- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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-
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Zaragoza, Španělsko, 50009
- Nábor
- Miguel Servet University Hospital
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Kontakt:
- Javier García Campayo, PhD
- Telefonní číslo: +34976506578
- E-mail: jgarcamp@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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 |
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Experimentální: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Časové okno: Baseline
|
In the compassion program group
|
Baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Časové okno: baseline
|
In the relaxation program group
|
baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Časové okno: 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)
Časové okno: 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)
Časové okno: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Časové okno: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Časové okno: Baseline
|
In the compassion program group
|
Baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Časové okno: baseline
|
In the relaxation program group
|
baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Časové okno: 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)
Časové okno: 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)
Časové okno: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Časové okno: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Časové okno: Baseline
|
In the compassion program group
|
Baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Časové okno: baseline
|
In the relaxation program group
|
baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Časové okno: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Časové okno: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Časové okno: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Časové okno: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Časové okno: Baseline
|
In the compassion program group
|
Baseline
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Časové okno: baseline
|
In the relaxation program group
|
baseline
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Časové okno: 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)
Časové okno: 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)
Časové okno: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Časové okno: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Časové okno: Baseline
|
In the compassion program group
|
Baseline
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Časové okno: baseline
|
In the relaxation program group
|
baseline
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Časové okno: 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)
Časové okno: 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)
Časové okno: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Časové okno: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Depression Anxiety Stress Scales - DASS-21
Časové okno: Baseline
|
In the compassion program group
|
Baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Časové okno: baseline
|
In the relaxation program group
|
baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Časové okno: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Časové okno: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Časové okno: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Depression Anxiety Stress Scales - DASS-21
Časové okno: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Časové okno: Baseline
|
In the compassion program group
|
Baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Časové okno: baseline
|
In the relaxation program group
|
baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Časové okno: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Časové okno: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Časové okno: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Časové okno: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Basic Psychological Needs Satisfaction Scale - General
Časové okno: Baseline
|
In the compassion program group
|
Baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Časové okno: baseline
|
In the relaxation program group
|
baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Časové okno: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Časové okno: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Časové okno: Three months follow up
|
In the compassion program group
|
Three months follow up
|
|
Basic Psychological Needs Satisfaction Scale - General
Časové okno: Three months follow up
|
In the relaxation program group
|
Three months follow up
|
|
Treatment Received Satisfaction Scale
Časové okno: Baseline
|
In the compassion program group
|
Baseline
|
|
Treatment Received Satisfaction Scale
Časové okno: baseline
|
In the relaxation program group
|
baseline
|
|
Treatment Received Satisfaction Scale
Časové okno: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Treatment Received Satisfaction Scale
Časové okno: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Treatment Received Satisfaction Scale
Časové okno: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Treatment Received Satisfaction Scale
Časové okno: 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)
Časové okno: Baseline
|
In the compassion program group
|
Baseline
|
|
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Časové okno: baseline
|
In the relaxation program group
|
baseline
|
|
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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