Clinical trial NCT05695586: Effects of the Mindful Self-Compassion (MSC) Program
Official title: Effects of the Mindful Self-Compassion (MSC) Program on Psychological Well-being, Health, and Inflammatory Response: An ex Post Facto Study and a Longitudinal RCT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-compassion
Mindfulness
Mental Health
Well-being
Inflammatory Response
Cardiovascular Health
Keywords: Self-compassion
Mindfulness
Mindful Self-Compassion (MSC)
Mindfulness Based Stress Reduction (MBSR)
Mental health
Well-being
Inflammatory Response
Cardiovascular Health
Lead sponsor: Universidad Pontificia de Salamanca
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
First posted: 2023-01-25
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The efficacy of the Mindfulness Based Stress Reduction (MBSR) program has been widely researched. However, research on the efficacy of a standardized program, specifically focused on self-compassion skills, such as the Mindful Self-Compassion (MSC) program remains scarce. Moreover, the use of long-term follow-ups and the analysis of regular practice of mindfulness and self-compassion over time to identify possible changes in inflammatory activity and in biomarkers associated with diseases has been even less analysed and represent a gap in this area. In this context, a main hypothesis is proposed: MSC training and the subsequent regular practice will contribute to improve mental health, self-reported health status, psychological wellbeing and health-related biomarkers. This research uses a RCT design to analyse our main hypothesis. Our RCT design includes three conditions, i.e. MSC group compared to a well-established protocol MBSR training group and to a waitlist control group (CG), and four moments of measure, i.e. pre- and post-training, 6-month, and 12-month follow-ups. Participants in the experimental conditions will receive, respectively, the MSC and MBSR 8-week trainings and afterwards they will go on with weekly MSC/MBSR guided practices over a 12-month period. In addition to an analysis of the relative efficacy of MSC compared to MBSR and CG, we will also study the mechanisms involved in the efficacy of MSC training.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals
* Not having previous experience in mindfulness and/or self-compassion practices.

Exclusion Criteria:

* Having suffered or currently suffer from a psychiatric disorder, being in psychiatric or psychological treatment,
* Suffering from a severe medical disorder that could affect inflammatory response, as well as systemic inflammation (cancer, AIDS or any other chronic disease that occurs with inflammation, including COVID-19).
* Having received psychotropic medication within 2 weeks prior to blood extractions (as it interferes with the immune and neuroendocrine systems), or having signs of acute infection on the day of the blood extraction.
* The influence of variables that may affect some of the biomarkers (e.g., time of sample collection, seasonality, BMI, diet, omega-3, vitamin D, nutritional supplements, etc.) will also be taken into account.

Primary outcomes:
measure: Change in perceived general health status from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in Subjective Happiness Scale scores (Lyubomirsky & Lepper, 1999.; Extremera, 2013) from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in Satisfaction with Life Scale scores (Diener et al., 1985; Atienza et al., 2003) from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in Self-Compassion Scale (SCS) scores (Neff, 2003; García-Campayo et al., 2014) from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in Mindful Attention Awareness Scale (MAAS) scores (Brown & Ryan, 2003; Soler et al. 2012) from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in Meaning in Life Questionnaire (MLQ) scores (Steger et al., 2006) from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in Acceptance and Action Questionnaire-II (AAQ-II) scores (Bond et al., 2011;Ruiz et al. 2013) from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in the Activation Subscale of the Behavioural Activation for Depression Scale (BADS) scores (Kanter et al., 2007; Barraca et al., 2011) from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in Positive and Negative Affect Schedule (PANAS) scores (Watson, Clark & Tellegen, 1988; López-Gómez et al., 2015) from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in Cognitive Fusion Questionnaire (CFQ) scores (Gillanders et al.,2014; Romero-Moreno et al., 2014) from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in psychological flexibility scores from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in depression and anxiety scores from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in mental health self-informed status from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in Perceived Stress Scale (PSS) scores (Cohen et al. 1983; Remor & Carrobles, 2001) from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in burnout scores from pre-intervention at 8-week, 6-month and 12-month.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in basal glucose levels
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in cholesterol levels
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in triglyceride levels
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in High-density lipoprotein (HDL)-Cholesterol levels
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in Low-density lipoprotein (LDL)-Cholesterol levels.
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change ultrasensitive C-Reactive Protein (CRP) levels
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in the lipemia index
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in the jaundice index
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in the hemolysis index
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in the levels of aspartate aminotransferase (GOT/AST)
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in lactate dehydrogenase (LDH) levels
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
measure: Change in Creatin Kinase (CK) levels
timeFrame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Universidad Pontificia de Salamanca
state: Salamanca (Castilla Y León)
Study officials:
affiliation: Universidad Pontificia de Salamanca
name: José Ramón Yela, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Pontificia de Salamanca
name: Antonio Crego, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Germer CK, Neff KD. Self-compassion in clinical practice. J Clin Psychol. 2013 Aug;69(8):856-67. doi: 10.1002/jclp.22021. Epub 2013 Jun 17.
citation: Germer, C. & Neff, K. (2013b). The Mindful Self-Compassion training program. In T. Singer & M. Bolz (Eds.) Compassion: Bridging theory and practice: A multimedia book (pp. 365-396). Leipzig, Germany: Max-Planck Institute. Retrieved from: http://www.compassion-training.org/
citation: Germer, C., & Neff, K. (2019). Teaching the mindful self-compassion program: A guide for professionals. New York: Guilford Publications.
citation: Neff, K., & Germer, C. (2017). Self-Compassion and psychological well-being. In Seppälä, E. M., Simon-Thomas, E., Brown, S. L., Worline, M. C., Cameron, C. D., & Doty, J. R. (Eds.). (2017). The Oxford Handbook of Compassion Science (pp. 371-386). Oxford: Oxford University Press.
citation: Neff, K. D., & Germer, C. K. (2018). The Mindful Self-Compassion workbook: A proven way to accept yourself, find inner strength, and thrive. New York: The Guilford Press.
citation: Yela, J.R., Gómez Martínez, Mª. A., Crego, A., & Jiménez, L. (2020a). Effects of the Mindful Self-Compassion Programme on Clinical and Health Psychology Trainees' well-being: a Pilot Study. Clinical Psychologist, 24, 41-54. https://doi.org/10.1111/cp.12204
citation: Yela JR, Crego A, Gomez-Martinez MA, Jimenez L. Self-compassion, meaning in life, and experiential avoidance explain the relationship between meditation and positive mental health outcomes. J Clin Psychol. 2020 Sep;76(9):1631-1652. doi: 10.1002/jclp.22932. Epub 2020 Jan 24.
citation: Yela JR, Crego A, Buz J, Sanchez-Zaballos E, Gomez-Martinez MA. Reductions in experiential avoidance explain changes in anxiety, depression and well-being after a mindfulness and self-compassion (MSC) training. Psychol Psychother. 2022 Jun;95(2):402-422. doi: 10.1111/papt.12375. Epub 2021 Dec 13.
citation: Jiménez-Gómez, L., Yela, J.R., Crego, A. et al. Effectiveness of the Mindfulness-Based Stress Reduction (MBSR) vs. the Mindful Self-Compassion (MSC) Programs in Clinical and Health Psychologist Trainees. Mindfulness 13, 584-599 (2022). https://doi.org/10.1007/s12671-021-01814-2
citation: Melero, A. R., Yela, J. R., Crego, A., & Cortés-Rodríguez, M. (2020). Effectiveness of a Mindfulness-Based Cognitive Therapy Group Intervention in Reducing Gambling-Related Craving. Journal of Evidence-Based Psychotherapies, 20(1), 107-134.
citation: Stahl, B., & Goldstein, E. (2019). A mindfulness-based stress reduction workbook. New Harbinger publications.
citation: Goldstein, E., & Stahl, B. (2015). MBSR every day: Daily practices from the heart of mindfulness-based stress reduction. New Harbinger Publications.