- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Zaragoza, Spanien, 50009
- Rekruttering
- Miguel Servet University Hospital
-
Kontakt:
- Javier García Campayo, PhD
- Telefonnummer: +34976506578
- E-mail: jgarcamp@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Tidsramme: Baseline
|
In the compassion program group
|
Baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Tidsramme: baseline
|
In the relaxation program group
|
baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Tidsramme: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Tidsramme: Baseline
|
In the compassion program group
|
Baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Tidsramme: baseline
|
In the relaxation program group
|
baseline
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)
Tidsramme: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Tidsramme: Baseline
|
In the compassion program group
|
Baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Tidsramme: baseline
|
In the relaxation program group
|
baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Tidsramme: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Tidsramme: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Tidsramme: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Burnout Clinical Subtype Questionnaire BCSQ-12
Tidsramme: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Tidsramme: Baseline
|
In the compassion program group
|
Baseline
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Tidsramme: baseline
|
In the relaxation program group
|
baseline
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for the Self Scale (SOCS-S)
Tidsramme: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Tidsramme: Baseline
|
In the compassion program group
|
Baseline
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Tidsramme: baseline
|
In the relaxation program group
|
baseline
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Sussex-Oxford Compassion for Others Scale (SOCS-O)
Tidsramme: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Depression Anxiety Stress Scales - DASS-21
Tidsramme: Baseline
|
In the compassion program group
|
Baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Tidsramme: baseline
|
In the relaxation program group
|
baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Tidsramme: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Tidsramme: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Depression Anxiety Stress Scales - DASS-21
Tidsramme: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Depression Anxiety Stress Scales - DASS-21
Tidsramme: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Tidsramme: Baseline
|
In the compassion program group
|
Baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Tidsramme: baseline
|
In the relaxation program group
|
baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Tidsramme: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Tidsramme: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Tidsramme: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ
Tidsramme: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
|
Basic Psychological Needs Satisfaction Scale - General
Tidsramme: Baseline
|
In the compassion program group
|
Baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Tidsramme: baseline
|
In the relaxation program group
|
baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Tidsramme: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Tidsramme: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Basic Psychological Needs Satisfaction Scale - General
Tidsramme: Three months follow up
|
In the compassion program group
|
Three months follow up
|
|
Basic Psychological Needs Satisfaction Scale - General
Tidsramme: Three months follow up
|
In the relaxation program group
|
Three months follow up
|
|
Treatment Received Satisfaction Scale
Tidsramme: Baseline
|
In the compassion program group
|
Baseline
|
|
Treatment Received Satisfaction Scale
Tidsramme: baseline
|
In the relaxation program group
|
baseline
|
|
Treatment Received Satisfaction Scale
Tidsramme: Post-treatment 1 weekend from baseline
|
In the compassion program group
|
Post-treatment 1 weekend from baseline
|
|
Treatment Received Satisfaction Scale
Tidsramme: Post-treatment 1 weekend from baseline
|
In the relaxation program group
|
Post-treatment 1 weekend from baseline
|
|
Treatment Received Satisfaction Scale
Tidsramme: Three-months follow-up]
|
In the compassion program group
|
Three-months follow-up]
|
|
Treatment Received Satisfaction Scale
Tidsramme: 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)
Tidsramme: Baseline
|
In the compassion program group
|
Baseline
|
|
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Tidsramme: baseline
|
In the relaxation program group
|
baseline
|
|
Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Three-months follow-up]
|
In the relaxation program group
|
Three-months follow-up]
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
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