- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07698379
Prevention of Burnout in Spanish Healthcare Professionals Through Attachment-Based Compassion Therapy (ABCT)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zaragoza, Spain, 50009
- Recruiting
- Miguel Servet University Hospital
-
Contact:
- Javier García Campayo, PhD
- Phone Number: +34976506578
- Email: jgarcamp@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Active healthcare professionals (physicians and nurses) of both sexes.
- Understanding of spoken and written Spanish.
- Availability of a computer and internet connection.
- 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
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
|
Baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: baseline
|
In the relaxation program group
|
baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
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
|
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
|
Three-months follow-up]
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Three-months follow-up]
|
In the relaxation program group
|
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
|
Baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: baseline
|
In the relaxation program group
|
baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
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
|
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
|
Three-months follow-up]
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Time Frame: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Time Frame: Baseline
|
In the compassion program group
|
Baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Time Frame: baseline
|
In the relaxation program group
|
baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Time Frame: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
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
|
Post-treatment 1 weekend from baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Time Frame: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Time Frame: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time Frame: Baseline
|
In the compassion program group
|
Baseline
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time Frame: baseline
|
In the relaxation program group
|
baseline
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time Frame: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
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
|
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
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Time Frame: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Time Frame: Baseline
|
In the compassion program group
|
Baseline
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Time Frame: baseline
|
In the relaxation program group
|
baseline
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Time Frame: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
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
|
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
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Time Frame: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Depression Anxiety Stress Scales - DASS-21
Time Frame: Baseline
|
In the compassion program group
|
Baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Time Frame: baseline
|
In the relaxation program group
|
baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Time Frame: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
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
|
Post-treatment 1 weekend from baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Time Frame: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Depression Anxiety Stress Scales - DASS-21
Time Frame: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Time Frame: Baseline
|
In the compassion program group
|
Baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Time Frame: baseline
|
In the relaxation program group
|
baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Time Frame: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Time Frame: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Time Frame: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Time Frame: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Basic Psychological Needs Satisfaction Scale - General
Time Frame: Baseline
|
In the compassion program group
|
Baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Time Frame: baseline
|
In the relaxation program group
|
baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Time Frame: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
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
|
Post-treatment 1 weekend from baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Time Frame: Three months follow up
|
In the compassion program group
|
Three months follow up
|
|
Basic Psychological Needs Satisfaction Scale - General
Time Frame: Three months follow up
|
In the relaxation program group
|
Three months follow up
|
|
Treatment Received Satisfaction Scale
Time Frame: Baseline
|
In the compassion program group
|
Baseline
|
|
Treatment Received Satisfaction Scale
Time Frame: baseline
|
In the relaxation program group
|
baseline
|
|
Treatment Received Satisfaction Scale
Time Frame: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Treatment Received Satisfaction Scale
Time Frame: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Treatment Received Satisfaction Scale
Time Frame: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Treatment Received Satisfaction Scale
Time Frame: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Time Frame: Baseline
|
In the compassion program group
|
Baseline
|
|
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Time Frame: baseline
|
In the relaxation program group
|
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
|
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
|
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
|
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
|
Three-months follow-up]
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11/2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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