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Clinical Trials/NCT05436717
NCT05436717
Completed
N/A

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 Servet1 site in 1 country112 target enrollmentJanuary 15, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Health Wellness
Sponsor
Hospital Miguel Servet
Enrollment
112
Locations
1
Primary Endpoint
Perceived Stress Scale (PSS)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
January 15, 2023
End Date
December 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hospital Miguel Servet
Responsible Party
Principal Investigator
Principal Investigator

Javier Garcia Campayo

Principal Investigator

Hospital Miguel Servet

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Perceived Stress Scale (PSS)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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