Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06136676
Other study ID # TWCF0595
Secondary ID 0595
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date December 2025

Study information

Verified date November 2023
Source Coventry University
Contact Chung Fei Ng
Phone 4407598137034
Email ngc97@uni.coventry.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The potential effects will be studied at multiple levels, with a focus on psychophysiology, cognition, mental health, and social functioning.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 288
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Behavioral:
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.
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.
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.

Locations

Country Name City State
China The University of Hong Kong Hong Kong
India MES College Marampally Aluva Kerala
India Kuriakose Elias College Mannanam Kottayam Kerala

Sponsors (5)

Lead Sponsor Collaborator
Coventry University Kuriakose Elias College Mannanam, MES College Marampally, Radboud University, Donders Institute for Brain, Cognition and Behaviour, The University of Hong Kong

Countries where clinical trial is conducted

China,  India, 

References & Publications (78)

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. — View Citation

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. — View Citation

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. — View Citation

Buric 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. — View Citation

Carlson 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 Dhyana. 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. — View Citation

Charles 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. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. — View Citation

Collicutt J, Bretherton R, Brickman J. Being Mindful, Being Christian: A guide to mindful discipleship. Monarch Book. 2016.

Condon P, DeSteno D. Enhancing compassion: Social psychological perspectives. The Oxford Handbook of Compassion Science. Oxford University Press. 2017.

Creswell JD, Pacilio LE, Lindsay EK, Brown KW. Brief mindfulness meditation training alters psychological and neuroendocrine responses to social evaluative stress. Psychoneuroendocrinology. 2014 Jun;44:1-12. doi: 10.1016/j.psyneuen.2014.02.007. Epub 2014 Feb 23. — View Citation

Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28. — View Citation

Davis M. Measuring individual differences in empathy: Evidence for a multidimensional approach. Journal of Personality and Social Psychology. 1983; 44(1): 113-126.

Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886. — View Citation

Farias M, Brazier D, Lalljee M. Introduction: Understanding and Studying Meditation. The Oxford Handbook of Meditation. Oxford University Press. 2021; 2-17.

Farias M, Maraldi E, Wallenkampf KC, Lucchetti G. Adverse events in meditation practices and meditation-based therapies: a systematic review. Acta Psychiatr Scand. 2020 Nov;142(5):374-393. doi: 10.1111/acps.13225. Epub 2020 Aug 21. — View Citation

Farias M, van Mulukom V, Kahane G, Kreplin U, Joyce A, Soares P, Oviedo L, Hernu M, Rokita K, Savulescu J, Mottonen R. Supernatural Belief Is Not Modulated by Intuitive Thinking Style or Cognitive Inhibition. Sci Rep. 2017 Nov 8;7(1):15100. doi: 10.1038/s41598-017-14090-9. — View Citation

Farias M, Wikholm C. The Buddha Pill: Can Meditation Change You? Watkins. 2019.

Ferreira-Valente A, Van Dyke BP, Day MA, Teotonio do Carmo C, Pais-Ribeiro J, Pimenta F, Costa RM, Jensen MP. Immediate Effects of Hypnosis, Mindfulness Meditation, and Prayer on Cold Pressor Outcomes: A Four-Arm Parallel Experimental Study. J Pain Res. 2022 Dec 23;15:4077-4096. doi: 10.2147/JPR.S388082. eCollection 2022. — View Citation

Forsythe R, Horowitz JL, Savin N, Sefton M . Fairness in Simple Bargaining Experiments. Games and Economic Behavior. 1994b; 6(3): 347-369.

Fox K, Cahn R. Meditation and the brain in health and in disease. The Oxford Handbook of Meditation. Oxford University Press. 2021.

Fredrickson BL. Positive Emotions Broaden and Build. Advances in Experimental Social Psychology. 2013; 47: 1-53

Goyal M, Rusch H. Mindfulness-based interventions in the treatment of physical conditions. The Oxford Handbook of Meditation. Oxford University Press. 2021; 1-25

Guroglu B, van den Bos W, Crone EA. Fairness considerations: increasing understanding of intentionality during adolescence. J Exp Child Psychol. 2009 Dec;104(4):398-409. doi: 10.1016/j.jecp.2009.07.002. Epub 2009 Aug 11. — View Citation

Hines EA, Brown GE . The cold pressor test for measuring the reactibility of the blood pressure: Data concerning 571 normal and hypertensive subjects. American Heart Journal. 1936; 11(1): 1-9.

Hisham AR. Towards a systematic Qura'nic theory of personality. Mental Health, Religion & Culture. 2012; 15(3): 217-233.

Kabat-Zin J. Full Catastrophe Living: Using the Wisdom of Your Body and Mind to Face Stress, Pain, and Illness. Penguin Random House. 2013.

Kabat-Zinn J. Mindfulness-based interventions in context: Past, present, and future. Clinical Psychology: Science and Practice. 2003; 10(2): 144-156.

Karremans JC, van Schie HT, van Dongen I, Kappen G, Mori G, van As S, Ten Bokkel IM, van der Wal RC. Is mindfulness associated with interpersonal forgiveness? Emotion. 2020 Mar;20(2):296-310. doi: 10.1037/emo0000552. Epub 2019 Jan 17. — View Citation

Kemeny ME, Foltz C, Cavanagh JF, Cullen M, Giese-Davis J, Jennings P, Rosenberg EL, Gillath O, Shaver PR, Wallace BA, Ekman P. Contemplative/emotion training reduces negative emotional behavior and promotes prosocial responses. Emotion. 2012 Apr;12(2):338-50. doi: 10.1037/a0026118. Epub 2011 Dec 12. — View Citation

Kemp AH, Brunoni AR, Santos IS, Nunes MA, Dantas EM, Carvalho de Figueiredo R, Pereira AC, Ribeiro AL, Mill JG, Andreao RV, Thayer JF, Bensenor IM, Lotufo PA. Effects of depression, anxiety, comorbidity, and antidepressants on resting-state heart rate and its variability: an ELSA-Brasil cohort baseline study. Am J Psychiatry. 2014 Dec 1;171(12):1328-34. doi: 10.1176/appi.ajp.2014.13121605. Epub 2014 Oct 31. — View Citation

Koenig HG, Büssing A .The Duke University Religion Index (DUREL): A Five-Item Measure for Use in Epidemological Studies. Religions. 2010, 1(1): 78-85.

Koenig HG, McCullough ME, Larson DB. Handbook of Religion and Health. Oxford University Press. 2001.

Kreplin U, Farias M, Brazil IA. The limited prosocial effects of meditation: A systematic review and meta-analysis. Sci Rep. 2018 Feb 5;8(1):2403. doi: 10.1038/s41598-018-20299-z. — View Citation

Kuczok M. The Interplay of Metaphor and Metonymy in Christian Symbols. Metaphor and Symbol. 2020; 35(4): 236-249.

Kuggle S. The Brilliance of Hearts. Islam in South Asia in Practice. Princeton University Press. 2010.

Laird M. Into the Silent Land: A Guide to the Christian Practice of Contemplation. Oxford University Press. 2006.

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u. — View Citation

Lovibond SH, Lovibond PF. Manual for the Depression Anxiety Stress Scales. Psychology Foundation: Sydney, Australia. 1995.

Marchant J. Cure: A Journey into the Science of Mind Over Body. Two Ravens Press. 2016.

May RW, Cooper AN, Fincham FD. Prayer in Marriage to Improve Wellness: Relationship Quality and Cardiovascular Functioning. J Relig Health. 2020 Dec;59(6):2990-3003. doi: 10.1007/s10943-019-00829-3. — View Citation

Morgan D. The Sacred Heart of Jesus: The Visual Evolution of a Devotion. Amsterdam University Press. 2008.

Murphy RO, Ackermann KA, Handgraaf M. Measuring social value orientation. Judgment and Decision Making. 2011; 6(8): 771-781.

Oman D, Hedberg J, Thoresen CE. Passage meditation reduces perceived stress in health professionals: a randomized, controlled trial. J Consult Clin Psychol. 2006 Aug;74(4):714-9. doi: 10.1037/0022-006X.74.4.714. — View Citation

Oman D. Studying the effects of meditation: The first fifty years. The Oxford Handbook of Meditation. Oxford University Press. 2021.

Pargament KI. The Psychology of Religion and Coping: Theory, Research, and Practice. New York: Guilford Press. 1997.

Parrott, J. How to be a Mindful Muslim: An Exercise in Islamic Meditation. Yaqeen Institute for Islamic Research. 2017.

Porcelli AJ. An alternative to the traditional cold pressor test: the cold pressor arm wrap. J Vis Exp. 2014 Jan 16;(83):e50849. doi: 10.3791/50849. — View Citation

Saab PG, Llabre MM, Hurwitz BE, Schneiderman N, Wohlgemuth W, Durel LA, Massie C, Nagel J. The cold pressor test: vascular and myocardial response patterns and their stability. Psychophysiology. 1993 Jul;30(4):366-73. doi: 10.1111/j.1469-8986.1993.tb02058.x. — View Citation

Sanfey AG. Social decision-making: insights from game theory and neuroscience. Science. 2007 Oct 26;318(5850):598-602. doi: 10.1126/science.1142996. — View Citation

Sedlmeier P, Eberth J, Schwarz M, Zimmermann D, Haarig F, Jaeger S, Kunze S. The psychological effects of meditation: a meta-analysis. Psychol Bull. 2012 Nov;138(6):1139-71. doi: 10.1037/a0028168. Epub 2012 May 14. — View Citation

Shalev AY, Sahar T, Freedman S, Peri T, Glick N, Brandes D, Orr SP, Pitman RK. A prospective study of heart rate response following trauma and the subsequent development of posttraumatic stress disorder. Arch Gen Psychiatry. 1998 Jun;55(6):553-9. doi: 10.1001/archpsyc.55.6.553. — View Citation

Shapiro D, Walsh R. Meditation: Classic and contemporary perspectives. Aldine. 1984.

Skwara A, King B, Saron C. Studies of training compassion: What have we learned; what remains unknown? Oxford Handbook of Compassion Science. Oxford University Press. 2017.

Spearing AC. The Cloud of Unknowing and Other Works (Penguin Classics). Penguin Books Ltd. 2001.

Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. CA: Consulting Psychologists Press. 1983.

Tang YY, Bruya B. Mechanisms of Mind-Body Interaction and Optimal Performance. Front Psychol. 2017 May 9;8:647. doi: 10.3389/fpsyg.2017.00647. eCollection 2017. No abstract available. — View Citation

Tang YY, Ma Y, Wang J, Fan Y, Feng S, Lu Q, Yu Q, Sui D, Rothbart MK, Fan M, Posner MI. Short-term meditation training improves attention and self-regulation. Proc Natl Acad Sci U S A. 2007 Oct 23;104(43):17152-6. doi: 10.1073/pnas.0707678104. Epub 2007 Oct 11. — View Citation

Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28. — View Citation

Underwood LG. The Daily Spiritual Experience Scale: Overview and Results. Religions, 2011; 2(1): 29-50.

Van Cappellen P, Toth-Gauthier M, Saroglou V, Fredrickson BL. Religion and Well-Being: The Mediating Role of Positive Emotions. Journal of Happiness Studies. 2014; 17(2): 485-505.

Van Dam NT, van Vugt MK, Vago DR, Schmalzl L, Saron CD, Olendzki A, Meissner T, Lazar SW, Kerr CE, Gorchov J, Fox KCR, Field BA, Britton WB, Brefczynski-Lewis JA, Meyer DE. Mind the Hype: A Critical Evaluation and Prescriptive Agenda for Research on Mindfulness and Meditation. Perspect Psychol Sci. 2018 Jan;13(1):36-61. doi: 10.1177/1745691617709589. Epub 2017 Oct 10. Erratum In: Perspect Psychol Sci. 2020 Sep;15(5):1289-1290. — View Citation

vanOyen Witvliet C, Ludwig TE, Vander Laan KL. Granting forgiveness or harboring grudges: implications for emotion, physiology, and health. Psychol Sci. 2001 Mar;12(2):117-23. doi: 10.1111/1467-9280.00320. — View Citation

Visted E, Vøllestad J, Nielsen MB, Nielsen GH. The Impact of Group-Based Mindfulness Training on Self-Reported Mindfulness: a Systematic Review and Meta-analysis. Mindfulness. 2014; 6(3): 501-522.

Wachholtz AB, Malone CD, Pargament KI. Effect of Different Meditation Types on Migraine Headache Medication Use. Behav Med. 2017 Jan-Mar;43(1):1-8. doi: 10.1080/08964289.2015.1024601. Epub 2015 Apr 11. — View Citation

Wachholtz AB, Pargament KI. Is spirituality a critical ingredient of meditation? Comparing the effects of spiritual meditation, secular meditation, and relaxation on spiritual, psychological, cardiac, and pain outcomes. J Behav Med. 2005 Aug;28(4):369-84. doi: 10.1007/s10865-005-9008-5. — View Citation

Ware K. How do we enter the heart? Paths to the Heart: Sufism and the Christian East. Bloomington, Indiana: World Wisdom. 2002; 2-23.

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. — View Citation

Weaver B, Bedard M, McAuliffe J. Evaluation of a 10-minute version of the Attention Network Test. Clin Neuropsychol. 2013;27(8):1281-99. doi: 10.1080/13854046.2013.851741. Epub 2013 Nov 9. — View Citation

Wiech K, Farias M, Kahane G, Shackel N, Tiede W, Tracey I. An fMRI study measuring analgesia enhanced by religion as a belief system. Pain. 2008 Oct 15;139(2):467-476. doi: 10.1016/j.pain.2008.07.030. Epub 2008 Sep 5. — View Citation

Williams JM, Crane C, Barnhofer T, Brennan K, Duggan DS, Fennell MJ, Hackmann A, Krusche A, Muse K, Von Rohr IR, Shah D, Crane RS, Eames C, Jones M, Radford S, Silverton S, Sun Y, Weatherley-Jones E, Whitaker CJ, Russell D, Russell IT. Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial. J Consult Clin Psychol. 2014 Apr;82(2):275-86. doi: 10.1037/a0035036. Epub 2013 Dec 2. — View Citation

Yazaki S. Islamic Mysticism and Abu Talib Al-Makki: The Role of the Heart. Routledge. 2013.

* Note: There are 78 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Spirituality: Change in Spiritual Experiences 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)
Other Spirituality: Change in Closeness to God 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 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)
Other Spirituality: Religiosity 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)
Other Credibility/Expectancy of the meditation practices 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 Pre-intervention (collected up to 1 week before the intervention)
Other Closeness to the offender 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 Pre-intervention (collected up to 3 hours before the intervention)
Other Demographics: Age Self-report assessment Pre-intervention (collected up to 1 week before the intervention)
Other Demographics: Ethnicity Self-report assessment Pre-intervention (collected up to 1 week before the intervention)
Other Demographics: Gender Identity Self-report assessment Pre-intervention (collected up to 1 week before the intervention)
Other Demographics: Biological Sex Self-report assessment Pre-intervention (collected up to 1 week before the intervention)
Other Socioeconomic Status: Employment status Self-report assessment Pre-intervention (collected up to 1 week before the intervention)
Other Socioeconomic Status: Education level Self-report assessment Pre-intervention (collected up to 1 week before the intervention)
Other Socioeconomic Status: Annual household income Self-report assessment Pre-intervention (collected up to 1 week before the intervention)
Other Potential adverse events in the meditative practices 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 Post-intervention (collected up to two weeks after the 8-week intervention)
Other Experiences of the App-based exercises Self-report assessment about participant's experiences with the App-based exercises 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)
Other Frequency of the contemplative or mindfulness practices after the end of the intervention Self-report assessment about frequency of participant's practices after the end of the 8-week intervention at 3-month follow-up (collected up to 2 weeks following 3 months after the end of the intervention)
Other Qualitative assessment: Themes emerging from participant's meditation diary Key themes that emerge from participants' diaries for their reflection on their experiences of the daily meditative practices Throughout the 8 weeks intervention
Other Qualitative assessment: Themes emerging from participant's daily meditative experiences Key themes that emerge from participants' daily meditative experiences assessed within the App Throughout the 8 weeks intervention
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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 Physiology: Change in Pain Tolerance The duration (in seconds) that a participant endures painful stimulation assessed during an endurance task Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Secondary Physiology: Change in Pain Intensity 0-10 Numerical Rating Scale Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Secondary Physiology: Change in Stress Reactivity (1) Heart rate Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Secondary Physiology: Change in Stress Reactivity (2) Heart rate variability Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Secondary Physiology: Change in psychophysiological reactivity associated with forgiveness (1) Heart rate assessed during a forgiveness task. Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Secondary Physiology: Change in psychophysiological reactivity associated with forgiveness (2) Heart rate variability assessed during a forgiveness task Pre-intervention (collected up to 3 hours before the intervention), and post-intervention (collected up to two weeks after the 8-week intervention)
Secondary Attention: Change in Alerting Attention network 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)
Secondary Attention: Change in Orienting Attention network 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)
Secondary Attention: Change in Executive Attention network 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)
Secondary 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 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)
Secondary 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 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)
Secondary 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 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)
Secondary 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 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)
Secondary 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 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)
Secondary 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 Throughout the 8 weeks intervention
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A