Clinical trial NCT05516355: Psychological and Neurobiological Impact of a Retreat Based on Mindfulness and Compassion for Stress Reduction.
Official title: Psychological and Neurobiological Impact of a Retreat Based on Mindfulness and Compassion for Stress Reduction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Compassion
Psychophysiologic Reaction
Psychological Distress
Emotion Regulation
Stress
Keywords: MBSR
CCT
Mindfulness
Compassion
Epigenetics
Stress
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 49
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study is aimed at comparing the differential effects of two widely used standardized meditation programs: Mindfulness-Based Stress Reduction (MBSR) and Compassion Cultivation Training (CCT) delivered in a retreat format with a cross-over design in a general population sample of healthy adults.

Detailed description: The main objective of the study is to evaluate the effects of two mindfulness-based intensive interventions: Mindfulness-Based Stress Reduction (MBSR) training or Compassion Cultivation Training (CCT), on psychological, physiological and epigenetic changes in a population of health volunteer adults. During a 7-day retreat participants will be randomised to two study arms: group 1 and 2, beginning either with a 3-day MBSR training or a 3-day CCT training. On the 4th day they will cross-over to the opposite intervention.

To address this goal, the effects will be measured by self-report questionnaires belonging to different domains (mindfulness, compassion, well-being, psychological distress, and psychological functioning), psychophysiological measures (EEG resting state, Diurnal cortisol slope, EKG and respiration patterns), epigenetic changes (DNA methylation biomarkers) and an objective stress task (Arithmetic Stress Test). Psychobiological outcome measures will be collected from both groups on day 1 (pre-intervention), on day 4 (post intervention and before beginning of the second intervention). The third assessment will be conducted on day 7 for both groups (post-second intervention). A 6-month follow-up assessment will be carried in both groups only for psychological questionnaires.

Data analysis will include change scores in psychological outcome measures as well as DNA methylation (by EPIC arrays) and gene expression (RNA-seq) measures.

Eligibility criteria: Inclusion Criteria:

* Healthy adult participants.

Exclusion Criteria:

* Current or past self-reported diagnosable serious or disabling mental disorder (in particular, PTSD, major depression, psychotic disorders, and/or Use of alcohol or drugs disorders).
* Presenting current health conditions that might affect the immune system (i.e. autoimmune disease, chronic severe infections, HIV, cancer) or past history of the same (less than 5 years from total recovery).
* Presenting current habits that might affect the immune system (i.e. smoking, alcoholism, substance abuse).
* Being under medical treatment that might affect the immune system response and inflammatory processes (i.e. corticoids).
* Travelling from a different time zone/long-travel times that might affect the immune system.

Primary outcomes:
measure: Epigenetic changes
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)
measure: Change in Psychological distress
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
measure: Change in Stress Reactivity
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)
measure: Change in Resting State Activity
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)
measure: Change in Cortisol activity
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program
measure: Change in Emotion regulation in retrieving autobiographical negative memories
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)
Secondary outcomes:
measure: Change in Mindfulness State
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
measure: Change in Mindfulness - Adverse Effects
timeFrame: Mid-intervention (T2: Day 4 in the 7-day program), post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
measure: Change in Compassion - State self-compassion
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
measure: Change in Compassion - Fear of Compassion
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
measure: Change in current mood
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
measure: Change in Psychological well-being - Satisfaction with life
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
measure: Change in Somatic Symptoms
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
measure: Change in Emotion Regulation
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
measure: Change in Anxiety state and trait
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
measure: Change in Sleep difficulties
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
measure: Program satisfaction
timeFrame: Mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)
measure: Daily assessments of psychological functioning
timeFrame: Daily, at the end of the day, during the 7-day retreat
measure: Change in Affect
timeFrame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)
Other outcomes:
measure: EKG activity
timeFrame: ime Frame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)
measure: Respiratory patterns
timeFrame: ime Frame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid - Faculty of Psychology
Study officials:
affiliation: Universidad Complutense de Madrid
name: Carmelo Vazquez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alvarez-Lopez MJ, Conklin QA, Cosin-Tomas M, Shields GS, King BG, Zanesco AP, Kaliman P, Saron CD. Changes in the expression of inflammatory and epigenetic-modulatory genes after an intensive meditation retreat. Compr Psychoneuroendocrinol. 2022 Jun 23;11:100152. doi: 10.1016/j.cpnec.2022.100152. eCollection 2022 Aug.
citation: Bishop, S. R., Lau, M., Shapiro, S., Carlson, L., Anderson, N. D., Carmody, J., Segal, Z. v., Abbey, S., Speca, M., Velting, D., & Devins, G. (2004). Mindfulness: A proposed operational definition. Clinical Psychology: Science and Practice, 11(3), 230-241. https://doi.org/10.1093/clipsy/bph077
citation: Chambers, R., Lo, B. C. Y., & Allen, N. B. (2008). The impact of intensive mindfulness training on attentional control, cognitive style, and affect. Cognitive therapy and research, 32(3), 303-322. https://doi.org/10.1007/s10608-007-9119-0
citation: Chiesa A, Calati R, Serretti A. Does mindfulness training improve cognitive abilities? A systematic review of neuropsychological findings. Clin Psychol Rev. 2011 Apr;31(3):449-64. doi: 10.1016/j.cpr.2010.11.003. Epub 2010 Dec 1.
citation: Cohen, J. N., Jensen, D., Stange, J. P., Neuburger, M., & Heimberg, R. G. (2017). The immediate and long-term effects of an intensive meditation retreat. Mindfulness, 8(4), 1064-1077.
citation: Davidson RJ, Kaszniak AW. Conceptual and methodological issues in research on mindfulness and meditation. Am Psychol. 2015 Oct;70(7):581-92. doi: 10.1037/a0039512.
citation: Fransquet PD, Wrigglesworth J, Woods RL, Ernst ME, Ryan J. The epigenetic clock as a predictor of disease and mortality risk: a systematic review and meta-analysis. Clin Epigenetics. 2019 Apr 11;11(1):62. doi: 10.1186/s13148-019-0656-7.
citation: Galante J, Friedrich C, Dawson AF, Modrego-Alarcon M, Gebbing P, Delgado-Suarez I, Gupta R, Dean L, Dalgleish T, White IR, Jones PB. Mindfulness-based programmes for mental health promotion in adults in nonclinical settings: A systematic review and meta-analysis of randomised controlled trials. PLoS Med. 2021 Jan 11;18(1):e1003481. doi: 10.1371/journal.pmed.1003481. eCollection 2021 Jan.
citation: Garland, E. L., Kiken, L. G., Faurot, K., Palsson, O., & Gaylord, S. A. (2017). Upward spirals of mindfulness and reappraisal: Testing the mindfulness-to-meaning theory with autoregressive latent trajectory modeling. Cognitive Therapy and Research, 41(3), 381-392. https://doi.org/10.1007/s10608-016-9768-y
citation: Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Wampold BE, Kearney DJ, Simpson TL. Mindfulness-based interventions for psychiatric disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2018 Feb;59:52-60. doi: 10.1016/j.cpr.2017.10.011. Epub 2017 Nov 8.
citation: Hirshberg MJ, Goldberg SB, Rosenkranz M, Davidson RJ. Prevalence of harm in mindfulness-based stress reduction. Psychol Med. 2022 Apr;52(6):1080-1088. doi: 10.1017/S0033291720002834. Epub 2020 Aug 18.
citation: Kaliman P. Epigenetics and meditation. Curr Opin Psychol. 2019 Aug;28:76-80. doi: 10.1016/j.copsyc.2018.11.010. Epub 2018 Nov 22.
citation: Kaliman P, Alvarez-Lopez MJ, Cosin-Tomas M, Rosenkranz MA, Lutz A, Davidson RJ. Rapid changes in histone deacetylases and inflammatory gene expression in expert meditators. Psychoneuroendocrinology. 2014 Feb;40:96-107. doi: 10.1016/j.psyneuen.2013.11.004. Epub 2013 Nov 15.
citation: Khoury B, Knauper B, Schlosser M, Carriere K, Chiesa A. Effectiveness of traditional meditation retreats: A systematic review and meta-analysis. J Psychosom Res. 2017 Jan;92:16-25. doi: 10.1016/j.jpsychores.2016.11.006. Epub 2016 Nov 18.
citation: Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta-analysis. J Psychosom Res. 2015 Jun;78(6):519-28. doi: 10.1016/j.jpsychores.2015.03.009. Epub 2015 Mar 20.
citation: Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.
citation: Kring, A. M., & Sloan, D. M. (2009). Mindfulness and emotion regulation. Emotion regulation and psychopathology: A transdiagnostic approach to etiology and treatment: Guilford Press.
citation: Lindsay EK, Young S, Smyth JM, Brown KW, Creswell JD. Acceptance lowers stress reactivity: Dismantling mindfulness training in a randomized controlled trial. Psychoneuroendocrinology. 2018 Jan;87:63-73. doi: 10.1016/j.psyneuen.2017.09.015. Epub 2017 Oct 8.
citation: Lomas T, Ivtzan I, Fu CH. A systematic review of the neurophysiology of mindfulness on EEG oscillations. Neurosci Biobehav Rev. 2015 Oct;57:401-10. doi: 10.1016/j.neubiorev.2015.09.018. Epub 2015 Oct 9.
citation: Lutz J, Herwig U, Opialla S, Hittmeyer A, Jancke L, Rufer M, Grosse Holtforth M, Bruhl AB. Mindfulness and emotion regulation--an fMRI study. Soc Cogn Affect Neurosci. 2014 Jun;9(6):776-85. doi: 10.1093/scan/nst043. Epub 2013 Apr 5.
citation: Magan D, Yadav RK. Psychoneuroimmunology of Meditation. Ann Neurosci. 2022 Apr;29(2-3):170-176. doi: 10.1177/09727531221109117. Epub 2022 Jul 11.
citation: Malinowski P. Neural mechanisms of attentional control in mindfulness meditation. Front Neurosci. 2013 Feb 4;7:8. doi: 10.3389/fnins.2013.00008. eCollection 2013.
citation: Morton, M. L., Helminen, E. C., & Felver, J. C. (2020). A Systematic Review of Mindfulness Interventions on Psychophysiological Responses to Acute Stress. Mindfulness, 11(9), 2039-2054. https://doi.org/10.1007/s12671-020-01386-7
citation: Ostafin, B. D., Robinson, M. D., & Meier, B. P. (Eds.). (2015). Handbook of mindfulness and self-regulation. New York: Springer.
citation: Roca P, Vazquez C, Diez G, Brito-Pons G, McNally RJ. Not all types of meditation are the same: Mediators of change in mindfulness and compassion meditation interventions. J Affect Disord. 2021 Mar 15;283:354-362. doi: 10.1016/j.jad.2021.01.070. Epub 2021 Feb 2.
citation: Tang YY, Holzel BK, Posner MI. The neuroscience of mindfulness meditation. Nat Rev Neurosci. 2015 Apr;16(4):213-25. doi: 10.1038/nrn3916. Epub 2015 Mar 18.
citation: Venditti S, Verdone L, Reale A, Vetriani V, Caserta M, Zampieri M. Molecules of Silence: Effects of Meditation on Gene Expression and Epigenetics. Front Psychol. 2020 Aug 11;11:1767. doi: 10.3389/fpsyg.2020.01767. eCollection 2020.
citation: Wielgosz J, Goldberg SB, Kral TRA, Dunne JD, Davidson RJ. Mindfulness Meditation and Psychopathology. Annu Rev Clin Psychol. 2019 May 7;15:285-316. doi: 10.1146/annurev-clinpsy-021815-093423. Epub 2018 Dec 10.