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

Universidad Complutense de Madrid

Status: Completed

Conditions: Compassion; Mindfulness; Psychophysiologic Reaction; Emotion Regulation; Stress; Psychological Distress

Treatments: Behavioral: Mindfulness-Based Stress Reduction; Behavioral: Compassion Cultivation Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05516355

ESCORIAL RETREAT 2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult participants.

Exclusion criteria

• Current or past self-reported diagnosable serious or disabling mental disorder (in particular, PTSD, major depression, psychotic disorders, and/or Use of alcohol or drugs disorders).
• Presenting current health conditions that might affect the immune system (i.e. autoimmune disease, chronic severe infections, HIV, cancer) or past history of the same (less than 5 years from total recovery).
• Presenting current habits that might affect the immune system (i.e. smoking, alcoholism, substance abuse).
• Being under medical treatment that might affect the immune system response and inflammatory processes (i.e. corticoids).
• Travelling from a different time zone/long-travel times that might affect the immune system.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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49 participants in 2 patient groups

Group 1 (MBSR + CCT)

Experimental group

Description:

Group 1 will begin the retreat with a 3-day MBSR intervention. On day 4 of the retreat, they will crossover and begin a 3-day CCT intervention.

Treatment:

Behavioral: Compassion Cultivation Training

Behavioral: Mindfulness-Based Stress Reduction

Group 2 (CCT + MBSR)

Experimental group

Description:

Group 2 will begin the retreat with a 3-day CCT intervention. On day 4 of the retreat, they will crossover and begin a 3-day MBSR intervention.

Treatment:

Behavioral: Compassion Cultivation Training

Behavioral: Mindfulness-Based Stress Reduction