Effects of the Mindful Self-Compassion (MSC) Program (MSC-Health)

Universidad Pontificia de Salamanca

Status: Completed

Conditions: Well-being; Cardiovascular Health; Inflammatory Response; Mindfulness; Self-compassion; Mental Health

Treatments: Behavioral: Mindful Self-Compassion (MSC) training; Behavioral: Mindfulness Based Stress Reduction (MBSR) training

Study type: Interventional

Funder types: Other

Identifiers

NCT05695586

PID2021-125918OB-I00

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 3 patient groups

Mindful Self-Compassion (MSC) training

Experimental group

Description:

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.

Treatment:

Behavioral: Mindful Self-Compassion (MSC) training

Mindfulness Based Stress Reduction (MBSR) training

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Based Stress Reduction (MBSR) training

Control group

No Intervention group

Description:

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.