in Healthy Adults
A study testing Arm 1 - Heart-Centred Spiritual Meditation: Christian contemplation and Arm 1 - Heart-Centred Spiritual Meditation: Islamic contemplation in people with Prosocial Behavior and Forgiveness, run by Coventry University at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosocial Behavior, Forgiveness, Empathy
- What is being tested?
- Arm 1 - Heart-Centred Spiritual Meditation: Christian contemplation and Arm 1 - Heart-Centred Spiritual Meditation: Islamic contemplation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 2 sitesIndia
- Study dates
- 6 Jun 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Not yet recruiting
Little Flower Institute of Social Sciences and Health (LISSAH) college
Calicut, Kerala, 673586
- Recruiting
Kuriakose Elias College Mannanam
Kottayam, Kerala, 686561
About this study
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
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.
Read the 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.
- Conditions
- Prosocial Behavior, Forgiveness, Empathy, Pain, Attention, Depression
- Being tested
- Arm 1 - Heart-Centred Spiritual Meditation: Christian contemplation, Arm 1 - Heart-Centred Spiritual Meditation: Islamic contemplation, Arm 2 - Action Control: Mindfulness Meditation
- Keywords
- Christian spiritual meditation, Islamic spiritual meditation, Mindfulness, Prosociality, Forgiveness, Empathy, Pain, Attention, Depression, Stress, Anxiety, Well-being, Heart-centred spirituality
- Medical subject headings
- Altruism, Pain, Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 - Heart-Centred Spiritual Meditation: Christian contemplationBehavioural
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.
Arm 1 - Heart-Centred Spiritual Meditation: Islamic contemplationBehavioural
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.
Arm 2 - Action Control: Mindfulness MeditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Heart-centred spiritual meditation | Experimental | Intervention 1: Christian contemplation and Intervention 2: Islamic contemplation Receives: Behavioral: Arm 1 - Heart-Centred Spiritual Meditation: Christian contemplation; Behavioral: Arm 1 - Heart-Centred Spiritual Meditation: Islamic contemplation |
| Mindfulness Meditation (MBRS) | Active comparator | Intervention 3: Mindfulness Meditation (MBRS) Receives: Behavioral: Arm 2 - Action Control: Mindfulness Meditation |
| Waitlist control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpersonal functioning: Change in Prosociality (1)
The number of game points (0-10) that a participant is willing to allocate to another individual as measured by the Dictator Game
Measured: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Interpersonal functioning: Change in Prosociality (2)
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
Measured: Pre-intervention (collected up to 1 week before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Interpersonal functioning: Change in Prosociality (3)
The percentage of compensation fees that participants are willing to donate to a charity
Measured: Post-intervention (collected up to two weeks after the 8-week intervention)
Interpersonal functioning: Changes in self-reported Forgiveness
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
Measured: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Interpersonal functioning: Changes in self-reported Empathy
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.
Measured: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Interpersonal functioning: Change in Perspective Taking
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
Measured: 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 (15)
Physiology: Change in Pain Tolerance
The duration (in seconds) that a participant endures painful stimulation assessed during an endurance task
Measured: 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 Pain Intensity
0-10 Numerical Rating Scale
Measured: 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 (1)
Heart rate
Measured: 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)
Heart rate variability
Measured: 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)
Heart rate assessed during a forgiveness task.
Measured: 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 (2)
Heart rate variability assessed during a forgiveness task
Measured: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Attention: Change in Alerting Attention network
Reaction time assessed through a 10-minute version of Attentional Network Task (CRSD-ANT)
Measured: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Attention: Change in Orienting Attention network
Reaction time assessed through a 10-minute version of Attentional Network Task (CRSD-ANT)
Measured: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Attention: Change in Executive Attention network
Reaction time assessed through a 10-minute version of Attentional Network Task (CRSD-ANT)
Measured: Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Mental health: Change in self-reported Stress
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
Measured: 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 self-reported Depression
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
Measured: 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 self-reported Anxiety
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
Measured: 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
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
Measured: 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 self-report Positive and Negative Affect (1)
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
Measured: 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 self-report Positive and Negative Affect (2)
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
Measured: Throughout the 8 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start6 Jun 2024
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (79)Papers the sponsor has linked to this study.
- Other trials for Prosocial BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coventry University
- Sponsor type
- University, hospital or other
- Collaborators
- Donders Centre for Cognitive Neuroimaging, Kuriakose Elias College Mannanam, Little Flower Institute of Social Sciences and Health (LISSAH) College
- Responsible party
- Principal investigator, Miguel Farias, Coventry University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136676
- Sponsor's protocol ID
- TWCF0595
- Other IDs
- 0595
- Status last verified
- Aug 2024
- First submitted
- 13 Nov 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ainsworth B, Eddershaw R, Meron D, Baldwin DS, Garner M. The effect of focused attention and open monitoring meditation on attention network function in healthy volunteers. Psychiatry Res. 2013 Dec 30;210(3):1226-31. doi: 10.1016/j.psychres.2013.09.002. Epub 2013 Oct 14.
PubMed 24135553Aron A, Aron EN, Smollan D. Inclusion of Other in the Self Scale and the structure of interpersonal closeness. Journal of Personality and Social Psychology. 1992; 63(4): 596-612.
Baer R, Crane C, Montero-Marin J, Phillips A, Taylor L, Tickell A, Kuyken W; MYRIAD team. Frequency of Self-reported Unpleasant Events and Harm in a Mindfulness-Based Program in Two General Population Samples. Mindfulness (N Y). 2021;12(3):763-774. doi: 10.1007/s12671-020-01547-8. Epub 2020 Dec 2.
PubMed 33747251Baesler EM, Derlega VJ, Winstead BA, Barbee A. Prayer as Interpersonal Coping in the Lives of Mothers with HIV. Communication & Theatre Arts Faculty Publications. 2003; 26(3-4): 283-295.
Bandura A. On the psychosocial impact and mechanisms of spiritual modeling. The International Journal for the Psychology of Religion. 2003; 13(3): 167-174.
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006; 3(2): 77-101.
Bryant RA, Marosszeky JE, Crooks J, Gurka JA. Elevated resting heart rate as a predictor of posttraumatic stress disorder after severe traumatic brain injury. Psychosom Med. 2004 Sep-Oct;66(5):760-1. doi: 10.1097/01.psy.0000138121.13198.84.
PubMed 15385703Buric I, Brazil IA, van Mulukom V. Individual differences in meditation outcomes. The Oxford Handbook of Meditation. Oxford University Press. 2021; 503-524.
Buric I, Farias M, Jong J, Mee C, Brazil IA. What Is the Molecular Signature of Mind-Body Interventions? A Systematic Review of Gene Expression Changes Induced by Meditation and Related Practices. Front Immunol. 2017 Jun 16;8:670. doi: 10.3389/fimmu.2017.00670. eCollection 2017.
PubMed 28670311Carlson CA, Bacaseta PE, Simanton DA. A controlled evaluation of devotional meditation and progressive relaxation. Journal of Psychology and Theology. 1988; 16(4): 362-368.
Carmo Silva C. The Phenomenology of Meditation: Commonalities and Divergences between Christian Meditation and Hindu Dhyāna. The Oxford Handbook of Meditation. Oxford University Press. 2021; 384-400.
Charles SJ, Farias M, van Mulukom V, Saraswati A, Dein S, Watts F, Dunbar RIM. Blocking mu-opioid receptors inhibits social bonding in rituals. Biol Lett. 2020 Oct;16(10):20200485. doi: 10.1098/rsbl.2020.0485. Epub 2020 Oct 14.
PubMed 33050833Charles SJ, van Mulukom V, Brown JE, Watts F, Dunbar RIM, Farias M. United on Sunday: The effects of secular rituals on social bonding and affect. PLoS One. 2021 Jan 27;16(1):e0242546. doi: 10.1371/journal.pone.0242546. eCollection 2021.
PubMed 33503054Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Collicutt J, Bretherton R, Brickman J. Being Mindful, Being Christian: A guide to mindful discipleship. Monarch Book. 2016.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06136676
- Acronym / sponsor ID
- TWCF0595
- Conditions
- Prosocial Behavior, Forgiveness, Empathy, Pain, Attention, Depression
- Keywords
- Christian spiritual meditation, Islamic spiritual meditation, Mindfulness, Prosociality, Forgiveness, Empathy, Pain, Attention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Coventry UniversityUniversity, hospital or other
- Collaborators
- Donders Centre for Cognitive Neuroimaging, Kuriakose Elias College Mannanam, Little Flower Institute of Social Sciences and Health (LISSAH) College
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Heart-centred spiritual meditation | Experimental | Behavioral: Arm 1 - Heart-Centred Spiritual Meditation: Christian contemplation, Behavioral: Arm 1 - Heart-Centred Spiritual Meditation: Islamic contemplationIntervention 1: Christian contemplation and Intervention 2: Islamic contemplation |
| Mindfulness Meditation (MBRS) | Active comparator | Behavioral: Arm 2 - Action Control: Mindfulness MeditationIntervention 3: Mindfulness Meditation (MBRS) |
| Waitlist control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1 - Heart-Centred Spiritual Meditation: Christian contemplationParticipants 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. | Behavioural | Heart-centred spiritual meditation |
| Arm 1 - Heart-Centred Spiritual Meditation: Islamic contemplationParticipants 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. | Behavioural | Heart-centred spiritual meditation |
| Arm 2 - Action Control: Mindfulness MeditationParticipants 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. | Behavioural | Mindfulness Meditation (MBRS) |
Primary outcome
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)
The number of game points (0-10) that a participant is willing to allocate to another individual as measured by the Dictator Game
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)
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
Interpersonal functioning: Change in Prosociality (3)
Time frame: Post-intervention (collected up to two weeks after the 8-week intervention)
The percentage of compensation fees that participants are willing to donate to a charity
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)
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
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)
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.
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)
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
15 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Mental health: Change in self-report Positive and Negative Affect (2)
Time frame: Throughout the 8 weeks intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background: PubMed 24135553Ainsworth B, Eddershaw R, Meron D, Baldwin DS, Garner M. The effect of focused attention and open monitoring meditation on attention network function in healthy volunteers. Psychiatry Res. 2013 Dec 30;210(3):1226-31. doi: 10.1016/j.psychres.2013.09.002. Epub 2013 Oct 14.
- BackgroundAron A, Aron EN, Smollan D. Inclusion of Other in the Self Scale and the structure of interpersonal closeness. Journal of Personality and Social Psychology. 1992; 63(4): 596-612.
- Background: PubMed 33747251Baer R, Crane C, Montero-Marin J, Phillips A, Taylor L, Tickell A, Kuyken W; MYRIAD team. Frequency of Self-reported Unpleasant Events and Harm in a Mindfulness-Based Program in Two General Population Samples. Mindfulness (N Y). 2021;12(3):763-774. doi: 10.1007/s12671-020-01547-8. Epub 2020 Dec 2.
- BackgroundBaesler EM, Derlega VJ, Winstead BA, Barbee A. Prayer as Interpersonal Coping in the Lives of Mothers with HIV. Communication & Theatre Arts Faculty Publications. 2003; 26(3-4): 283-295.
- BackgroundBandura A. On the psychosocial impact and mechanisms of spiritual modeling. The International Journal for the Psychology of Religion. 2003; 13(3): 167-174.
- BackgroundBraun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006; 3(2): 77-101.
- Background: PubMed 15385703Bryant RA, Marosszeky JE, Crooks J, Gurka JA. Elevated resting heart rate as a predictor of posttraumatic stress disorder after severe traumatic brain injury. Psychosom Med. 2004 Sep-Oct;66(5):760-1. doi: 10.1097/01.psy.0000138121.13198.84.
- BackgroundBuric I, Brazil IA, van Mulukom V. Individual differences in meditation outcomes. The Oxford Handbook of Meditation. Oxford University Press. 2021; 503-524.
- Background: PubMed 28670311Buric I, Farias M, Jong J, Mee C, Brazil IA. What Is the Molecular Signature of Mind-Body Interventions? A Systematic Review of Gene Expression Changes Induced by Meditation and Related Practices. Front Immunol. 2017 Jun 16;8:670. doi: 10.3389/fimmu.2017.00670. eCollection 2017.
- BackgroundCarlson CA, Bacaseta PE, Simanton DA. A controlled evaluation of devotional meditation and progressive relaxation. Journal of Psychology and Theology. 1988; 16(4): 362-368.
- BackgroundCarmo Silva C. The Phenomenology of Meditation: Commonalities and Divergences between Christian Meditation and Hindu Dhyāna. The Oxford Handbook of Meditation. Oxford University Press. 2021; 384-400.
- Background: PubMed 33050833Charles SJ, Farias M, van Mulukom V, Saraswati A, Dein S, Watts F, Dunbar RIM. Blocking mu-opioid receptors inhibits social bonding in rituals. Biol Lett. 2020 Oct;16(10):20200485. doi: 10.1098/rsbl.2020.0485. Epub 2020 Oct 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1 - Heart-Centred Spiritual Meditation: Christian contemplation and Arm 1 - Heart-Centred Spiritual Meditation: Islamic contemplation in people with Prosocial Behavior and Forgiveness, run by Coventry University at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chung Fei Ng (4407598137034, fei0929@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136676, which also lists 79 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.