Prevention of Burnout in Spanish Healthcare Professionals Through Attachment-Based Compassion Therapy (ABCT)

August 22, 2026 updated by: Javier Garcia Campayo, Hospital Miguel Servet

Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services: A Randomized Controlled Trial

Burnout is a common problem among healthcare professionals and may affect their psychological well-being, quality of life, and professional functioning. This study will examine whether an intensive compassion-based intervention can help reduce burnout and improve well-being in healthcare professionals. Participants will be randomly assigned to either an Attachment-Based Compassion Therapy intervention or a relaxation intervention. Outcomes will be measured before the intervention, immediately after the intervention, and three months later.

Attachment-Based Compassion groups will be composed of 80 participants each, and TAU group will be composed of 80 participants (total sample n = 160).

Burnout Inventory-Human Services Survey - MBI-HSS. Burnout will be assessed using the Maslach Burnout Inventory-Human Services Survey. This questionnaire evaluates the three main dimensions of burnout: emotional exhaustion, depersonalization, and personal accomplishment.

Items are rated on a Likert-type scale according to the frequency with which the participant experiences each symptom. Scores are calculated separately for each burnout dimension.

In this study, emotional exhaustion and depersonalization will be considered the primary outcome variables, while reduced personal accomplishment will be considered a secondary outcome variable

Study Overview

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Spain
      • Zaragoza, Spain, Spain, 50009
        • Recruiting
        • Miguel Servet University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Active healthcare professionals (physicians and nurses) of both sexes.
  2. Understanding of spoken and written Spanish.
  3. Availability of a computer and internet connection.
  4. Written informed consent.

Exclusion Criteria:

  • Previous psychological treatment within the last year, or current psychological treatment.

Presence of a severe uncontrolled medical, infectious, or degenerative disease that may interfere with affective symptoms.

Presence of a mental disorder related to substance dependence/abuse, or any other disease affecting the central nervous system.

Suicide risk, defined as a score of ≥2 on item 9 of the PHQ-9. Scheduled surgical intervention during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Compassion condition
one weekend group sessions, held Friday evening, Saturday morning and evening and Sunday morning

Program consists of 8 session of 120 minutes/session (15-20 people) Written material andsound recordings will be offered as support elements.

The estimated duration of the program is one weekend

Experimental: Relaxation condition
one weekend group sessions, held Friday evening, Saturday morning and evening and Sunday morning

Relaxation program consists of 8 sessions of 120 minutes/session (15-20 people) Written material and sound recordings will be offered as support elements.

The estimated duration of the program is one weekend

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Baseline
In the compassion program group. Burnout will be assessed using the Maslach Burnout Inventory Human Services Survey. This questionnaire evaluates three main dimensions of burnout in healthcare professionals: emotional exhaustion, depersonalization, and personal accomplishment. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "never or almost never" and 6 indicates "almost always or always". Participants rate the frequency with which they experience each symptom. Higher scores on emotional exhaustion and depersonalization indicate a worse outcome, reflecting higher levels of burnout. Higher scores on personal accomplishment indicate a better outcome, whereas lower scores indicate reduced personal accomplishment and a worse outcome.
Baseline
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: baseline
In the relaxation program group. Burnout will be assessed using the Maslach Burnout Inventory Human Services Survey. This questionnaire evaluates three main dimensions of burnout in healthcare professionals: emotional exhaustion, depersonalization, and personal accomplishment. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "never or almost never" and 6 indicates "almost always or always". Participants rate the frequency with which they experience each symptom. Higher scores on emotional exhaustion and depersonalization indicate a worse outcome, reflecting higher levels of burnout. Higher scores on personal accomplishment indicate a better outcome, whereas lower scores indicate reduced personal accomplishment and a worse outcome.
baseline
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Post-treatment 1 weekend from baseline
In the compassion program group. Burnout will be assessed using the Maslach Burnout Inventory Human Services Survey. This questionnaire evaluates three main dimensions of burnout in healthcare professionals: emotional exhaustion, depersonalization, and personal accomplishment. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "never or almost never" and 6 indicates "almost always or always". Participants rate the frequency with which they experience each symptom. Higher scores on emotional exhaustion and depersonalization indicate a worse outcome, reflecting higher levels of burnout. Higher scores on personal accomplishment indicate a better outcome, whereas lower scores indicate reduced personal accomplishment and a worse outcome.
Post-treatment 1 weekend from baseline
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Post-treatment 1 weekend from baseline
In the relaxation program group. Burnout will be assessed using the Maslach Burnout Inventory Human Services Survey. This questionnaire evaluates three main dimensions of burnout in healthcare professionals: emotional exhaustion, depersonalization, and personal accomplishment. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "never or almost never" and 6 indicates "almost always or always". Participants rate the frequency with which they experience each symptom. Higher scores on emotional exhaustion and depersonalization indicate a worse outcome, reflecting higher levels of burnout. Higher scores on personal accomplishment indicate a better outcome, whereas lower scores indicate reduced personal accomplishment and a worse outcome.
Post-treatment 1 weekend from baseline
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Three-months follow-up]
In the compassion program group. Burnout will be assessed using the Maslach Burnout Inventory Human Services Survey. This questionnaire evaluates three main dimensions of burnout in healthcare professionals: emotional exhaustion, depersonalization, and personal accomplishment. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "never or almost never" and 6 indicates "almost always or always". Participants rate the frequency with which they experience each symptom. Higher scores on emotional exhaustion and depersonalization indicate a worse outcome, reflecting higher levels of burnout. Higher scores on personal accomplishment indicate a better outcome, whereas lower scores indicate reduced personal accomplishment and a worse outcome.
Three-months follow-up]
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Three-months follow-up]
In the relaxation program group. Burnout will be assessed using the Maslach Burnout Inventory Human Services Survey. This questionnaire evaluates three main dimensions of burnout in healthcare professionals: emotional exhaustion, depersonalization, and personal accomplishment. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "never or almost never" and 6 indicates "almost always or always". Participants rate the frequency with which they experience each symptom. Higher scores on emotional exhaustion and depersonalization indicate a worse outcome, reflecting higher levels of burnout. Higher scores on personal accomplishment indicate a better outcome, whereas lower scores indicate reduced personal accomplishment and a worse outcome.
Three-months follow-up]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Baseline

In the compassion program group. Burnout will be assessed using the Maslach Burnout Inventory Human Services Survey. This questionnaire evaluates three main dimensions of burnout in healthcare professionals: emotional exhaustion, depersonalization, and personal accomplishment. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "never or almost never" and 6 indicates "almost always or always". Participants rate the frequency with which they experience each symptom. Higher scores on emotional exhaustion and depersonalization indicate a worse outcome, reflecting higher levels of burnout. Higher scores on personal accomplishment indicate a better outcome, whereas lower scores indicate reduced personal accomplishment and a worse outcome.

It is the same questionnaire, but the variables measured in point 1, emotional exhaustion and depersonalization, are considered primary variables, whereas lack of personal accomplishment is considered a secondary variable.

Baseline
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: baseline

In the relaxation program group. Burnout will be assessed using the Maslach Burnout Inventory Human Services Survey. This questionnaire evaluates three main dimensions of burnout in healthcare professionals: emotional exhaustion, depersonalization, and personal accomplishment. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "never or almost never" and 6 indicates "almost always or always". Participants rate the frequency with which they experience each symptom. Higher scores on emotional exhaustion and depersonalization indicate a worse outcome, reflecting higher levels of burnout. Higher scores on personal accomplishment indicate a better outcome, whereas lower scores indicate reduced personal accomplishment and a worse outcome.

It is the same questionnaire, but the variables measured in point 1, emotional exhaustion and depersonalization, are considered primary variables, whereas lack of personal accomplishment is considered a secondary variable.

baseline
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Post-treatment 1 weekend from baseline

In the compassion program group. Burnout will be assessed using the Maslach Burnout Inventory Human Services Survey. This questionnaire evaluates three main dimensions of burnout in healthcare professionals: emotional exhaustion, depersonalization, and personal accomplishment. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "never or almost never" and 6 indicates "almost always or always". Participants rate the frequency with which they experience each symptom. Higher scores on emotional exhaustion and depersonalization indicate a worse outcome, reflecting higher levels of burnout. Higher scores on personal accomplishment indicate a better outcome, whereas lower scores indicate reduced personal accomplishment and a worse outcome.

It is the same questionnaire, but the variables measured in point 1, emotional exhaustion and depersonalization, are considered primary variables, whereas lack of personal accomplishment is considered a secondary variable.

Post-treatment 1 weekend from baseline
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Post-treatment 1 weekend from baseline

In the relaxation program group. Burnout will be assessed using the Maslach Burnout Inventory Human Services Survey. This questionnaire evaluates three main dimensions of burnout in healthcare professionals: emotional exhaustion, depersonalization, and personal accomplishment. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "never or almost never" and 6 indicates "almost always or always". Participants rate the frequency with which they experience each symptom. Higher scores on emotional exhaustion and depersonalization indicate a worse outcome, reflecting higher levels of burnout. Higher scores on personal accomplishment indicate a better outcome, whereas lower scores indicate reduced personal accomplishment and a worse outcome.

It is the same questionnaire, but the variables measured in point 1, emotional exhaustion and depersonalization, are considered primary variables, whereas lack of personal accomplishment is considered a secondary variable.

Post-treatment 1 weekend from baseline
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Three-months follow-up]

In the compassion program group. Burnout will be assessed using the Maslach Burnout Inventory Human Services Survey. This questionnaire evaluates three main dimensions of burnout in healthcare professionals: emotional exhaustion, depersonalization, and personal accomplishment. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "never or almost never" and 6 indicates "almost always or always". Participants rate the frequency with which they experience each symptom. Higher scores on emotional exhaustion and depersonalization indicate a worse outcome, reflecting higher levels of burnout. Higher scores on personal accomplishment indicate a better outcome, whereas lower scores indicate reduced personal accomplishment and a worse outcome.

It is the same questionnaire, but the variables measured in point 1, emotional exhaustion and depersonalization, are considered primary variables, whereas lack of personal accomplishment is considered a secondary variable.

Three-months follow-up]
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Three-months follow-up]

In the relaxation program group. Burnout will be assessed using the Maslach Burnout Inventory Human Services Survey. This questionnaire evaluates three main dimensions of burnout in healthcare professionals: emotional exhaustion, depersonalization, and personal accomplishment. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "never or almost never" and 6 indicates "almost always or always". Participants rate the frequency with which they experience each symptom. Higher scores on emotional exhaustion and depersonalization indicate a worse outcome, reflecting higher levels of burnout. Higher scores on personal accomplishment indicate a better outcome, whereas lower scores indicate reduced personal accomplishment and a worse outcome.

It is the same questionnaire, but the variables measured in point 1, emotional exhaustion and depersonalization, are considered primary variables, whereas lack of personal accomplishment is considered a secondary variable

Three-months follow-up]
Burnout Clinical Subtype Questionnaire BCSQ-12
Time Frame: Baseline
In the compassion program group. Clinical burnout subtypes will be assessed using the Burnout Clinical Subtype Questionnaire-12. This questionnaire evaluates three burnout profiles in healthcare professionals: overload, lack of development, and neglect/wear-out. It includes 12 items distributed across these three dimensions, with four items per dimension. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "totally disagree" and 6 indicates "totally agree". Participants select the response that best reflects how frequently they have experienced each statement. Item scores are summed separately for each subscale, obtaining a raw score for each dimension. Higher scores indicate a greater presence of the corresponding burnout subtype and therefore a worse outcome.
Baseline
Burnout Clinical Subtype Questionnaire BCSQ-12
Time Frame: baseline
In the relaxation program group. Clinical burnout subtypes will be assessed using the Burnout Clinical Subtype Questionnaire-12. This questionnaire evaluates three burnout profiles in healthcare professionals: overload, lack of development, and neglect/wear-out. It includes 12 items distributed across these three dimensions, with four items per dimension. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "totally disagree" and 6 indicates "totally agree". Participants select the response that best reflects how frequently they have experienced each statement. Item scores are summed separately for each subscale, obtaining a raw score for each dimension. Higher scores indicate a greater presence of the corresponding burnout subtype and therefore a worse outcome.
baseline
Burnout Clinical Subtype Questionnaire BCSQ-12
Time Frame: Post-treatment 1 weekend from baseline
In the compassion program group. Clinical burnout subtypes will be assessed using the Burnout Clinical Subtype Questionnaire-12. This questionnaire evaluates three burnout profiles in healthcare professionals: overload, lack of development, and neglect/wear-out. It includes 12 items distributed across these three dimensions, with four items per dimension. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "totally disagree" and 6 indicates "totally agree". Participants select the response that best reflects how frequently they have experienced each statement. Item scores are summed separately for each subscale, obtaining a raw score for each dimension. Higher scores indicate a greater presence of the corresponding burnout subtype and therefore a worse outcome.
Post-treatment 1 weekend from baseline
Burnout Clinical Subtype Questionnaire BCSQ-12
Time Frame: Post-treatment 1 weekend from baseline
In the relaxation program group. Clinical burnout subtypes will be assessed using the Burnout Clinical Subtype Questionnaire-12. This questionnaire evaluates three burnout profiles in healthcare professionals: overload, lack of development, and neglect/wear-out. It includes 12 items distributed across these three dimensions, with four items per dimension. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "totally disagree" and 6 indicates "totally agree". Participants select the response that best reflects how frequently they have experienced each statement. Item scores are summed separately for each subscale, obtaining a raw score for each dimension. Higher scores indicate a greater presence of the corresponding burnout subtype and therefore a worse outcome.
Post-treatment 1 weekend from baseline
Burnout Clinical Subtype Questionnaire BCSQ-12
Time Frame: Three-months follow-up]
In the compassion program group. Clinical burnout subtypes will be assessed using the Burnout Clinical Subtype Questionnaire-12. This questionnaire evaluates three burnout profiles in healthcare professionals: overload, lack of development, and neglect/wear-out. It includes 12 items distributed across these three dimensions, with four items per dimension. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "totally disagree" and 6 indicates "totally agree". Participants select the response that best reflects how frequently they have experienced each statement. Item scores are summed separately for each subscale, obtaining a raw score for each dimension. Higher scores indicate a greater presence of the corresponding burnout subtype and therefore a worse outcome.
Three-months follow-up]
Burnout Clinical Subtype Questionnaire BCSQ-12
Time Frame: Three-months follow-up]
In the relaxation program group. Clinical burnout subtypes will be assessed using the Burnout Clinical Subtype Questionnaire-12. This questionnaire evaluates three burnout profiles in healthcare professionals: overload, lack of development, and neglect/wear-out. It includes 12 items distributed across these three dimensions, with four items per dimension. Each item is scored on a Likert-type scale ranging from 0 to 6, where 0 indicates "totally disagree" and 6 indicates "totally agree". Participants select the response that best reflects how frequently they have experienced each statement. Item scores are summed separately for each subscale, obtaining a raw score for each dimension. Higher scores indicate a greater presence of the corresponding burnout subtype and therefore a worse outcome.
Three-months follow-up]
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time Frame: Baseline
In the compassion program group. Self-compassion will be assessed using the Sussex-Oxford Compassion for the Self Scale. This self-report measure evaluates compassion toward oneself. It includes 20 items distributed across five subscales: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating the discomfort associated with suffering, and acting or being motivated to alleviate suffering. Each item is scored on a scale ranging from 1 to 5, where 1 indicates "not at all true" and 5 indicates "always true". Participants select the response that best reflects their experience. Higher scores indicate greater self-compassion and therefore a better outcome. The Spanish validation has shown adequate psychometric properties.
Baseline
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time Frame: baseline
In the relaxation program group. Self-compassion will be assessed using the Sussex-Oxford Compassion for the Self Scale. This self-report measure evaluates compassion toward oneself. It includes 20 items distributed across five subscales: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating the discomfort associated with suffering, and acting or being motivated to alleviate suffering. Each item is scored on a scale ranging from 1 to 5, where 1 indicates "not at all true" and 5 indicates "always true". Participants select the response that best reflects their experience. Higher scores indicate greater self-compassion and therefore a better outcome. The Spanish validation has shown adequate psychometric properties.
baseline
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time Frame: Post-treatment 1 weekend from baseline
In the compassion program group. Self-compassion will be assessed using the Sussex-Oxford Compassion for the Self Scale. This self-report measure evaluates compassion toward oneself. It includes 20 items distributed across five subscales: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating the discomfort associated with suffering, and acting or being motivated to alleviate suffering. Each item is scored on a scale ranging from 1 to 5, where 1 indicates "not at all true" and 5 indicates "always true". Participants select the response that best reflects their experience. Higher scores indicate greater self-compassion and therefore a better outcome. The Spanish validation has shown adequate psychometric properties.
Post-treatment 1 weekend from baseline
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time Frame: Post-treatment 1 weekend from baseline
In the relaxation program group. Self-compassion will be assessed using the Sussex-Oxford Compassion for the Self Scale. This self-report measure evaluates compassion toward oneself. It includes 20 items distributed across five subscales: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating the discomfort associated with suffering, and acting or being motivated to alleviate suffering. Each item is scored on a scale ranging from 1 to 5, where 1 indicates "not at all true" and 5 indicates "always true". Participants select the response that best reflects their experience. Higher scores indicate greater self-compassion and therefore a better outcome. The Spanish validation has shown adequate psychometric properties.
Post-treatment 1 weekend from baseline
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time Frame: Three-months follow-up]
In the compassion program group. Self-compassion will be assessed using the Sussex-Oxford Compassion for the Self Scale. This self-report measure evaluates compassion toward oneself. It includes 20 items distributed across five subscales: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating the discomfort associated with suffering, and acting or being motivated to alleviate suffering. Each item is scored on a scale ranging from 1 to 5, where 1 indicates "not at all true" and 5 indicates "always true". Participants select the response that best reflects their experience. Higher scores indicate greater self-compassion and therefore a better outcome. The Spanish validation has shown adequate psychometric properties.
Three-months follow-up]
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time Frame: Three-months follow-up]
In the relaxation program group. Self-compassion will be assessed using the Sussex-Oxford Compassion for the Self Scale. This self-report measure evaluates compassion toward oneself. It includes 20 items distributed across five subscales: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating the discomfort associated with suffering, and acting or being motivated to alleviate suffering. Each item is scored on a scale ranging from 1 to 5, where 1 indicates "not at all true" and 5 indicates "always true". Participants select the response that best reflects their experience. Higher scores indicate greater self-compassion and therefore a better outcome. The Spanish validation has shown adequate psychometric properties.
Three-months follow-up]
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Time Frame: Baseline
In the compassion program group. Compassion for others will be assessed using the Sussex-Oxford Compassion for Others Scale. This self-report measure evaluates compassion toward other people. It includes 20 items distributed across five subscales: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating the discomfort associated with suffering, and acting or being motivated to alleviate suffering. Each item is scored on a scale ranging from 1 to 5, where 1 indicates "not at all true" and 5 indicates "always true". Participants select the response that best reflects their experience. Higher scores indicate greater compassion for others and therefore a better outcome. The Spanish validation has shown adequate psychometric properties.
Baseline
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Time Frame: baseline
In the relaxation program group. Compassion for others will be assessed using the Sussex-Oxford Compassion for Others Scale. This self-report measure evaluates compassion toward other people. It includes 20 items distributed across five subscales: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating the discomfort associated with suffering, and acting or being motivated to alleviate suffering. Each item is scored on a scale ranging from 1 to 5, where 1 indicates "not at all true" and 5 indicates "always true". Participants select the response that best reflects their experience. Higher scores indicate greater compassion for others and therefore a better outcome. The Spanish validation has shown adequate psychometric properties.
baseline
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Time Frame: Post-treatment 1 weekend from baseline
In the compassion program group. Compassion for others will be assessed using the Sussex-Oxford Compassion for Others Scale. This self-report measure evaluates compassion toward other people. It includes 20 items distributed across five subscales: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating the discomfort associated with suffering, and acting or being motivated to alleviate suffering. Each item is scored on a scale ranging from 1 to 5, where 1 indicates "not at all true" and 5 indicates "always true". Participants select the response that best reflects their experience. Higher scores indicate greater compassion for others and therefore a better outcome. The Spanish validation has shown adequate psychometric properties.
Post-treatment 1 weekend from baseline
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Time Frame: Post-treatment 1 weekend from baseline
In the relaxation program group. Compassion for others will be assessed using the Sussex-Oxford Compassion for Others Scale. This self-report measure evaluates compassion toward other people. It includes 20 items distributed across five subscales: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating the discomfort associated with suffering, and acting or being motivated to alleviate suffering. Each item is scored on a scale ranging from 1 to 5, where 1 indicates "not at all true" and 5 indicates "always true". Participants select the response that best reflects their experience. Higher scores indicate greater compassion for others and therefore a better outcome. The Spanish validation has shown adequate psychometric properties.
Post-treatment 1 weekend from baseline
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Time Frame: Three-months follow-up]
In the compassion program group. Compassion for others will be assessed using the Sussex-Oxford Compassion for Others Scale. This self-report measure evaluates compassion toward other people. It includes 20 items distributed across five subscales: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating the discomfort associated with suffering, and acting or being motivated to alleviate suffering. Each item is scored on a scale ranging from 1 to 5, where 1 indicates "not at all true" and 5 indicates "always true". Participants select the response that best reflects their experience. Higher scores indicate greater compassion for others and therefore a better outcome. The Spanish validation has shown adequate psychometric properties.
Three-months follow-up]
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Time Frame: Three-months follow-up]
In the relaxation program group. Compassion for others will be assessed using the Sussex-Oxford Compassion for Others Scale. This self-report measure evaluates compassion toward other people. It includes 20 items distributed across five subscales: recognizing suffering, understanding the universality of suffering, feeling for the person suffering, tolerating the discomfort associated with suffering, and acting or being motivated to alleviate suffering. Each item is scored on a scale ranging from 1 to 5, where 1 indicates "not at all true" and 5 indicates "always true". Participants select the response that best reflects their experience. Higher scores indicate greater compassion for others and therefore a better outcome. The Spanish validation has shown adequate psychometric properties.
Three-months follow-up]
Depression Anxiety Stress Scales - DASS-21
Time Frame: Baseline
In the compassion program group. Anxiety, depression, and stress symptoms will be assessed using the Depression Anxiety Stress Scales - 21. This self-report scale includes 21 items distributed across three subscales: anxiety, depression, and stress. Each item is scored on a 4-point Likert-type scale ranging from 0 to 3, where 0 indicates "never" and 3 indicates "almost always". Participants select the response that best reflects the frequency with which they have experienced each symptom. Item scores are summed separately for each subscale, obtaining a total score for anxiety, depression, and stress. Higher scores indicate greater severity of anxiety, depression, or stress symptoms and therefore a worse outcome. The Spanish validation has shown adequate psychometric properties.
Baseline
Depression Anxiety Stress Scales - DASS-21
Time Frame: baseline
In the relaxation program group. Anxiety, depression, and stress symptoms will be assessed using the Depression Anxiety Stress Scales - 21. This self-report scale includes 21 items distributed across three subscales: anxiety, depression, and stress. Each item is scored on a 4-point Likert-type scale ranging from 0 to 3, where 0 indicates "never" and 3 indicates "almost always". Participants select the response that best reflects the frequency with which they have experienced each symptom. Item scores are summed separately for each subscale, obtaining a total score for anxiety, depression, and stress. Higher scores indicate greater severity of anxiety, depression, or stress symptoms and therefore a worse outcome. The Spanish validation has shown adequate psychometric properties.
baseline
Depression Anxiety Stress Scales - DASS-21
Time Frame: Post-treatment 1 weekend from baseline
In the compassion program group. Anxiety, depression, and stress symptoms will be assessed using the Depression Anxiety Stress Scales - 21. This self-report scale includes 21 items distributed across three subscales: anxiety, depression, and stress. Each item is scored on a 4-point Likert-type scale ranging from 0 to 3, where 0 indicates "never" and 3 indicates "almost always". Participants select the response that best reflects the frequency with which they have experienced each symptom. Item scores are summed separately for each subscale, obtaining a total score for anxiety, depression, and stress. Higher scores indicate greater severity of anxiety, depression, or stress symptoms and therefore a worse outcome. The Spanish validation has shown adequate psychometric properties.
Post-treatment 1 weekend from baseline
Depression Anxiety Stress Scales - DASS-21
Time Frame: Post-treatment 1 weekend from baseline
In the relaxation program group. Anxiety, depression, and stress symptoms will be assessed using the Depression Anxiety Stress Scales - 21. This self-report scale includes 21 items distributed across three subscales: anxiety, depression, and stress. Each item is scored on a 4-point Likert-type scale ranging from 0 to 3, where 0 indicates "never" and 3 indicates "almost always". Participants select the response that best reflects the frequency with which they have experienced each symptom. Item scores are summed separately for each subscale, obtaining a total score for anxiety, depression, and stress. Higher scores indicate greater severity of anxiety, depression, or stress symptoms and therefore a worse outcome. The Spanish validation has shown adequate psychometric properties.
Post-treatment 1 weekend from baseline
Depression Anxiety Stress Scales - DASS-21
Time Frame: Three-months follow-up]
In the compassion program group. Anxiety, depression, and stress symptoms will be assessed using the Depression Anxiety Stress Scales - 21. This self-report scale includes 21 items distributed across three subscales: anxiety, depression, and stress. Each item is scored on a 4-point Likert-type scale ranging from 0 to 3, where 0 indicates "never" and 3 indicates "almost always". Participants select the response that best reflects the frequency with which they have experienced each symptom. Item scores are summed separately for each subscale, obtaining a total score for anxiety, depression, and stress. Higher scores indicate greater severity of anxiety, depression, or stress symptoms and therefore a worse outcome. The Spanish validation has shown adequate psychometric properties.
Three-months follow-up]
Depression Anxiety Stress Scales - DASS-21
Time Frame: Three-months follow-up]
In the relaxation program group. Anxiety, depression, and stress symptoms will be assessed using the Depression Anxiety Stress Scales - 21. This self-report scale includes 21 items distributed across three subscales: anxiety, depression, and stress. Each item is scored on a 4-point Likert-type scale ranging from 0 to 3, where 0 indicates "never" and 3 indicates "almost always". Participants select the response that best reflects the frequency with which they have experienced each symptom. Item scores are summed separately for each subscale, obtaining a total score for anxiety, depression, and stress. Higher scores indicate greater severity of anxiety, depression, or stress symptoms and therefore a worse outcome. The Spanish validation has shown adequate psychometric properties.
Three-months follow-up]
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Time Frame: Baseline
In the compassion program group. Mindfulness will be assessed using the short form of the Five Facet Mindfulness Questionnaire. This self-report scale includes 15 items and evaluates the same five facets as the original version: observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience. Each item is scored on a Likert-type scale ranging from 1 to 5, where 1 indicates "never or very rarely true" and 5 indicates "very often or always true". Participants select the response that best reflects their experience. Higher scores indicate higher levels of mindfulness and therefore a better outcome. The Spanish validated version used in this study has shown a factorial structure consistent with the original scale.
Baseline
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Time Frame: baseline
In the relaxation program group. Mindfulness will be assessed using the short form of the Five Facet Mindfulness Questionnaire. This self-report scale includes 15 items and evaluates the same five facets as the original version: observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience. Each item is scored on a Likert-type scale ranging from 1 to 5, where 1 indicates "never or very rarely true" and 5 indicates "very often or always true". Participants select the response that best reflects their experience. Higher scores indicate higher levels of mindfulness and therefore a better outcome. The Spanish validated version used in this study has shown a factorial structure consistent with the original scale.
baseline
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Time Frame: Post-treatment 1 weekend from baseline
In the compassion program group. Mindfulness will be assessed using the short form of the Five Facet Mindfulness Questionnaire. This self-report scale includes 15 items and evaluates the same five facets as the original version: observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience. Each item is scored on a Likert-type scale ranging from 1 to 5, where 1 indicates "never or very rarely true" and 5 indicates "very often or always true". Participants select the response that best reflects their experience. Higher scores indicate higher levels of mindfulness and therefore a better outcome. The Spanish validated version used in this study has shown a factorial structure consistent with the original scale.
Post-treatment 1 weekend from baseline
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Time Frame: Post-treatment 1 weekend from baseline
In the relaxation program group. Mindfulness will be assessed using the short form of the Five Facet Mindfulness Questionnaire. This self-report scale includes 15 items and evaluates the same five facets as the original version: observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience. Each item is scored on a Likert-type scale ranging from 1 to 5, where 1 indicates "never or very rarely true" and 5 indicates "very often or always true". Participants select the response that best reflects their experience. Higher scores indicate higher levels of mindfulness and therefore a better outcome. The Spanish validated version used in this study has shown a factorial structure consistent with the original scale.
Post-treatment 1 weekend from baseline
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Time Frame: Three-months follow-up]
In the compassion program group. Mindfulness will be assessed using the short form of the Five Facet Mindfulness Questionnaire. This self-report scale includes 15 items and evaluates the same five facets as the original version: observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience. Each item is scored on a Likert-type scale ranging from 1 to 5, where 1 indicates "never or very rarely true" and 5 indicates "very often or always true". Participants select the response that best reflects their experience. Higher scores indicate higher levels of mindfulness and therefore a better outcome. The Spanish validated version used in this study has shown a factorial structure consistent with the original scale.
Three-months follow-up]
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Time Frame: Three-months follow-up]
In the relaxation program group. Mindfulness will be assessed using the short form of the Five Facet Mindfulness Questionnaire. This self-report scale includes 15 items and evaluates the same five facets as the original version: observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience. Each item is scored on a Likert-type scale ranging from 1 to 5, where 1 indicates "never or very rarely true" and 5 indicates "very often or always true". Participants select the response that best reflects their experience. Higher scores indicate higher levels of mindfulness and therefore a better outcome. The Spanish validated version used in this study has shown a factorial structure consistent with the original scale.
Three-months follow-up]
Basic Psychological Needs Satisfaction Scale - General
Time Frame: Baseline
In the compassion program group. Satisfaction and frustration of basic psychological needs will be assessed using the Basic Psychological Needs Satisfaction in General Scale. This self-report scale includes 16 items and evaluates three fundamental psychological needs: autonomy, competence, and relatedness. Each item is scored on a Likert-type scale ranging from 1 to 7, where 1 indicates "totally disagree" and 7 indicates "totally agree". Participants select the response that best reflects their perceived satisfaction or frustration regarding these psychological needs. Item scores are summed to obtain a total score. Higher scores indicate greater satisfaction of basic psychological needs and therefore a better outcome. The Spanish validation of the 16-item version has shown adequate psychometric properties.
Baseline
Basic Psychological Needs Satisfaction Scale - General
Time Frame: baseline
In the relaxation program group. Satisfaction and frustration of basic psychological needs will be assessed using the Basic Psychological Needs Satisfaction in General Scale. This self-report scale includes 16 items and evaluates three fundamental psychological needs: autonomy, competence, and relatedness. Each item is scored on a Likert-type scale ranging from 1 to 7, where 1 indicates "totally disagree" and 7 indicates "totally agree". Participants select the response that best reflects their perceived satisfaction or frustration regarding these psychological needs. Item scores are summed to obtain a total score. Higher scores indicate greater satisfaction of basic psychological needs and therefore a better outcome. The Spanish validation of the 16-item version has shown adequate psychometric properties.
baseline
Basic Psychological Needs Satisfaction Scale - General
Time Frame: Post-treatment 1 weekend from baseline
In the compassion program group. Satisfaction and frustration of basic psychological needs will be assessed using the Basic Psychological Needs Satisfaction in General Scale. This self-report scale includes 16 items and evaluates three fundamental psychological needs: autonomy, competence, and relatedness. Each item is scored on a Likert-type scale ranging from 1 to 7, where 1 indicates "totally disagree" and 7 indicates "totally agree". Participants select the response that best reflects their perceived satisfaction or frustration regarding these psychological needs. Item scores are summed to obtain a total score. Higher scores indicate greater satisfaction of basic psychological needs and therefore a better outcome. The Spanish validation of the 16-item version has shown adequate psychometric properties.
Post-treatment 1 weekend from baseline
Basic Psychological Needs Satisfaction Scale - General
Time Frame: Post-treatment 1 weekend from baseline
In the relaxation program group. Satisfaction and frustration of basic psychological needs will be assessed using the Basic Psychological Needs Satisfaction in General Scale. This self-report scale includes 16 items and evaluates three fundamental psychological needs: autonomy, competence, and relatedness. Each item is scored on a Likert-type scale ranging from 1 to 7, where 1 indicates "totally disagree" and 7 indicates "totally agree". Participants select the response that best reflects their perceived satisfaction or frustration regarding these psychological needs. Item scores are summed to obtain a total score. Higher scores indicate greater satisfaction of basic psychological needs and therefore a better outcome. The Spanish validation of the 16-item version has shown adequate psychometric properties.
Post-treatment 1 weekend from baseline
Basic Psychological Needs Satisfaction Scale - General
Time Frame: Three months follow up
In the compassion program group. Satisfaction and frustration of basic psychological needs will be assessed using the Basic Psychological Needs Satisfaction in General Scale. This self-report scale includes 16 items and evaluates three fundamental psychological needs: autonomy, competence, and relatedness. Each item is scored on a Likert-type scale ranging from 1 to 7, where 1 indicates "totally disagree" and 7 indicates "totally agree". Participants select the response that best reflects their perceived satisfaction or frustration regarding these psychological needs. Item scores are summed to obtain a total score. Higher scores indicate greater satisfaction of basic psychological needs and therefore a better outcome. The Spanish validation of the 16-item version has shown adequate psychometric properties.
Three months follow up
Basic Psychological Needs Satisfaction Scale - General
Time Frame: Three months follow up
In the relaxation program group. Satisfaction and frustration of basic psychological needs will be assessed using the Basic Psychological Needs Satisfaction in General Scale. This self-report scale includes 16 items and evaluates three fundamental psychological needs: autonomy, competence, and relatedness. Each item is scored on a Likert-type scale ranging from 1 to 7, where 1 indicates "totally disagree" and 7 indicates "totally agree". Participants select the response that best reflects their perceived satisfaction or frustration regarding these psychological needs. Item scores are summed to obtain a total score. Higher scores indicate greater satisfaction of basic psychological needs and therefore a better outcome. The Spanish validation of the 16-item version has shown adequate psychometric properties.
Three months follow up
Treatment Received Satisfaction Scale
Time Frame: Baseline
In the compassion program group. Satisfaction with the treatment received will be assessed using the Treatment Received Satisfaction Scale. This self-report scale includes 4 items designed to evaluate whether participants are satisfied with the intervention received and whether they perceive it as effective. Items 1 and 2 are answered using five response options, while items 3 and 4 are answered using four response options. The scale provides three specific components: satisfaction, problem resolution, and perceived emotional change. A global score is calculated from these components according to the formula proposed by the authors. The global score ranges from 0 to 300, with higher scores indicating greater perceived treatment effectiveness and therefore a better outcome.
Baseline
Treatment Received Satisfaction Scale
Time Frame: baseline
In the relaxation program group. Satisfaction with the treatment received will be assessed using the Treatment Received Satisfaction Scale. This self-report scale includes 4 items designed to evaluate whether participants are satisfied with the intervention received and whether they perceive it as effective. Items 1 and 2 are answered using five response options, while items 3 and 4 are answered using four response options. The scale provides three specific components: satisfaction, problem resolution, and perceived emotional change. A global score is calculated from these components according to the formula proposed by the authors. The global score ranges from 0 to 300, with higher scores indicating greater perceived treatment effectiveness and therefore a better outcome.
baseline
Treatment Received Satisfaction Scale
Time Frame: Post-treatment 1 weekend from baseline
In the compassion program group. Satisfaction with the treatment received will be assessed using the Treatment Received Satisfaction Scale. This self-report scale includes 4 items designed to evaluate whether participants are satisfied with the intervention received and whether they perceive it as effective. Items 1 and 2 are answered using five response options, while items 3 and 4 are answered using four response options. The scale provides three specific components: satisfaction, problem resolution, and perceived emotional change. A global score is calculated from these components according to the formula proposed by the authors. The global score ranges from 0 to 300, with higher scores indicating greater perceived treatment effectiveness and therefore a better outcome.
Post-treatment 1 weekend from baseline
Treatment Received Satisfaction Scale
Time Frame: Post-treatment 1 weekend from baseline
In the relaxation program group. Satisfaction with the treatment received will be assessed using the Treatment Received Satisfaction Scale. This self-report scale includes 4 items designed to evaluate whether participants are satisfied with the intervention received and whether they perceive it as effective. Items 1 and 2 are answered using five response options, while items 3 and 4 are answered using four response options. The scale provides three specific components: satisfaction, problem resolution, and perceived emotional change. A global score is calculated from these components according to the formula proposed by the authors. The global score ranges from 0 to 300, with higher scores indicating greater perceived treatment effectiveness and therefore a better outcome.
Post-treatment 1 weekend from baseline
Treatment Received Satisfaction Scale
Time Frame: Three-months follow-up]
In the compassion program group. Satisfaction with the treatment received will be assessed using the Treatment Received Satisfaction Scale. This self-report scale includes 4 items designed to evaluate whether participants are satisfied with the intervention received and whether they perceive it as effective. Items 1 and 2 are answered using five response options, while items 3 and 4 are answered using four response options. The scale provides three specific components: satisfaction, problem resolution, and perceived emotional change. A global score is calculated from these components according to the formula proposed by the authors. The global score ranges from 0 to 300, with higher scores indicating greater perceived treatment effectiveness and therefore a better outcome.
Three-months follow-up]
Treatment Received Satisfaction Scale
Time Frame: Three-months follow-up]
In the relaxation program group. Satisfaction with the treatment received will be assessed using the Treatment Received Satisfaction Scale. This self-report scale includes 4 items designed to evaluate whether participants are satisfied with the intervention received and whether they perceive it as effective. Items 1 and 2 are answered using five response options, while items 3 and 4 are answered using four response options. The scale provides three specific components: satisfaction, problem resolution, and perceived emotional change. A global score is calculated from these components according to the formula proposed by the authors. The global score ranges from 0 to 300, with higher scores indicating greater perceived treatment effectiveness and therefore a better outcome.
Three-months follow-up]
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Time Frame: Baseline
In the compassion program group. Sensory processing sensitivity will be assessed using the Reduced Highly Sensitive Person Scale to the Adult Spanish Population. This self-report scale includes 16 items designed to evaluate sensitivity in Spanish-speaking adults and to explore how sensitivity may influence different aspects of daily life and psychological well-being. Each item is scored on a Likert-type scale ranging from 0 to 7, where 0 indicates "totally disagree" and 7 indicates "totally agree". Participants select the response that best reflects their experience. Item scores are summed and divided by the number of items to obtain the final score. Higher scores indicate greater sensory processing sensitivity.
Baseline
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Time Frame: baseline
In the relaxation program group. Sensory processing sensitivity will be assessed using the Reduced Highly Sensitive Person Scale to the Adult Spanish Population. This self-report scale includes 16 items designed to evaluate sensitivity in Spanish-speaking adults and to explore how sensitivity may influence different aspects of daily life and psychological well-being. Each item is scored on a Likert-type scale ranging from 0 to 7, where 0 indicates "totally disagree" and 7 indicates "totally agree". Participants select the response that best reflects their experience. Item scores are summed and divided by the number of items to obtain the final score. Higher scores indicate greater sensory processing sensitivity.
baseline
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Time Frame: Post-treatment 1 weekend from baseline
In the compassion program group. Sensory processing sensitivity will be assessed using the Reduced Highly Sensitive Person Scale to the Adult Spanish Population. This self-report scale includes 16 items designed to evaluate sensitivity in Spanish-speaking adults and to explore how sensitivity may influence different aspects of daily life and psychological well-being. Each item is scored on a Likert-type scale ranging from 0 to 7, where 0 indicates "totally disagree" and 7 indicates "totally agree". Participants select the response that best reflects their experience. Item scores are summed and divided by the number of items to obtain the final score. Higher scores indicate greater sensory processing sensitivity.
Post-treatment 1 weekend from baseline
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Time Frame: Post-treatment 1 weekend from baseline
In the relaxation program group. Sensory processing sensitivity will be assessed using the Reduced Highly Sensitive Person Scale to the Adult Spanish Population. This self-report scale includes 16 items designed to evaluate sensitivity in Spanish-speaking adults and to explore how sensitivity may influence different aspects of daily life and psychological well-being. Each item is scored on a Likert-type scale ranging from 0 to 7, where 0 indicates "totally disagree" and 7 indicates "totally agree". Participants select the response that best reflects their experience. Item scores are summed and divided by the number of items to obtain the final score. Higher scores indicate greater sensory processing sensitivity.
Post-treatment 1 weekend from baseline
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Time Frame: Three-months follow-up]
In the compassion program group. Sensory processing sensitivity will be assessed using the Reduced Highly Sensitive Person Scale to the Adult Spanish Population. This self-report scale includes 16 items designed to evaluate sensitivity in Spanish-speaking adults and to explore how sensitivity may influence different aspects of daily life and psychological well-being. Each item is scored on a Likert-type scale ranging from 0 to 7, where 0 indicates "totally disagree" and 7 indicates "totally agree". Participants select the response that best reflects their experience. Item scores are summed and divided by the number of items to obtain the final score. Higher scores indicate greater sensory processing sensitivity.
Three-months follow-up]
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Time Frame: Three-months follow-up]
In the relaxation program group. Sensory processing sensitivity will be assessed using the Reduced Highly Sensitive Person Scale to the Adult Spanish Population. This self-report scale includes 16 items designed to evaluate sensitivity in Spanish-speaking adults and to explore how sensitivity may influence different aspects of daily life and psychological well-being. Each item is scored on a Likert-type scale ranging from 0 to 7, where 0 indicates "totally disagree" and 7 indicates "totally agree". Participants select the response that best reflects their experience. Item scores are summed and divided by the number of items to obtain the final score. Higher scores indicate greater sensory processing sensitivity.
Three-months follow-up]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 22, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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