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

March 28, 2025 updated by: Javier Garcia Campayo, Hospital Miguel Servet

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale (PSS)
Time Frame: 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.
Baseline
Perceived Stress Scale (PSS)
Time Frame: Post-treatment 10 weeks 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.
Post-treatment 10 weeks from baseline
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.
6 months follow-up from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline
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)
Time Frame: Post-treatment 10 weeks from baseline
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)
Time Frame: 6 months follow-up from baseline
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)
Time Frame: Baseline
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)
Time Frame: Post-treatment 10 weeks from baseline
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)
Time Frame: 6 months follow-up from baseline
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)
Time Frame: Baseline
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)
Time Frame: Post-treatment 10 weeks from baseline
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)
Time Frame: 6 months follow-up from baseline
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)
Time Frame: Baseline
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)
Time Frame: Post-treatment 10 weeks from baseline
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)
Time Frame: 6 months follow-up from baseline
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)
Time Frame: Baseline
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)
Time Frame: Post-treatment 10 weeks from baseline
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)
Time Frame: 6 months follow-up from baseline
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)
Time Frame: Baseline
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)
Time Frame: Post-treatment 10 weeks from baseline
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)
Time Frame: 6 months follow-up from baseline
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)
Time Frame: Baseline
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)
Time Frame: Post-treatment 10 weeks from baseline
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)
Time Frame: 6 months follow-up from baseline
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)
Time Frame: Baseline
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)
Time Frame: 6 months follow-up from baseline
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)
Time Frame: Baseline
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)
Time Frame: 6 months follow-up from baseline
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)
Time Frame: Post-treatment 10 weeks from baseline
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)
Time Frame: Post-treatment 10 weeks from baseline
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)
Time Frame: Post-treatment 10 weeks from baseline
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)
Time Frame: Post-treatment 10 weeks from baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Miguel Servet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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