Self-compassionMSC-HealthNCT05695586

Effects of the Mindful Self-Compassion (MSC) Program

A study testing Mindful Self-Compassion (MSC) training and Mindfulness Based Stress Reduction (MBSR) training in people with Self-compassion and Mindfulness, run by Universidad Pontificia de Salamanca at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Self-compassion, Mindfulness, Mental Health
What is being tested?: Mindful Self-Compassion (MSC) training and Mindfulness Based Stress Reduction (MBSR) training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 1 siteSpain
Study dates: 14 Nov 2022to 19 Feb 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Spain1 site

Universidad Pontificia de Salamanca
Salamanca, Salamanca (Castilla Y León), 37002

Other trials in Spain

About this study

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

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.

Conditions: Self-compassion, Mindfulness, Mental Health, Well-being, Inflammatory Response, Cardiovascular Health
Being tested: Mindful Self-Compassion (MSC) training, Mindfulness Based Stress Reduction (MBSR) training
Keywords: Self-compassion, Mindfulness, Mindful Self-Compassion (MSC), Mindfulness Based Stress Reduction (MBSR), Mental health, Well-being, Inflammatory Response, Cardiovascular Health
Medical subject headings: Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindful Self-Compassion (MSC) trainingBehavioural
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) trainingBehavioural
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.

Study groups in NCT05695586
Study group	Role	What they receive
Mindful Self-Compassion (MSC) training	Experimental	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. Receives: Behavioral: Mindful Self-Compassion (MSC) training
Mindfulness Based Stress Reduction (MBSR) training	Experimental	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. Receives: Behavioral: Mindfulness Based Stress Reduction (MBSR) training
Control group	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in perceived general health status from pre-intervention at 8-week, 6-month and 12-month.
Perceived general health status will be measured using the SF-36(v2) Health Survey general health items (Alonso et al., 2003). This subscale comprises 5 items and uses a 5-point Likert-type response format. Total scores are obtained following instructions provided by Ware et al. (1993). A higher total score (ranging from 1 to 5) indicates a better self-assessment of general health status.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in Subjective Happiness Scale scores (Lyubomirsky & Lepper, 1999.; Extremera, 2013) from pre-intervention at 8-week, 6-month and 12-month.
The Subjective Happiness Scale (SHS) is a 4-item scale used to measure the global level of perceived happiness. All items use a 7-point Likert-type scale. The total scores of subjective happiness are calculated for each participant by averaging responses to the 4 items (range 1-7), with higher scores indicating greater subjective happiness.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
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.
The SWLS consists of 5 items representing statements indicative of contentment with one's life and its conditions. The response format is a 7-point Likert-type scale, ranging from 1 = Strongly disagree to 7 = Strongly agree. The scale's total scores are calculated by averaging answers to the 5 items, with higher scores (ranging from 1 to 7) indicating greater satisfaction with life.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
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.
The Spanish version of the 26-item Self-Compassion Scale (Garcia-Campayo et al., 2014; Neff, 2003) measures the construct of self-compassion as defined by Neff (2003), that is, considering that self-compassion entails being kind toward oneself, seeing one's experiences as part of the larger human condition, and being mindfully aware of one's inner experiences, instead of being unkindly, self-critical, feeling isolated or strange, and over-identification with painful thoughts and feelings. Participants respond on a 5-points Likert-type scale, where 1 = Never and 5 = Always. Total scores are calculated by averaging each participant's responses to the items (range, 1-5), with higher scores representing greater self-compassion.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
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.
This scale comprises 15 items designed to measure the individual's general mindfulness capacity. It uses a 6-point Likert-type response format where 1 = "Almost always" and 6 = "Almost never".Total scores are obtained by averaging each participant's responses to the items, with higher scores meaning a greater mindfulness capacity.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in Meaning in Life Questionnaire (MLQ) scores (Steger et al., 2006) from pre-intervention at 8-week, 6-month and 12-month.
A 10-item questionnaire designed to measure two dimensions of meaning in life: (1) Presence of Meaning (how much respondents feel their lives have meaning), and (2) Search for Meaning (how much respondents strive to find meaning and understanding in their lives). Respondents answer each item on a 7-point Likert-type scale ranging from 1 (Absolutely True) to 7 (Absolutely Untrue). Higher scores represent experiencing higher levels of meaning in life (presence of meaning) and higher levels of search for meaning.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
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.
This measure comprises 7 items intended to measure experiential avoidance, that is, an individual's unwillingness to be exposed to and accept difficult inner experiences (e.g., thoughts, feelings, sensations) even when doing so leads to behaving in a manner that could be inconsistent with one's values and goals. Participants rate each item on a 7-point Likert-type scale, with 1 = Never true to 7 = Always true. Total scores are obtained for each participant by averaging his/her responses to the items, with higher scores representing a higher level of experiential avoidance.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
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.
The 7-item "Activation" subscale of the Behavioral Activation for Depression Scale (BADS), measures focused, goal-directed activation and completion of planned activities, e.g., "I did things even though they were hard because they fit in with my long-term goals for myself". Responses are made on a 7-point Likert-type scale from 0 = "Not at all" to 6 = "Completely". Items were averaged to obtain a total score for each participant. Higher scores reflect a higher level of behavioral activation.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
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.
This instrument consists of 10 items representing positive moods (e.g., interested, enthusiastic, inspired) and 10 items representing negative moods (e.g., irritable, upset, afraid). Participants are asked to rate the extent to which they had recently experienced each of the twenty feelings or emotions on a 5-point Likert-type scale, ranging from 1 = Very slightly or not at all to 5 = Extremely. Two separate total scores corresponding to positive and negative affect are obtained for each participant. Total scores (ranging from 1 to 5) are calculated by averaging each respondent's answers to the ten items included in the positive/negative affect scales, with higher scores indicating experiencing more positive/negative moods.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
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.
This questionnaire uses 7 items scored from 1 (never) to 7 (always) on a Likert-type scale.
Total scores are obtained for each participant by averaging his/her responses to the items, with higher scores representing a higher level of cognitive fusion.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in psychological flexibility scores from pre-intervention at 8-week, 6-month and 12-month.
Change in psychological flexibility will be measured using Psy-Flex scale (Gloster et al., 2021; Spanish translation by Ruiz Jiménez et al., 2021). This scale uses 6 items scored from 1 (never) to 5 (very often) on a Likert-type scale. Total scores are obtained for each participant, with higher scores representing a higher level of psychological flexibility.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in depression and anxiety scores from pre-intervention at 8-week, 6-month and 12-month.
Change in depression and anxiety will be measured using Hospital Anxiety and Depression Scale (HAD-S), (Zigmond \& Snaith, 1983; Terol et al., 2007). This scale comprises 14 items intended as a screening instrument to detect possible anxiety (7 items) and depression (7 items problems). Examples items are "I get sudden feelings of panic" (anxiety) and "I have lost interest in my appearance" (depression). Participants respond by selecting 1 of 4 alternatives that are scored from 0 to 3. Scores for anxiety and depression are calculated by adding the individual's responses to the items in each subscale, with higher scores indicating higher levels of anxiety and depression.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in mental health self-informed status from pre-intervention at 8-week, 6-month and 12-month.
Change in mental health self-informed status will be measured using the Mental Health Subscale of the SF-36(v2) Health Survey (Alonso et al., 2003). The Mental Health subscale of the SF-36 Health Survey (Ware et al. 1993; Spanish adaptation by Alonso et al. 1995) is used to identify possible symptoms of depression (e.g., 'Have you felt downhearted and blue?') and anxiety (e.g., 'Have you been a very nervous person?'). This subscale comprises 5 items and uses a 5-point Likert-type response format. Total scores are obtained following instructions provided by Ware et al. (1993). A higher total score (ranging from 1 to 5) indicates a better self-assessment of mental health status.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
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.
This scale uses 14 items scored from 0 (never) to 4 (very often) on a Likert-type scale.
Total scores are obtained for each participant, with higher scores representing a higher level of perceived stress.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in burnout scores from pre-intervention at 8-week, 6-month and 12-month.
A single-item measure designed by Dolan et al.(2014) will be used to measure burnout levels. Higher scores (1-5) represent higher levels of burnout.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in basal glucose levels
Basal glucose level is measured in mg/dL (milligrams per decilitre). Reference value: 60 - 100 mg/dL.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in cholesterol levels
Cholesterol level is measured in mg/dL (milligrams per decilitre). Reference value: < 200 mg/dL
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in triglyceride levels
Triglyceride levels are measured in mg/dL (milligrams per decilitre). Reference values: < 150 mg/dL After fasting 8 - 10 hours ; < 175 mg/dL Without fasting 8 - 10 hours
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in High-density lipoprotein (HDL)-Cholesterol levels
HDL-Cholesterol levels are measured in mg/dL (milligrams per decilitre). Reference value: > 40 mg/dL.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in Low-density lipoprotein (LDL)-Cholesterol levels.
LDL-Cholesterol levels are measured in mg/dL (milligrams per decilitre). Reference values: < 116 mg/dL for patients with low CV risk; < 100 mg/dL for patients with moderate CV risk; < 70 mg/dL for patients at high CV risk; < 55 mg/dL for patients with very high CV risk.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change ultrasensitive C-Reactive Protein (CRP) levels
Ultrasensitive C-Reactive Protein (CRP) levels are measured in mg/dL (milligrams per decilitre). Reference value: < 0.3 mg/dL
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in the lipemia index
Lipemia index is measured in mg/dL (milligrams per decilitre). Reference values for 5 levels indicating a progressive increase in index intensity: 0 - 50 mg/dL (No); 50 - 100 mg/dL ; 100 - 150 mg/dL; 150 - 200 mg/dL;200 - 9999999 mg/dL (Higher).
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in the jaundice index
Jaundice index is measured in mg/dL (milligrams per decilitre). Reference values for 5 levels indicating a progressive increase in index intensity: 0 - 2 mg/dL (No); 2 - 4 mg/dL; 4 - 10 mg/dL;10 - 20 mg/dL; 20 - 9999999 mg/dL (Higher).
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in the hemolysis index
Hemolysis index is measured in mg/dL (milligrams per decilitre). Reference values for 5 levels indicating a progressive increase in index intensity: < 30 mg/dL (No); 30 - 100 mg/dL; 100 - 200 mg/dL; 200 - 500 mg/dL; 500 - 9999999 mg/dL (Higher).
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in the levels of aspartate aminotransferase (GOT/AST)
The levels of aspartate aminotransferase (GOT/AST) are measured in U/L (units per liter) at 37ºC. Reference value: 8 - 43 U/L at 37 ºC
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in lactate dehydrogenase (LDH) levels
Lactate dehydrogenase (LDH) levels are measured in U/L (units per liter) at 37ºC. Reference value: 125 - 220 U/L at 37 ºC
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in Creatin Kinase (CK) levels
Creatin Kinase (CK) levels levels are measured in U/L (units per liter) at 37ºC. Reference value: < 167 U/L at 37 ºC.
Measured: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 202219 Feb 2024

First posted25 Jan 2023
Study start14 Nov 2022
Primary completion19 Feb 2024
Study completion19 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Self-compassionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05695586
Sponsor's protocol ID: PID2021-125918OB-I00
Acronym: MSC-Health
Status last verified: Dec 2024
First submitted: 21 Dec 2022
Last updated: 11 Dec 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 23070875
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.
PubMed 23775511
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/
Germer, C., & Neff, K. (2019). Teaching the mindful self-compassion program: A guide for professionals. New York: Guilford Publications.
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.
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.
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
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.
PubMed 31981226
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.
PubMed 34904363
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
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.
Stahl, B., & Goldstein, E. (2019). A mindfulness-based stress reduction workbook. New Harbinger publications.
Goldstein, E., & Stahl, B. (2015). MBSR every day: Daily practices from the heart of mindfulness-based stress reduction. New Harbinger Publications.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05695586
Acronym / sponsor ID: MSC-Health / PID2021-125918OB-I00
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Universidad Pontificia de SalamancaUniversity, hospital or other
Collaborators: Ministerio de Ciencia e Innovación, Spain
Study start: 14 Nov 2022 (actual)
Primary completion: 19 Feb 2024 (actual)
Study completion: 19 Feb 2024 (actual)
First posted: 25 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Mindful Self-Compassion (MSC) training	Experimental	Behavioral: Mindful Self-Compassion (MSC) trainingParticipants 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.
Mindfulness Based Stress Reduction (MBSR) training	Experimental	Behavioral: Mindfulness Based Stress Reduction (MBSR) trainingParticipants 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.
Control group	No intervention	–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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindful Self-Compassion (MSC) training8-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.	Behavioural	Mindful Self-Compassion (MSC) training
Mindfulness Based Stress Reduction (MBSR) training8-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.	Behavioural	Mindfulness Based Stress Reduction (MBSR) training

Primary outcome

Change in perceived general health status from pre-intervention at 8-week, 6-month and 12-month.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Perceived general health status will be measured using the SF-36(v2) Health Survey general health items (Alonso et al., 2003). This subscale comprises 5 items and uses a 5-point Likert-type response format. Total scores are obtained following instructions provided by Ware et al. (1993). A higher total score (ranging from 1 to 5) indicates a better self-assessment of general health status.
Change in Subjective Happiness Scale scores (Lyubomirsky & Lepper, 1999.; Extremera, 2013) from pre-intervention at 8-week, 6-month and 12-month.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
The Subjective Happiness Scale (SHS) is a 4-item scale used to measure the global level of perceived happiness. All items use a 7-point Likert-type scale. The total scores of subjective happiness are calculated for each participant by averaging responses to the 4 items (range 1-7), with higher scores indicating greater subjective happiness.
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.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
The SWLS consists of 5 items representing statements indicative of contentment with one's life and its conditions. The response format is a 7-point Likert-type scale, ranging from 1 = Strongly disagree to 7 = Strongly agree. The scale's total scores are calculated by averaging answers to the 5 items, with higher scores (ranging from 1 to 7) indicating greater satisfaction with life.
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.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
The Spanish version of the 26-item Self-Compassion Scale (Garcia-Campayo et al., 2014; Neff, 2003) measures the construct of self-compassion as defined by Neff (2003), that is, considering that self-compassion entails being kind toward oneself, seeing one's experiences as part of the larger human condition, and being mindfully aware of one's inner experiences, instead of being unkindly, self-critical, feeling isolated or strange, and over-identification with painful thoughts and feelings. Participants respond on a 5-points Likert-type scale, where 1 = Never and 5 = Always. Total scores are calculated by averaging each participant's responses to the items (range, 1-5), with higher scores representing greater self-compassion.
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.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
This scale comprises 15 items designed to measure the individual's general mindfulness capacity. It uses a 6-point Likert-type response format where 1 = "Almost always" and 6 = "Almost never".Total scores are obtained by averaging each participant's responses to the items, with higher scores meaning a greater mindfulness capacity.
Change in Meaning in Life Questionnaire (MLQ) scores (Steger et al., 2006) from pre-intervention at 8-week, 6-month and 12-month.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
A 10-item questionnaire designed to measure two dimensions of meaning in life: (1) Presence of Meaning (how much respondents feel their lives have meaning), and (2) Search for Meaning (how much respondents strive to find meaning and understanding in their lives). Respondents answer each item on a 7-point Likert-type scale ranging from 1 (Absolutely True) to 7 (Absolutely Untrue). Higher scores represent experiencing higher levels of meaning in life (presence of meaning) and higher levels of search for meaning.
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.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
This measure comprises 7 items intended to measure experiential avoidance, that is, an individual's unwillingness to be exposed to and accept difficult inner experiences (e.g., thoughts, feelings, sensations) even when doing so leads to behaving in a manner that could be inconsistent with one's values and goals. Participants rate each item on a 7-point Likert-type scale, with 1 = Never true to 7 = Always true. Total scores are obtained for each participant by averaging his/her responses to the items, with higher scores representing a higher level of experiential avoidance.
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.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
The 7-item "Activation" subscale of the Behavioral Activation for Depression Scale (BADS), measures focused, goal-directed activation and completion of planned activities, e.g., "I did things even though they were hard because they fit in with my long-term goals for myself". Responses are made on a 7-point Likert-type scale from 0 = "Not at all" to 6 = "Completely". Items were averaged to obtain a total score for each participant. Higher scores reflect a higher level of behavioral activation.
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.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
This instrument consists of 10 items representing positive moods (e.g., interested, enthusiastic, inspired) and 10 items representing negative moods (e.g., irritable, upset, afraid). Participants are asked to rate the extent to which they had recently experienced each of the twenty feelings or emotions on a 5-point Likert-type scale, ranging from 1 = Very slightly or not at all to 5 = Extremely. Two separate total scores corresponding to positive and negative affect are obtained for each participant. Total scores (ranging from 1 to 5) are calculated by averaging each respondent's answers to the ten items included in the positive/negative affect scales, with higher scores indicating experiencing more positive/negative moods.
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.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
This questionnaire uses 7 items scored from 1 (never) to 7 (always) on a Likert-type scale. Total scores are obtained for each participant by averaging his/her responses to the items, with higher scores representing a higher level of cognitive fusion.
Change in psychological flexibility scores from pre-intervention at 8-week, 6-month and 12-month.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in psychological flexibility will be measured using Psy-Flex scale (Gloster et al., 2021; Spanish translation by Ruiz Jiménez et al., 2021). This scale uses 6 items scored from 1 (never) to 5 (very often) on a Likert-type scale. Total scores are obtained for each participant, with higher scores representing a higher level of psychological flexibility.
Change in depression and anxiety scores from pre-intervention at 8-week, 6-month and 12-month.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in depression and anxiety will be measured using Hospital Anxiety and Depression Scale (HAD-S), (Zigmond \& Snaith, 1983; Terol et al., 2007). This scale comprises 14 items intended as a screening instrument to detect possible anxiety (7 items) and depression (7 items problems). Examples items are "I get sudden feelings of panic" (anxiety) and "I have lost interest in my appearance" (depression). Participants respond by selecting 1 of 4 alternatives that are scored from 0 to 3. Scores for anxiety and depression are calculated by adding the individual's responses to the items in each subscale, with higher scores indicating higher levels of anxiety and depression.
Change in mental health self-informed status from pre-intervention at 8-week, 6-month and 12-month.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Change in mental health self-informed status will be measured using the Mental Health Subscale of the SF-36(v2) Health Survey (Alonso et al., 2003). The Mental Health subscale of the SF-36 Health Survey (Ware et al. 1993; Spanish adaptation by Alonso et al. 1995) is used to identify possible symptoms of depression (e.g., 'Have you felt downhearted and blue?') and anxiety (e.g., 'Have you been a very nervous person?'). This subscale comprises 5 items and uses a 5-point Likert-type response format. Total scores are obtained following instructions provided by Ware et al. (1993). A higher total score (ranging from 1 to 5) indicates a better self-assessment of mental health status.
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.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
This scale uses 14 items scored from 0 (never) to 4 (very often) on a Likert-type scale. Total scores are obtained for each participant, with higher scores representing a higher level of perceived stress.
Change in burnout scores from pre-intervention at 8-week, 6-month and 12-month.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
A single-item measure designed by Dolan et al.(2014) will be used to measure burnout levels. Higher scores (1-5) represent higher levels of burnout.
Change in basal glucose levels
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Basal glucose level is measured in mg/dL (milligrams per decilitre). Reference value: 60 - 100 mg/dL.
Change in cholesterol levels
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Cholesterol level is measured in mg/dL (milligrams per decilitre). Reference value: < 200 mg/dL
Change in triglyceride levels
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Triglyceride levels are measured in mg/dL (milligrams per decilitre). Reference values: < 150 mg/dL After fasting 8 - 10 hours ; < 175 mg/dL Without fasting 8 - 10 hours
Change in High-density lipoprotein (HDL)-Cholesterol levels
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
HDL-Cholesterol levels are measured in mg/dL (milligrams per decilitre). Reference value: > 40 mg/dL.
Change in Low-density lipoprotein (LDL)-Cholesterol levels.
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
LDL-Cholesterol levels are measured in mg/dL (milligrams per decilitre). Reference values: < 116 mg/dL for patients with low CV risk; < 100 mg/dL for patients with moderate CV risk; < 70 mg/dL for patients at high CV risk; < 55 mg/dL for patients with very high CV risk.
Change ultrasensitive C-Reactive Protein (CRP) levels
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Ultrasensitive C-Reactive Protein (CRP) levels are measured in mg/dL (milligrams per decilitre). Reference value: < 0.3 mg/dL
Change in the lipemia index
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Lipemia index is measured in mg/dL (milligrams per decilitre). Reference values for 5 levels indicating a progressive increase in index intensity: 0 - 50 mg/dL (No); 50 - 100 mg/dL ; 100 - 150 mg/dL; 150 - 200 mg/dL;200 - 9999999 mg/dL (Higher).
Change in the jaundice index
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Jaundice index is measured in mg/dL (milligrams per decilitre). Reference values for 5 levels indicating a progressive increase in index intensity: 0 - 2 mg/dL (No); 2 - 4 mg/dL; 4 - 10 mg/dL;10 - 20 mg/dL; 20 - 9999999 mg/dL (Higher).
Change in the hemolysis index
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Hemolysis index is measured in mg/dL (milligrams per decilitre). Reference values for 5 levels indicating a progressive increase in index intensity: < 30 mg/dL (No); 30 - 100 mg/dL; 100 - 200 mg/dL; 200 - 500 mg/dL; 500 - 9999999 mg/dL (Higher).
Change in the levels of aspartate aminotransferase (GOT/AST)
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
The levels of aspartate aminotransferase (GOT/AST) are measured in U/L (units per liter) at 37ºC. Reference value: 8 - 43 U/L at 37 ºC
Change in lactate dehydrogenase (LDH) levels
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Lactate dehydrogenase (LDH) levels are measured in U/L (units per liter) at 37ºC. Reference value: 125 - 220 U/L at 37 ºC
Change in Creatin Kinase (CK) levels
Time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)
Creatin Kinase (CK) levels levels are measured in U/L (units per liter) at 37ºC. Reference value: < 167 U/L at 37 ºC.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Background: PubMed 23070875Neff 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.
Background: PubMed 23775511Germer 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.
BackgroundGermer, 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/
BackgroundGermer, C., & Neff, K. (2019). Teaching the mindful self-compassion program: A guide for professionals. New York: Guilford Publications.
BackgroundNeff, 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.
BackgroundNeff, 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.
BackgroundYela, 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
Background: PubMed 31981226Yela 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.
Background: PubMed 34904363Yela 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.
BackgroundJiménez-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
BackgroundMelero, 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.
BackgroundStahl, B., & Goldstein, E. (2019). A mindfulness-based stress reduction workbook. New Harbinger publications.
Research project websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

José Ramón Yela, PhD principal investigator

Universidad Pontificia de Salamanca

Antonio Crego, PhD principal investigator

Universidad Pontificia de Salamanca

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in perceived general health status from pre-intervention at 8-week, 6-month and 12-month. (time frame: T1 (pre), T2 (8-week), T3 (6-month), T4 (12-month)). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05695586, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.