NCT05695586: MSC-Health

Effects of the Mindful Self-Compassion (MSC) Program

Completed NA Last updated 11 December 2024

What this trial tests

NA trial testing Mindful Self-Compassion (MSC) training in Self-compassion in 170 participants. Completed in 19 February 2024.

Timeline

14 November 2022

Primary endpoint
19 February 2024

19 February 2024

Quick facts

Lead sponsor	Universidad Pontificia de Salamanca
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	170
Start date	14 November 2022
Primary completion	19 February 2024
Estimated completion	19 February 2024
Sites	1 location across Spain

Drugs / interventions tested

• Mindful Self-Compassion (MSC) training
• Mindfulness Based Stress Reduction (MBSR) training

Conditions studied

• Self-compassion — all drugs for Self-compassion →
• Mindfulness — all drugs for Mindfulness →
• Mental Health — all drugs for Mental Health →
• Well-being — all drugs for Well-being →

Sponsor

Universidad Pontificia de Salamanca

Who can join

Adults 18 to 65, any sex, with Self-compassion or Mindfulness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Long-term effectiveness of the Mindful Self-Compassion programme compared to a Mindfulness-Based Stress Reduction intervention: a quasi-randomised controlled trial involving regular mindfulness practice for 1 year.
   Crego A, Yela JR, Gómez-Martínez MÁ, Sánchez-Zaballos E, et al · · 2025 · cited 2× · PMID 40357479 · DOI 10.3389/fpsyg.2025.1597264
2. Measuring psychological flexibility to promote wellbeing: validation of the Spanish Psy-Flex in a healthy sample.
   Crego A, Yela-Gómez S, Yela JR, Ruiz FJ, et al · · 2026 · PMID 42137107 · DOI 10.3389/fpsyg.2026.1808313