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Effects of the Mindful Self-Compassion (MSC) Program

NCT ID: NCT05695586

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2024-02-19

Brief Summary

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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.

Detailed Description

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Conditions

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Self-compassion Mindfulness Mental Health Well-being Inflammatory Response Cardiovascular Health

Keywords

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Self-compassion Mindfulness Mindful Self-Compassion (MSC) Mindfulness Based Stress Reduction (MBSR) Mental health Well-being Inflammatory Response Cardiovascular Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mindful Self-Compassion (MSC) training

Participants in the MSC group will be trained in the standard 8-week Mindfulness Self-Compassion (MSC) protocol (Germer and Neff, 2013a, b; Germer and Neff, 2019). Once participants have completed the 8-week MSC training they will enter a 12-month phase of regular supervised practice, in which they will continue to perform MSC exercises on a guided basis. Supervised practice will be provided on a weekly basis.

Group Type EXPERIMENTAL

Mindful Self-Compassion (MSC) training

Intervention Type BEHAVIORAL

8-week Mindful Self-Compassion (MSC) intervention protocol, developed by Germer and Neff (2013, 2019). After the training, participants will enter a 12-month phase of regular MSC-based supervised practice.

Mindfulness Based Stress Reduction (MBSR) training

Participants in the MBSR group will receive the standard 8-week Mindfulness-Based Stress Reduction (Stahl \& Goldstein, 2010). Once participants have completed the 8-week MBSR training they will enter a 12-month phase of regular supervised practice, in which they will continue to perform MBSR exercises on a guided basis. Supervised practice will be provided on a weekly basis.

Group Type EXPERIMENTAL

Mindfulness Based Stress Reduction (MBSR) training

Intervention Type BEHAVIORAL

8-week Mindfulness Based Stress Reduction (MBSR) intervention protocol, as developed by Stahl \& Goldstein (2010). After the training, participants will enter a 12-month phase of regular MBSR-based supervised practice.

Control group

The waitlist CG will comprise subjects with no MBSR/MSC related practice, who will not receive the MSC or MBSR training. However, subjects in the CG will be waitlisted to receive a MBSR or MSC training once the present project will be finished.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindful Self-Compassion (MSC) training

8-week Mindful Self-Compassion (MSC) intervention protocol, developed by Germer and Neff (2013, 2019). After the training, participants will enter a 12-month phase of regular MSC-based supervised practice.

Intervention Type BEHAVIORAL

Mindfulness Based Stress Reduction (MBSR) training

8-week Mindfulness Based Stress Reduction (MBSR) intervention protocol, as developed by Stahl \& Goldstein (2010). After the training, participants will enter a 12-month phase of regular MBSR-based supervised practice.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministerio de Ciencia e Innovación, Spain

OTHER_GOV

Sponsor Role collaborator

Universidad Pontificia de Salamanca

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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José Ramón Yela, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Pontificia de Salamanca

Antonio Crego, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Pontificia de Salamanca

Locations

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Universidad Pontificia de Salamanca

Salamanca, Salamanca (Castilla Y León), Spain

Site Status

Countries

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Spain

References

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Neff KD, Germer CK. A pilot study and randomized controlled trial of the mindful self-compassion program. J Clin Psychol. 2013 Jan;69(1):28-44. doi: 10.1002/jclp.21923. Epub 2012 Oct 15.

Reference Type BACKGROUND
PMID: 23070875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23775511 (View on PubMed)

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/

Reference Type BACKGROUND

Germer, C., & Neff, K. (2019). Teaching the mindful self-compassion program: A guide for professionals. New York: Guilford Publications.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 31981226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34904363 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Stahl, B., & Goldstein, E. (2019). A mindfulness-based stress reduction workbook. New Harbinger publications.

Reference Type BACKGROUND

Goldstein, E., & Stahl, B. (2015). MBSR every day: Daily practices from the heart of mindfulness-based stress reduction. New Harbinger Publications.

Reference Type BACKGROUND

Related Links

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https://www.upsa.es/investigacion/autocuidado

Research project website

Other Identifiers

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PID2021-125918OB-I00

Identifier Type: -

Identifier Source: org_study_id