NCT06136676

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

June 6, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

November 13, 2023

Last Update Submit

August 20, 2024

Conditions

Keywords

Christian spiritual meditationIslamic spiritual meditationMindfulnessProsocialityForgivenessEmpathyPainAttentionDepressionStressAnxietyWell-beingHeart-centred spirituality

Outcome Measures

Primary Outcomes (6)

  • 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

    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

    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

    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

    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.

    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

    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

    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

    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)

    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)

    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)

    Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)

  • +10 more secondary outcomes

Other Outcomes (17)

  • Spirituality: Change in Spiritual Experiences

    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)

  • Spirituality: Change in Closeness to God

    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)

  • Spirituality: Religiosity

    Pre-intervention (collected up to 1 week before the intervention)

  • +14 more other outcomes

Study Arms (3)

Heart-centred spiritual meditation

EXPERIMENTAL

Intervention 1: Christian contemplation and Intervention 2: Islamic contemplation

Behavioral: Arm 1 - Heart-Centred Spiritual Meditation: Christian contemplationBehavioral: Arm 1 - Heart-Centred Spiritual Meditation: Islamic contemplation

Mindfulness Meditation (MBRS)

ACTIVE COMPARATOR

Intervention 3: Mindfulness Meditation (MBRS)

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.

Interventions

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.

Heart-centred spiritual meditation

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.

Heart-centred spiritual meditation

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.

Mindfulness Meditation (MBRS)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Little Flower Institute of Social Sciences and Health (LISSAH) college

Calicut, Kerala, 673586, India

NOT YET RECRUITING

Kuriakose Elias College Mannanam

Kottayam, Kerala, 686561, India

RECRUITING

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MeSH Terms

Conditions

AltruismPainDepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsMental DisordersPersonal Satisfaction

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded data analysis. The researcher who analyzes the data will be kept unaware of the information about the groups.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 18, 2023

Study Start

June 6, 2024

Primary Completion

March 1, 2025

Study Completion

December 1, 2025

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations