Efficacy and Implementation of MINDxYOU Program for Reducing Stress and Promote Mental Health Among Healthcare Providers

NCT05436717 | Completed

• 1 other identifier: PI22/341
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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).

Conditions

Mental Health Wellness

Keywords

Healthcare providers; Stress; Third-wave psychotherapies

Outcome Measures

Primary Outcomes (3)

• Perceived Stress Scale (PSS)

  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.

  Baseline

• Perceived Stress Scale (PSS)

  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.

  Post-treatment 10 weeks from baseline

• Perceived Stress Scale (PSS)

  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.

  6 months follow-up from baseline

Secondary Outcomes (29)

• Patient Health Questionnaire (PHQ-9)

  Baseline

• Patient Health Questionnaire (PHQ-9)

  Post-treatment 10 weeks from baseline

• Patient Health Questionnaire (PHQ-9)

  6 months follow-up from baseline

• General Anxiety Disorder-7 (GAD-7)

  Baseline

• General Anxiety Disorder-7 (GAD-7)

  Post-treatment 10 weeks from baseline

Study Arms (1)

MINDxYOU

EXPERIMENTAL

The online program MINDxYOU is based on the principles of 'third wave' psychotherapies, such as the promotion of wellbeing through the practice of mindfulness, compassion, acceptance, and spirituality and the estimated time for completing the whole program is 8 weeks

Behavioral: MINDxYOU

Interventions

MINDxYOU BEHAVIORAL

The online program MINDxYOU is based on the principles of 'third wave' psychotherapies and it is an online program particularly addressed at healthcare providers which will both monitor and support the individual's mental health. The program is self-administered and will be delivered via the Internet and available via smartphone, tablet, and personal computer.

MINDxYOU

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 70.
• Ability to understand Spanish.
• Digital literacy and access to a smartphone, tablet, or personal computer with Internet connection.
• Giving informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Miguel Servet: lead

Study Sites (1)

Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, 50009, Spain

Location

Related Publications (2)

• Lopez-Del-Hoyo Y, Fernandez-Martinez S, Perez-Aranda A, Monreal-Bartolome A, Barcelo-Soler A, Camarero-Grados L, Armas-Landaeta C, Guzman-Parra J, Carbonell V, Campos D, Chen X, Garcia-Campayo J. Effectiveness of a Web-Based Self-Guided Intervention (MINDxYOU) for Reducing Stress and Promoting Mental Health Among Health Professionals: Results From a Stepped-Wedge Cluster Randomized Trial. J Med Internet Res. 2025 Feb 3;27:e59653. doi: 10.2196/59653.

  PMID: 39899345 DERIVED

• Lopez-Del-Hoyo Y, Fernandez-Martinez S, Perez-Aranda A, Barcelo-Soler A, Guzman-Parra J, Varela-Moreno E, Campos D, Monreal-Bartolome A, Beltran-Ruiz M, Moreno-Kustner B, Mayoral-Cleries F, Garcia-Campayo J. Effectiveness and implementation of an online intervention (MINDxYOU) for reducing stress and promote mental health among healthcare workers in Spain: a study protocol for a stepped-wedge cluster randomized trial. BMC Nurs. 2022 Nov 10;21(1):308. doi: 10.1186/s12912-022-01089-5.

  PMID: 36357881 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 29, 2022
• Study Start: January 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

ES (1)