Mental Health WellnessNCT05436717
Efficacy and Implementation of MINDxYOU Program for Reducing Stress and Promote Mental Health Among Healthcare Providers
A study testing MINDxYOU in people with Mental Health Wellness, run by Hospital Miguel Servet at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness
- What is being tested?
- MINDxYOU
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Psychiatry. Miguel Servet University Hospital
Zaragoza, 50009
About this study
Official title: 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).
- Conditions
- Mental Health Wellness
- Being tested
- MINDxYOU
- Keywords
- Healthcare providers, Stress, Third-wave psychotherapies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINDxYOUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: MINDxYOU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months follow-up from baseline
Secondary outcomes (29)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Post-treatment 10 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start15 Jan 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health WellnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Garcia Campayo, Hospital Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436717
- Sponsor's protocol ID
- PI22/341
- Status last verified
- Mar 2025
- First submitted
- 22 Jun 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39899345Lopez-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.
PubMed 36357881
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Implementation of an Online Mindfulness and Compassion-based Program (MINDxYOU) for Reducing Stress and Promote Mental Health Among Healthcare Providers in Spain
- ClinicalTrials.gov ID
- NCT05436717
- Acronym / sponsor ID
- PI22/341
- Conditions
- Mental Health Wellness
- Keywords
- Healthcare providers, Stress, Third-wave psychotherapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Hospital Miguel ServetUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MINDxYOU | Experimental | Behavioral: MINDxYOUThe 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MINDxYOUThe 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. | Behavioural | MINDxYOU |
Primary outcome
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.
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.
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.
29 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline
Patient Health Questionnaire (PHQ-9)
Time frame: Post-treatment 10 weeks from baseline
Patient Health Questionnaire (PHQ-9)
Time frame: 6 months follow-up from baseline
General Anxiety Disorder-7 (GAD-7)
Time frame: Baseline
General Anxiety Disorder-7 (GAD-7)
Time frame: Post-treatment 10 weeks from baseline
General Anxiety Disorder-7 (GAD-7)
Time frame: 6 months follow-up from baseline
Brief Symptoms Inventory (BSI)
Time frame: Baseline
Brief Symptoms Inventory (BSI)
Time frame: Post-treatment 10 weeks from baseline
Brief Symptoms Inventory (BSI)
Time frame: 6 months follow-up from baseline
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Baseline
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Post-treatment 10 weeks from baseline
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: 6 months follow-up from baseline
Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15)
Time frame: Baseline
Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15)
Time frame: Post-treatment 10 weeks from baseline
Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15)
Time frame: 6 months follow-up from baseline
Sussex-Oxford Compassion Scales (SOCS)
Time frame: Baseline
Sussex-Oxford Compassion Scales (SOCS)
Time frame: Post-treatment 10 weeks from baseline
Sussex-Oxford Compassion Scales (SOCS)
Time frame: 6 months follow-up from baseline
Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: Baseline
Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: Post-treatment 10 weeks from baseline
Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: 6 months follow-up from baseline
EuroQol five-dimensional classification system (EQ-5D)
Time frame: Baseline
EuroQol five-dimensional classification system (EQ-5D)
Time frame: 6 months follow-up from baseline
Client Service Receipt Inventory (CSRI)
Time frame: Baseline
Client Service Receipt Inventory (CSRI)
Time frame: 6 months follow-up from baseline
System Usability Scale (SUS)
Time frame: Post-treatment 10 weeks from baseline
Client Satisfaction Questionnaire adapted to Internet-Based interventions (CSQ-I)
Time frame: Post-treatment 10 weeks from baseline
Intervention Appropriateness Measure (IAM)
Time frame: Post-treatment 10 weeks from baseline
Attitudes towards Psychological Online Interventions (APOI)
Time frame: Post-treatment 10 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 39899345Lopez-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.
- Derived from this study: PubMed 36357881Lopez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINDxYOU in people with Mental Health Wellness, run by Hospital Miguel Servet at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05436717, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.