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Идёт набор NCT06136676

From the Heart: Comparing the Effects of Spiritual and Secular Meditation on Psychophysiology, Cognition, Mental Health, and Social Functioning in Healthy Adults

Без фазы С лечением Prosocial Behavior Forgiveness Empathy Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Arm 1 - Heart-Centred Spiritual Meditation: Christian contemplation, Arm 1 - Heart-Centred Spiritual Meditation: Islamic contemplation, Arm 2 - Action Control: Mindfulness Meditation.
Кому может быть актуально
Состояния в реестре: Prosocial Behavior, Forgiveness, Empathy, Pain. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Arm 1 - Heart-Centred Spiritual Meditation: Christian 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.
  • Поведенческое Arm 1 - Heart-Centred Spiritual Meditation: 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 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.
  • Поведенческое Arm 2 - Action Control: Mindfulness 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.

Первичные конечные точки

  • Interpersonal functioning: Change in Prosociality (1) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Post-intervention (collected up to two weeks after the 8-week intervention)]
  • Interpersonal functioning: Changes in self-reported Forgiveness [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]
Вторичные конечные точки (12)
  • Physiology: Change in Pain Tolerance [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Индия · 2 центра
  • Little Flower Institute of Social Sciences and Health (LISSAH) college — Calicut
  • Kuriakose Elias College Mannanam — Kottayam

Публикации

  • 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. PMID 24135553
  • Aron 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. PMID 33747251
  • Baesler 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. PMID 15385703
  • Buric I, Brazil IA, van Mulukom V. Individual differences in meditation outcomes. The Oxford Handbook of Meditation. Oxford University Press. 2021; 503-524.

Идентификаторы

NCT: NCT06136676 · TWCF0595 · 0595

Первоисточники (государственные реестры)

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