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

NCT ID: NCT05516355

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-08-30

Brief Summary

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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

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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

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Mindfulness Compassion Psychophysiologic Reaction Psychological Distress Emotion Regulation Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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Group 1 (MBSR + CCT)

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.

Group Type EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type 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/).

Compassion Cultivation Training

Intervention Type 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/).

Group 2 (CCT + MBSR)

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.

Group Type EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type 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/).

Compassion Cultivation Training

Intervention Type 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/).

Interventions

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Mindfulness-Based Stress Reduction

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/).

Intervention Type BEHAVIORAL

Compassion Cultivation Training

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/).

Intervention Type BEHAVIORAL

Other Intervention Names

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MBSR CCT

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Carmelo Vázquez

Full Professor of Psychopathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carmelo Vazquez, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Locations

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Universidad Complutense de Madrid - Faculty of Psychology

Madrid, , Spain

Site Status

Countries

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Spain

References

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Other Identifiers

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ESCORIAL RETREAT 2022

Identifier Type: -

Identifier Source: org_study_id

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