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

Sponsor

Universidad Complutense de Madrid (Other)

Overall Status

Recruiting

CT.gov ID

NCT05516355

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mindfulness Compassion Psychophysiologic Reaction Psychological Distress Emotion Regulation Stress	Behavioral: Mindfulness-Based Stress Reduction Behavioral: Compassion Cultivation Training	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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/). Other Names: MBSR 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/). Other Names: CCT
Experimental: 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.	Behavioral: 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/). Other Names: MBSR 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/). Other Names: CCT

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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/).

Other Names:

MBSR

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/).

Other Names:

CCT

Experimental: 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.

Behavioral: Mindfulness-Based Stress Reduction

Other Names:

MBSR

Behavioral: Compassion Cultivation Training

Other Names:

CCT

Outcome Measures

Primary Outcome Measures

Epigenetic changes [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)]
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.
Change in Psychological distress [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)]
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.
Change in Stress Reactivity [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)]
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).
Change in Resting State Activity [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)]
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.
Change in Cortisol activity [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]
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.
Change in Emotion regulation in retrieving autobiographical negative memories [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)]
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).

Secondary Outcome Measures

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)]
State Mindfulness Scale (SMS) - (Tanay y Bernstein, 2013). The SMS has 21 items with a response scale from 1 (not at all) to 5 (very well) to indicate how well the statements describe their current mindfulness state. Higher scores represent higher states of current mindfulness.
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)]
Meditation-Related Adverse Effects Scale - Mindfulness-Based Program (MRAESMBP) -Britton et al. (2018). This is an 11-item scale measuring the frequency of challenging or distressful experiences during meditation practice.
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)]
State Self-compassion Scale (SSCS), (Neff et al., 2021). It is a 6-item scale measuring compassion towards oneself using a 5-'point scale (1=Not at all true for me; 5= Very true for me). HIgher scores indicate higher levels of self-compassion.
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)]
We will use the Fear of Expressing Compassion towards yourself subscale from the Fear of Compassion Scale (Gilbert et al. (2011). This is a 15-item scale to assess individuals' difficulties to feel or express self-compassion. We by using a 5-point Likert scale (0=Don't agree at all; 4=Completely agree). Higher scores indicate higher levels of fear of compassion towards oneself.
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)]
A scale measuring current general positive and negative mood (PANAS). It includes 20 adjectives (10 positive, 10 negative) to assess current mood in a scale from 1 (Not all) to 5 (Extremely). Higher scores represent higher positive or negative mood states. We will use the sum of positive items and negative items to provide two separate overall scores.
Change in Psychological well-being - Satisfaction with life [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)]
Satisfaction With Life Scale (SWLS), (Diener et al., 1985). This is a 5-item scale assessing satisfaction with life. Higher scores indicate higher levels of satisfaction with life.
Change in Somatic Symptoms [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)]
Patient Health Questionnaire (PHQ-15), (Kroenke et al., 2002). The PHQ-15 comprises 15 somatic symptoms from the PHQ, each symptom scored from 0 ("not bothered at all") to 2 ("bothered a lot"). A sum score will be used to analyze somatic symptoms.
Change in Emotion Regulation [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)]
State Difficulties in Emotion Regulation (S-DERS-21), (Lavender et al., 2017). This is a 21-item scale in which participants rate their difficulties to regulate their mood in a 5-point Likert scale (1=Not alll; 5=Completely). Higher scores indicate more difficulties in emotion regulation.
Change in Anxiety state and trait [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)]
State-Trait Anxiety Inventory (STAI-20), (Spielberger et al., 1983)
Change in Sleep difficulties [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)]
DSM-5 sleep difficulties (APA, 2013). This is the single item included in the Self-rated level 1 Cross-Cutting Symptom Measure (DSM-5, APA 2013). It measures quality of sleep using a 5-point scale (0=Very good; 4= Very bad).
Program satisfaction [Mid-intervention (T2: Day 4 in the 7-day program), and post-intervention (T3: Day 7 in the 7-day program)]
Client Satisfaction Questionnaire (CSQ-8)- Atkinson and Zwicq (1982). It measures satisfaction with the course of psychological interventions. Participants must rate their satisfaction on 8 items in 4-point scale. Higher scores indicate higher satisfaction with the program.
Daily assessments of psychological functioning [Daily, at the end of the day, during the 7-day retreat]
Experience Sampling Methods on measures of: mindfulness, mind wandering, compassion to others, self-compassion, wellbeing, richness of life, and utility of the contents of the program that day. These are 'ad hoc' single items, taken from well-validated measures, to have a quick daily assessment of psychological functioning. Each item is assessed in a 5-point Likert scale (0=Never; 4= Always).
Change in Affect [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)]
Hedonic and Arousal Affect Scale (HAAS), (Roca et al., 2021). This is a 12-item scale measuring affective states by including adjectives low or high in arousal and positive or negative in valence. Participants are asked to rate their affective experiences in a 5-point Likert scale (0=Not at all; 4= Absolutely).

Other Outcome Measures

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)]
Measurement of cardiac activity during EEG sessions. EKG will be used in the preprocessing procedure to insulate electrophysiological artifacts due to heart activity. In addition, the heart signals will be assessed to obtain heart variability and heart rate indicators.
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)]
Measurement of respiratory activity during EEG sessions. Respiratory signals will be employed in an specific analysis where the EEG data will be split in two blocks (inhalation and exhalation).

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.