跳至主要内容
临床试验/NCT07698379
NCT07698379招募中不适用

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

Hospital Miguel Servet1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
180
试验地点
1
主要终点
MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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-
  • Scheduled surgical intervention during the course of the study.

研究组 & 干预措施

Compassion condition

Experimental

one weekend group sessions, held Friday evening, Saturday morning and evening and Sunday morning

干预措施: Attachment-based compassion therapy Compassion (Behavioral)

Relaxation condition

Experimental

one weekend group sessions, held Friday evening, Saturday morning and evening and Sunday morning

干预措施: Relaxation program (Behavioral)

结局指标

主要结局

MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)

时间窗: 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.

MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)

时间窗: 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.

MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)

时间窗: 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.

MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)

时间窗: 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.

次要结局

  • Burnout Clinical Subtype Questionnaire BCSQ-12(baseline)
  • MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)(Baseline)
  • MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)(baseline)
  • MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)(Post-treatment 1 weekend from baseline)
  • MASLACH BURNOUT INVENTORY HUMAN SERVICES SURVEY (MBI-HSS)(Three-months follow-up])
  • Burnout Clinical Subtype Questionnaire BCSQ-12(Baseline)
  • Burnout Clinical Subtype Questionnaire BCSQ-12(Post-treatment 1 weekend from baseline)
  • Burnout Clinical Subtype Questionnaire BCSQ-12(Three-months follow-up])
  • Sussex-Oxford Compassion for the Self Scale (SOCS-S)(Baseline)
  • Sussex-Oxford Compassion for the Self Scale (SOCS-S)(baseline)
  • Sussex-Oxford Compassion for the Self Scale (SOCS-S)(Post-treatment 1 weekend from baseline)
  • Sussex-Oxford Compassion for the Self Scale (SOCS-S)(Three-months follow-up])
  • Sussex-Oxford Compassion for Others Scale (SOCS-O)(Baseline)
  • Sussex-Oxford Compassion for Others Scale (SOCS-O)(baseline)
  • Sussex-Oxford Compassion for Others Scale (SOCS-O)(Post-treatment 1 weekend from baseline)
  • Sussex-Oxford Compassion for Others Scale (SOCS-O)(Three-months follow-up])
  • Depression Anxiety Stress Scales - DASS-21(Baseline)
  • Depression Anxiety Stress Scales - DASS-21(baseline)
  • Depression Anxiety Stress Scales - DASS-21(Post-treatment 1 weekend from baseline)
  • Depression Anxiety Stress Scales - DASS-21(Three-months follow-up])
  • FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ(Baseline)
  • FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ(baseline)
  • FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ(Post-treatment 1 weekend from baseline)
  • FIVE FACETS MINDFULNESS QUESTIONNAIRE FFMQ(Three-months follow-up])
  • Basic Psychological Needs Satisfaction Scale - General(Baseline)
  • Basic Psychological Needs Satisfaction Scale - General(baseline)
  • Basic Psychological Needs Satisfaction Scale - General(Post-treatment 1 weekend from baseline)
  • Basic Psychological Needs Satisfaction Scale - General(Three months follow up)
  • Treatment Received Satisfaction Scale(Baseline)
  • Treatment Received Satisfaction Scale(baseline)
  • Treatment Received Satisfaction Scale(Post-treatment 1 weekend from baseline)
  • Treatment Received Satisfaction Scale(Three-months follow-up])
  • Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)(Baseline)
  • Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)(baseline)
  • Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)(Post-treatment 1 weekend from baseline)
  • Reduced scale Highly Sensitive Person Scale to the Adult Spanish Population (RHSP)(Three-months follow-up])

研究者

发起方
Hospital Miguel Servet
申办方类型
Other
责任方
Principal Investigator
主要研究者

Javier Garcia Campayo

Principal Investigator

Hospital Miguel Servet

研究点 (1)

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