- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Zaragoza, Spagna, 50009
- Reclutamento
- Miguel Servet University Hospital
-
Contatto:
- Javier García Campayo, PhD
- Numero di telefono: +34976506578
- Email: jgarcamp@gmail.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Lasso di tempo: Baseline
|
In the compassion program group
|
Baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Lasso di tempo: baseline
|
In the relaxation program group
|
baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Lasso di tempo: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Lasso di tempo: Baseline
|
In the compassion program group
|
Baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Lasso di tempo: baseline
|
In the relaxation program group
|
baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Lasso di tempo: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Lasso di tempo: Baseline
|
In the compassion program group
|
Baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Lasso di tempo: baseline
|
In the relaxation program group
|
baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Lasso di tempo: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Lasso di tempo: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Lasso di tempo: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Lasso di tempo: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Lasso di tempo: Baseline
|
In the compassion program group
|
Baseline
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Lasso di tempo: baseline
|
In the relaxation program group
|
baseline
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Lasso di tempo: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Lasso di tempo: Baseline
|
In the compassion program group
|
Baseline
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Lasso di tempo: baseline
|
In the relaxation program group
|
baseline
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Lasso di tempo: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Depression Anxiety Stress Scales - DASS-21
Lasso di tempo: Baseline
|
In the compassion program group
|
Baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Lasso di tempo: baseline
|
In the relaxation program group
|
baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Lasso di tempo: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Lasso di tempo: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Lasso di tempo: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Depression Anxiety Stress Scales - DASS-21
Lasso di tempo: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Lasso di tempo: Baseline
|
In the compassion program group
|
Baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Lasso di tempo: baseline
|
In the relaxation program group
|
baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Lasso di tempo: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Lasso di tempo: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Lasso di tempo: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Lasso di tempo: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Basic Psychological Needs Satisfaction Scale - General
Lasso di tempo: Baseline
|
In the compassion program group
|
Baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Lasso di tempo: baseline
|
In the relaxation program group
|
baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Lasso di tempo: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Lasso di tempo: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Lasso di tempo: Three months follow up
|
In the compassion program group
|
Three months follow up
|
|
Basic Psychological Needs Satisfaction Scale - General
Lasso di tempo: Three months follow up
|
In the relaxation program group
|
Three months follow up
|
|
Treatment Received Satisfaction Scale
Lasso di tempo: Baseline
|
In the compassion program group
|
Baseline
|
|
Treatment Received Satisfaction Scale
Lasso di tempo: baseline
|
In the relaxation program group
|
baseline
|
|
Treatment Received Satisfaction Scale
Lasso di tempo: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Treatment Received Satisfaction Scale
Lasso di tempo: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Treatment Received Satisfaction Scale
Lasso di tempo: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Treatment Received Satisfaction Scale
Lasso di tempo: 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)
Lasso di tempo: Baseline
|
In the compassion program group
|
Baseline
|
|
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Lasso di tempo: baseline
|
In the relaxation program group
|
baseline
|
|
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 11/2026
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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