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

NCT05516355 | Completed

• 1 other identifier: ESCORIAL RETREAT 2022
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

MBSR; CCT; Mindfulness; Compassion; Epigenetics; Stress

Outcome Measures

Primary Outcomes (6)

• Epigenetic changes

  Blood samples: 20 ml collected in the standard tubes used in clinical haematology that contain EDTA as an anticoagulant. From this biological material, DNA and RNA will be extracted according to the standard molecular biology procedures, in order to subsequently measure DNA methylation (by EPIC arrays) and gene expression (RNA-seq), respectively.

  Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)

• Change in Psychological distress

  Depression Anxiety Stress Scales (DASS-21), (Lovibond and Lovibond, 1995). The DASS-21 is a 21-item scale containing 3 subscales (Anxiety, Depression and Stress), with 7 items for each subscale. Participants are asked to rate each item using 4-point Likert scale (0=Not applicable to me; 3=Very applicable to me). Higher scores correspond to higher levels of severity of anxiety, stress, and depression.

  Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)

• Change in Stress Reactivity

  Mathematical Stress Test: a standardized laboratory stress induction procedure (Kirshbaum et al., 1992). Individuals are asked to repeatedly subtract a given 2-digit number from a 4-digit number. Time is limited to 3 minutes and participants are told that this is a mental speed task and their performance will be evaluated. Stress levels will be evaluated with an affective adjective checklist (PANAS scales).

  Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)

• Change in Resting State Activity

  EEG resting state (alternating open and closed eyes). EEG resting state will be recorded with four 64-channel EEG devices with laptop and eego EEG recording software. The sampling rate will be 1000 Hz and the reference to be used will be 7Z of the equidistant layout. The interventions will significantly change the EEG spectral profile of the resting state brain activity. We expect changes in the balance between Alpha (8-14 Hz) and Theta (4-8 Hz) frequency bands.

  Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)

• Change in Cortisol activity

  Cortisol samples 1.5 - 2.0 ml will be collected in Salivette® cortisol saliva sample collection tubes (Sarstedt, Germany) that contain sterile cotton plugs for sample absorption. From this biological material, levels of the principal stress corticosteroid, the hormone cortisol, will be assessed in order to subsequently measure the Diurnal Cortisol Slope and cortisol levels at awakening and bedtime. Using saliva collection tubes, levels of the principal stress corticosteroid, the hormone cortisol, will be assessed in order to subsequently measure the Diurnal Cortisol Slope and cortisol levels at awakening and bedtime at three different moments of the retreat.

  Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program

• Change in Emotion regulation in retrieving autobiographical negative memories

  A 10-min guided test to retrieve one personally painful memory. Affect changes will be asssed before and after the task by using a checklist of affective adjectives (PANAS).

  Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)

Secondary Outcomes (13)

• Change in Mindfulness State

  Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)

• Change in Mindfulness - Adverse Effects

  Mid-intervention (T2: Day 4 in the 7-day program), post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)

• Change in Compassion - State self-compassion

  Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)

• Change in Compassion - Fear of Compassion

  Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)

• Change in current mood

  Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program), and 3-month follow-up (T4)

Other Outcomes (2)

• EKG activity

  ime Frame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)

• Respiratory patterns

  ime Frame: Pre-intervention (T1: Day 1 in the 7-day program), mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)

Study Arms (2)

Group 1 (MBSR + CCT)

EXPERIMENTAL

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.

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

Group 2 (CCT + MBSR)

EXPERIMENTAL

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.

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

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

The 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/).

Also known as: MBSR

Group 1 (MBSR + CCT); Group 2 (CCT + MBSR)

Compassion Cultivation Training BEHAVIORAL

The 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/).

Also known as: CCT

Group 1 (MBSR + CCT); Group 2 (CCT + MBSR)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult participants.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid - Faculty of Psychology

Madrid, 28223, Spain

Location

Related Publications (29)

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MeSH Terms

Conditions

Emotional Regulation

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carmelo Vazquez, Ph.D.

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: MBSR and CCT instructors will be blind to the study hypotheses. Investigators collecting, analyzing data and assessing outcomes will be blind to the group assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Psychopathology

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 25, 2022
• Study Start: July 1, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)