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临床试验/NCT05436717
NCT05436717已完成不适用

Efficacy and Implementation of an Online Mindfulness and Compassion-based Program (MINDxYOU) for Reducing Stress and Promote Mental Health Among Healthcare Providers in Spain

Hospital Miguel Servet2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2023年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
112
试验地点
2
主要终点
Perceived Stress Scale (PSS)

研究概览

简要总结

Because of the COVID-19 pandemic situation, social and health professionals constitute a population in risk of developing psychopathologies due to the high levels of stress they experience. There is consensus regarding the need of offering these professionals psychotherapeutic evidence-based interventions addressed to reducing their stress levels and promote their wellbeing; because of the current situation, it is believed that online interventions might be the best-fitted approach. The research groups that present this project have leaded a research line that has proved the efficacy of online psychotherapeutic programs in the past. In the present project, the efficacy of the MINDxYOU program will be evaluated; this is an online intervention based on mindfulness techniques, compassion, and acceptance, and that has been developed specifically for social and health professionals. In addition, in order to overcome the gap that separates the validation of interventions and their posterior implementation, this project aims to perform an implementation study in which a hybrid design will be adopted to test the impact of the program in terms of efficacy and the feasibility of the implementation. The investigators will adopt the framework proposed by Hermes. et al., inspired in Proctor's recommendations. The study will be conducted in 2 autonomous communities (Aragón and Andalucía).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Working as a doctor, nurse, physiotherapist, psychologist, nursing assistant, ambulance technician, or being a trainee student in any health profession, or working in a nursing home.
  • Aged between 18 and
  • Ability to understand Spanish.
  • Digital literacy and access to a smartphone, tablet, or personal computer with Internet connection.
  • Giving informed consent.

排除标准

  • Presenting an illness that affects the central nervous system.
  • Having a diagnosis of a severe psychiatric condition (including severe depressive disorders, suicidal tendencies, bipolar disorders, panic disorders, anxiety or stress-related disorders, obsessive-compulsive disorders, and substance-related disorders).
  • Presenting a medical, infectious, or degenerative illness that is not under control.

结局指标

主要结局

Perceived Stress Scale (PSS)

时间窗: 6 months follow-up from baseline

Consists of 10 items in which participants are asked to rate how unpredictable, uncontrollable, and overloaded they have found their life over the past month on a 5-point Likert-type scale. Scores range from 0 to 40, and higher scores reflect higher levels of perceived stress.

次要结局

  • EuroQol five-dimensional classification system (EQ-5D)(6 months follow-up from baseline)
  • Client Satisfaction Questionnaire adapted to Internet-Based interventions (CSQ-I)(Post-treatment 10 weeks from baseline)
  • Attitudes towards Psychological Online Interventions (APOI)(Post-treatment 10 weeks from baseline)
  • General Anxiety Disorder-7 (GAD-7)(6 months follow-up from baseline)
  • Brief Symptoms Inventory (BSI)(6 months follow-up from baseline)
  • Sussex-Oxford Compassion Scales (SOCS)(6 months follow-up from baseline)
  • Patient Health Questionnaire (PHQ-9)(6 months follow-up from baseline)
  • Connor-Davidson Resilience Scale (CD-RISC)(6 months follow-up from baseline)
  • Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15)(6 months follow-up from baseline)
  • Acceptance and Action Questionnaire-II (AAQ-II)(6 months follow-up from baseline)
  • Client Service Receipt Inventory (CSRI)(6 months follow-up from baseline)
  • System Usability Scale (SUS)(Post-treatment 10 weeks from baseline)
  • Intervention Appropriateness Measure (IAM)(Post-treatment 10 weeks from baseline)

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 (2)

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