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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05516355
Other study ID # ESCORIAL RETREAT 2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date August 30, 2022

Study information

Verified date November 2022
Source Universidad Complutense de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date August 30, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Mindfulness-Based Stress Reduction
The MBSR is an 8-week standardized program (Kabat-Zinn,1990). During the retreat, participants will receive intensive training during 3 days (from 4:00pm to 9pm the first day and from 7 am to 10 pm including breaks, the second and third days), including focused attention on the breath, open monitoring of awareness in body-scanning, prosocial meditation (i.e. loving kindness and compassion) and gentle yoga. Training is delivered by certified instructors by the University of Massachusetts Centre for Mindfulness (https://www.umassmed.edu/cfm/).
Compassion Cultivation Training
The CCT is an 8-week standardized program (Jinpa, 2010; Jazaieri et al. 2013, 2014) consisting of daily formal and informal practices. Training will be conducted during 3 days of the retreat (same schedule as the MBSR training). The CCT consists of six sequential steps: 1) Settling the mind and learn how to focus it; 2) Loving kindness and compassion for a loved one practice; 3) Loving kindness and compassion for oneself practice; 4) compassion toward others, embracing shared common humanity and developing appreciation of others; 5) compassion toward others including all beings; and 6) active compassion practices (Tonglen) which involve explicit evocation of the altruistic wish to do something about others' suffering. CCT program is delivered by certified instructors by the University of Stanford Centre for Compassion and Altruism Research and Education (http://ccare.stanford.edu/).

Locations

Country Name City State
Spain Universidad Complutense de Madrid - Faculty of Psychology Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (28)

Álvarez-López MJ, Conklin QA, Cosín-Tomás 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. — View 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

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

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. Review. — View 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.

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. Review. — View 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. Review. — View Citation

Galante J, Friedrich C, Dawson AF, Modrego-Alarcón M, Gebbing P, Delgado-Suárez 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. — View 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

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. — View Citation

Hirshberg MJ, Goldberg SB, Rosenkranz M, Davidson RJ. Prevalence of harm in mindfulness-based stress reduction. Psychol Med. 2020 Aug 18:1-9. doi: 10.1017/S0033291720002834. [Epub ahead of print] — View Citation

Kaliman P, Alvarez-López MJ, Cosín-Tomás 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. — View 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. Review. — View Citation

Khoury B, Knäuper B, Schlosser M, Carrière 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. Review. — View 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. Review. — View 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. — View 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.

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. — View 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. Review. — View Citation

Lutz J, Herwig U, Opialla S, Hittmeyer A, Jäncke L, Rufer M, Grosse Holtforth M, Brühl 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. — View Citation

Magan, D., & Yadav, R. K. (2022). Psychoneuroimmunology of Meditation. Annals of Neurosciences, 09727531221109117.

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. — View 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

Ostafin, B. D., Robinson, M. D., & Meier, B. P. (Eds.). (2015). Handbook of mindfulness and self-regulation. New York: Springer.

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. — View Citation

Tang YY, Hölzel 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. Review. — View 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. Review. — View 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. Review. — View Citation

* Note: There are 28 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other EKG activity Measurement of cardiac activity during EEG sessions. EKG will be used in the preprocessing procedure to insulate electrophysiological artifacts due to heart activity. In addition, the heart signals will be assessed to obtain heart variability and heart rate indicators. 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)
Other Respiratory patterns Measurement of respiratory activity during EEG sessions. Respiratory signals will be employed in an specific analysis where the EEG data will be split in two blocks (inhalation and exhalation). 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)
Primary Epigenetic changes Blood samples: 20 ml collected in the standard tubes used in clinical haematology that contain EDTA as an anticoagulant. From this biological material, DNA and RNA will be extracted according to the standard molecular biology procedures, in order to subsequently measure DNA methylation (by EPIC arrays) and gene expression (RNA-seq), respectively. 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)
Primary Change in Psychological distress Depression Anxiety Stress Scales (DASS-21), (Lovibond and Lovibond, 1995). The DASS-21 is a 21-item scale containing 3 subscales (Anxiety, Depression and Stress), with 7 items for each subscale. Participants are asked to rate each item using 4-point Likert scale (0=Not applicable to me; 3=Very applicable to me). Higher scores correspond to higher levels of severity of anxiety, stress, and depression. 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)
Primary Change in Stress Reactivity Mathematical Stress Test: a standardized laboratory stress induction procedure (Kirshbaum et al., 1992). Individuals are asked to repeatedly subtract a given 2-digit number from a 4-digit number. Time is limited to 3 minutes and participants are told that this is a mental speed task and their performance will be evaluated. Stress levels will be evaluated with an affective adjective checklist (PANAS scales). 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)
Primary Change in Resting State Activity EEG resting state (alternating open and closed eyes). EEG resting state will be recorded with four 64-channel EEG devices with laptop and eego EEG recording software. The sampling rate will be 1000 Hz and the reference to be used will be 7Z of the equidistant layout.
The interventions will significantly change the EEG spectral profile of the resting state brain activity. We expect changes in the balance between Alpha (8-14 Hz) and Theta (4-8 Hz) frequency bands.
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)
Primary Change in Cortisol activity Cortisol samples 1.5 - 2.0 ml will be collected in SalivetteĀ® cortisol saliva sample collection tubes (Sarstedt, Germany) that contain sterile cotton plugs for sample absorption. From this biological material, levels of the principal stress corticosteroid, the hormone cortisol, will be assessed in order to subsequently measure the Diurnal Cortisol Slope and cortisol levels at awakening and bedtime.
Using saliva collection tubes, levels of the principal stress corticosteroid, the hormone cortisol, will be assessed in order to subsequently measure the Diurnal Cortisol Slope and cortisol levels at awakening and bedtime at three different moments of the retreat.
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
Primary Change in Emotion regulation in retrieving autobiographical negative memories A 10-min guided test to retrieve one personally painful memory. Affect changes will be asssed before and after the task by using a checklist of affective adjectives (PANAS). 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 Change in Mindfulness State State Mindfulness Scale (SMS) - (Tanay y Bernstein, 2013). The SMS has 21 items with a response scale from 1 (not at all) to 5 (very well) to indicate how well the statements describe their current mindfulness state. Higher scores represent higher states of current mindfulness. 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)
Secondary Change in Mindfulness - Adverse Effects Meditation-Related Adverse Effects Scale - Mindfulness-Based Program (MRAESMBP) -Britton et al. (2018). This is an 11-item scale measuring the frequency of challenging or distressful experiences during meditation practice. 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)
Secondary Change in Compassion - State self-compassion State Self-compassion Scale (SSCS), (Neff et al., 2021). It is a 6-item scale measuring compassion towards oneself using a 5-'point scale (1=Not at all true for me; 5= Very true for me). HIgher scores indicate higher levels of self-compassion. 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)
Secondary Change in Compassion - Fear of Compassion We will use the Fear of Expressing Compassion towards yourself subscale from the Fear of Compassion Scale (Gilbert et al. (2011). This is a 15-item scale to assess individuals' difficulties to feel or express self-compassion. We by using a 5-point Likert scale (0=Don't agree at all; 4=Completely agree). Higher scores indicate higher levels of fear of compassion towards oneself. 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)
Secondary Change in current mood A scale measuring current general positive and negative mood (PANAS). It includes 20 adjectives (10 positive, 10 negative) to assess current mood in a scale from 1 (Not all) to 5 (Extremely). Higher scores represent higher positive or negative mood states. We will use the sum of positive items and negative items to provide two separate overall scores. 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)
Secondary Change in Psychological well-being - Satisfaction with life Satisfaction With Life Scale (SWLS), (Diener et al., 1985). This is a 5-item scale assessing satisfaction with life. Higher scores indicate higher levels of satisfaction with life. 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)
Secondary Change in Somatic Symptoms Patient Health Questionnaire (PHQ-15), (Kroenke et al., 2002). The PHQ-15 comprises 15 somatic symptoms from the PHQ, each symptom scored from 0 ("not bothered at all") to 2 ("bothered a lot"). A sum score will be used to analyze somatic symptoms. 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)
Secondary Change in Emotion Regulation State Difficulties in Emotion Regulation (S-DERS-21), (Lavender et al., 2017). This is a 21-item scale in which participants rate their difficulties to regulate their mood in a 5-point Likert scale (1=Not alll; 5=Completely). Higher scores indicate more difficulties in emotion regulation. 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)
Secondary Change in Anxiety state and trait State-Trait Anxiety Inventory (STAI-20), (Spielberger et al., 1983) 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)
Secondary Change in Sleep difficulties DSM-5 sleep difficulties (APA, 2013). This is the single item included in the Self-rated level 1 Cross-Cutting Symptom Measure (DSM-5, APA 2013). It measures quality of sleep using a 5-point scale (0=Very good; 4= Very bad). 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)
Secondary Program satisfaction Client Satisfaction Questionnaire (CSQ-8)- Atkinson and Zwicq (1982). It measures satisfaction with the course of psychological interventions. Participants must rate their satisfaction on 8 items in 4-point scale. Higher scores indicate higher satisfaction with the program. Mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)
Secondary Daily assessments of psychological functioning Experience Sampling Methods on measures of: mindfulness, mind wandering, compassion to others, self-compassion, wellbeing, richness of life, and utility of the contents of the program that day. These are 'ad hoc' single items, taken from well-validated measures, to have a quick daily assessment of psychological functioning. Each item is assessed in a 5-point Likert scale (0=Never; 4= Always). Daily, at the end of the day, during the 7-day retreat
Secondary Change in Affect Hedonic and Arousal Affect Scale (HAAS), (Roca et al., 2021). This is a 12-item scale measuring affective states by including adjectives low or high in arousal and positive or negative in valence. Participants are asked to rate their affective experiences in a 5-point Likert scale (0=Not at all; 4= Absolutely). 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)
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