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

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

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).

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness
• Intervention / Treatment: Behavioral: MINDxYOU

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Department of Psychiatry. Miguel Servet University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 70.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MINDxYOU; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9)	It is a 9-item scale aimed at screening for depression in primary care and other medical settings. It assesses the frequency of depressive symptoms during the last 2 weeks using a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating higher severity of depression.	Baseline
Patient Health Questionnaire (PHQ-9)	It is a 9-item scale aimed at screening for depression in primary care and other medical settings. It assesses the frequency of depressive symptoms during the last 2 weeks using a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating higher severity of depression.	Post-treatment 10 weeks from baseline
Patient Health Questionnaire (PHQ-9)	It is a 9-item scale aimed at screening for depression in primary care and other medical settings. It assesses the frequency of depressive symptoms during the last 2 weeks using a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating higher severity of depression.	6 months follow-up from baseline
General Anxiety Disorder-7 (GAD-7)	It is a 7-item self-reported measure to assess the intensity of anxiety symptoms. It refers to the period of the past 2 weeks; each item is scored in a 4-point Likert-type scale, resulting in a total score that can range from 0 to 21, with higher values reflecting more severe anxiety symptoms.	Baseline
General Anxiety Disorder-7 (GAD-7)	It is a 7-item self-reported measure to assess the intensity of anxiety symptoms. It refers to the period of the past 2 weeks; each item is scored in a 4-point Likert-type scale, resulting in a total score that can range from 0 to 21, with higher values reflecting more severe anxiety symptoms.	Post-treatment 10 weeks from baseline
General Anxiety Disorder-7 (GAD-7)	It is a 7-item self-reported measure to assess the intensity of anxiety symptoms. It refers to the period of the past 2 weeks; each item is scored in a 4-point Likert-type scale, resulting in a total score that can range from 0 to 21, with higher values reflecting more severe anxiety symptoms.	6 months follow-up from baseline
Brief Symptoms Inventory (BSI)	It is a 18-item self-reported questionnaire designed to offer a rapid screening of symptoms of psychological disorders. Each item is scored in a 5-point Likert-type scale, reflecting on the past 7 days.	Baseline
Brief Symptoms Inventory (BSI)	It is a 18-item self-reported questionnaire designed to offer a rapid screening of symptoms of psychological disorders. Each item is scored in a 5-point Likert-type scale, reflecting on the past 7 days.	Post-treatment 10 weeks from baseline
Brief Symptoms Inventory (BSI)	It is a 18-item self-reported questionnaire designed to offer a rapid screening of symptoms of psychological disorders. Each item is scored in a 5-point Likert-type scale, reflecting on the past 7 days.	6 months follow-up from baseline
Connor-Davidson Resilience Scale (CD-RISC)	It is a 10-item self-reported measure addressed at assessing resilience. Each item is scored in a 5-point Likert scale, and the total score, which ranges from 1 to 5, is calculated by averaging the scores of the items; higher scores indicate higher levels of resilience.	Baseline
Connor-Davidson Resilience Scale (CD-RISC)	It is a 10-item self-reported measure addressed at assessing resilience. Each item is scored in a 5-point Likert scale, and the total score, which ranges from 1 to 5, is calculated by averaging the scores of the items; higher scores indicate higher levels of resilience.	Post-treatment 10 weeks from baseline
Connor-Davidson Resilience Scale (CD-RISC)	It is a 10-item self-reported measure addressed at assessing resilience. Each item is scored in a 5-point Likert scale, and the total score, which ranges from 1 to 5, is calculated by averaging the scores of the items; higher scores indicate higher levels of resilience.	6 months follow-up from baseline
Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15)	It is an adaptation of the original 39-item FFMQ, a questionnaire addressed at measuring the five facets of mindfulness. Each subscale of the FFMQ-15 includes 3 items, scored in a Likert-type scale (1-5). A score for each subscale, ranging from 5 to 15, can be computed by summing the items, where higher scores indicate higher levels of the mindfulness facet.	Baseline
Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15)	It is an adaptation of the original 39-item FFMQ, a questionnaire addressed at measuring the five facets of mindfulness. Each subscale of the FFMQ-15 includes 3 items, scored in a Likert-type scale (1-5). A score for each subscale, ranging from 5 to 15, can be computed by summing the items, where higher scores indicate higher levels of the mindfulness facet.	Post-treatment 10 weeks from baseline
Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15)	It is an adaptation of the original 39-item FFMQ, a questionnaire addressed at measuring the five facets of mindfulness. Each subscale of the FFMQ-15 includes 3 items, scored in a Likert-type scale (1-5). A score for each subscale, ranging from 5 to 15, can be computed by summing the items, where higher scores indicate higher levels of the mindfulness facet.	6 months follow-up from baseline
Sussex-Oxford Compassion Scales (SOCS)	This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Baseline
Sussex-Oxford Compassion Scales (SOCS)	This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	Post-treatment 10 weeks from baseline
Sussex-Oxford Compassion Scales (SOCS)	This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion	6 months follow-up from baseline
Acceptance and Action Questionnaire-II (AAQ-II)	It is a measure for assessing experiential avoidance, a key element of 'third wave' psychotherapies that refers to the tendency to avoid thoughts, feelings, memories, sensations and other internal experiences, and which is very commonly associated with worse mental health outcomes, as opposite to psychological flexibility. The scale presents 7 items scored in a 7-point Likert-type scale, and a total score is calculated by summing all the items. Higher scores mean higher experiential avoidance.	Baseline
Acceptance and Action Questionnaire-II (AAQ-II)	It is a measure for assessing experiential avoidance, a key element of 'third wave' psychotherapies that refers to the tendency to avoid thoughts, feelings, memories, sensations and other internal experiences, and which is very commonly associated with worse mental health outcomes, as opposite to psychological flexibility. The scale presents 7 items scored in a 7-point Likert-type scale, and a total score is calculated by summing all the items. Higher scores mean higher experiential avoidance.	Post-treatment 10 weeks from baseline
Acceptance and Action Questionnaire-II (AAQ-II)	It is a measure for assessing experiential avoidance, a key element of 'third wave' psychotherapies that refers to the tendency to avoid thoughts, feelings, memories, sensations and other internal experiences, and which is very commonly associated with worse mental health outcomes, as opposite to psychological flexibility. The scale presents 7 items scored in a 7-point Likert-type scale, and a total score is calculated by summing all the items. Higher scores mean higher experiential avoidance.	6 months follow-up from baseline
EuroQol five-dimensional classification system (EQ-5D)	It is a widely used health-related quality of life measure. First, the participant is asked to report how severe (1= no problems, 2= mild, 3= moderate, 4= severe, 5= extreme) are the problems they may present in the day of reporting regarding each of the following five domains: mobility, self-care, usual activities, pain, and anxiety/depression. The utility scores are obtained from the EQ-5D classification system and are used to rate patients' health-related quality of life, which normally range from 0 (although it is possible to present negative scores) to 1 (i.e., "perfect health").	Baseline
EuroQol five-dimensional classification system (EQ-5D)	It is a widely used health-related quality of life measure. First, the participant is asked to report how severe (1= no problems, 2= mild, 3= moderate, 4= severe, 5= extreme) are the problems they may present in the day of reporting regarding each of the following five domains: mobility, self-care, usual activities, pain, and anxiety/depression. The utility scores are obtained from the EQ-5D classification system and are used to rate patients' health-related quality of life, which normally range from 0 (although it is possible to present negative scores) to 1 (i.e., "perfect health").	6 months follow-up from baseline
Client Service Receipt Inventory (CSRI)	It is addressed at describe and measure service utilization patterns as a basis for estimating associated costs across healthcare, social care and community settings.	Baseline
Client Service Receipt Inventory (CSRI)	It is addressed at describe and measure service utilization patterns as a basis for estimating associated costs across healthcare, social care and community settings.	6 months follow-up from baseline
System Usability Scale (SUS)	It is a 10-item questionnaire to measure the usability which qualitatively is related with the quality and acceptability of the intervention. The scale presents 5-point Likert-type scale (0 = never, 1 = almost never, 2 = often, 3 = sometimes and 4 = always). A total score, ranging from 0 to 40, is calculated by totalling the scores from all the items, and higher total values indicate higher level of acceptability of the intervention	Post-treatment 10 weeks from baseline
Client Satisfaction Questionnaire adapted to Internet-Based interventions (CSQ-I)	It is an 8-item, 4-point Likert scale questionnaire that assesses the general satisfaction of the participants regarding the received intervention. The total score ranges from 8 to 32.	Post-treatment 10 weeks from baseline
Intervention Appropriateness Measure (IAM)	Includes 4 items designed to measure appropriateness of the intervention. The scale presents 5-point Likert-type scale (1 = completely disagree, 2 = in disagreement, 3 = neither agree nor disagree, 4 = agree and 5 = completely agree). A total score, ranging from 0 to 20, is calculated by totalling the scores from all the items, and higher total values indicate higher level of appropriateness of the intervention	Post-treatment 10 weeks from baseline
Attitudes towards Psychological Online Interventions (APOI)	Includes 16 items to assess attitudes toward online interventions among people with depressive symptomatology. The APOI explores four dimensions; "Skepticism and Perception of Risks", "Confidence in Effectiveness", "Technologization Threat" and "Anonymity Benefits". Each factor is calculated from the sum of 4 specific items. The scale presents 5-point Likert-type scale (1 = totally agree, 2 = agree, 3 = I'm not sure, 4 = disagree and 5 = totally disagree). Each factor can get a score between 4-20 points, and the higher the score, the greater the sensation perceived by the participant in each of the factors.	Post-treatment 10 weeks from baseline

Collaborators and Investigators

• Sponsor: Hospital Miguel Servet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Stress; Healthcare providers; Third-wave psychotherapies
• Other Study ID Numbers: PI22/341

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No