Clinical Trials Directory

Trials / Completed

CompletedNCT05516355

Psychological and Neurobiological Impact of a Retreat Based on Mindfulness and Compassion for Stress Reduction.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
49 (actual)
Sponsor
Universidad Complutense de Madrid · Academic / Other
Sex
All
Age
25 Years – 65 Years
Healthy volunteers
Accepted

Summary

The study is aimed at comparing the differential effects of two widely used standardized meditation programs: Mindfulness-Based Stress Reduction (MBSR) and Compassion Cultivation Training (CCT) delivered in a retreat format with a cross-over design in a general population sample of healthy adults.

Detailed description

The main objective of the study is to evaluate the effects of two mindfulness-based intensive interventions: Mindfulness-Based Stress Reduction (MBSR) training or Compassion Cultivation Training (CCT), on psychological, physiological and epigenetic changes in a population of health volunteer adults. During a 7-day retreat participants will be randomised to two study arms: group 1 and 2, beginning either with a 3-day MBSR training or a 3-day CCT training. On the 4th day they will cross-over to the opposite intervention. To address this goal, the effects will be measured by self-report questionnaires belonging to different domains (mindfulness, compassion, well-being, psychological distress, and psychological functioning), psychophysiological measures (EEG resting state, Diurnal cortisol slope, EKG and respiration patterns), epigenetic changes (DNA methylation biomarkers) and an objective stress task (Arithmetic Stress Test). Psychobiological outcome measures will be collected from both groups on day 1 (pre-intervention), on day 4 (post intervention and before beginning of the second intervention). The third assessment will be conducted on day 7 for both groups (post-second intervention). A 6-month follow-up assessment will be carried in both groups only for psychological questionnaires. Data analysis will include change scores in psychological outcome measures as well as DNA methylation (by EPIC arrays) and gene expression (RNA-seq) measures.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMindfulness-Based Stress ReductionThe MBSR is an 8-week standardized program (Kabat-Zinn,1990). During the retreat, participants will receive intensive training during 3 days (from 4:00pm to 9pm the first day and from 7 am to 10 pm including breaks, the second and third days), including focused attention on the breath, open monitoring of awareness in body-scanning, prosocial meditation (i.e. loving kindness and compassion) and gentle yoga. Training is delivered by certified instructors by the University of Massachusetts Centre for Mindfulness (https://www.umassmed.edu/cfm/).
BEHAVIORALCompassion Cultivation TrainingThe CCT is an 8-week standardized program (Jinpa, 2010; Jazaieri et al. 2013, 2014) consisting of daily formal and informal practices. Training will be conducted during 3 days of the retreat (same schedule as the MBSR training). The CCT consists of six sequential steps: 1) Settling the mind and learn how to focus it; 2) Loving kindness and compassion for a loved one practice; 3) Loving kindness and compassion for oneself practice; 4) compassion toward others, embracing shared common humanity and developing appreciation of others; 5) compassion toward others including all beings; and 6) active compassion practices (Tonglen) which involve explicit evocation of the altruistic wish to do something about others' suffering. CCT program is delivered by certified instructors by the University of Stanford Centre for Compassion and Altruism Research and Education (http://ccare.stanford.edu/).

Timeline

Start date
2022-07-01
Primary completion
2022-08-30
Completion
2022-08-30
First posted
2022-08-25
Last updated
2022-11-04

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05516355. Inclusion in this directory is not an endorsement.