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NCT Number: NCT07066943

Implementing Online Mental Health Program

This study evaluates the feasibility, acceptability, and sustainability of MINDxYOU, a self-guided online psychotherapy program designed to reduce stress and improve the mental well-being of healthcare professionals in the Andalusian public health system. The trial uses a hybrid type 3 effectiveness-implementation design, combining the evaluation of implementation outcomes with observation of clinical effects on stress, anxiety, and depression. The intervention includes mindfulness, compassion, and acceptance-based practices delivered in four online modules over eight weeks. The study will be conducted in two phases: an initial hospital-based pilot and a broader rollout across primary care and hospital centers. Results will help identify how digital mental health interventions can be integrated into routine healthcare settings to support professionals working under high stress.

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Key information

Conditions

Stress Healthcare Workers Mindfulness Prevention Intervention

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Regional Universitario de Málaga Plaza del Hospital Civil s/n, Pabellón 4, 1ª Planta, 29009, Málaga

Málaga, 29009, Spain

Location contact

Gloria Margarita Guerrero Pertíñez, PhD

SUB_INVESTIGATOR

About this study

Healthcare professionals are at risk of developing mental health disorders due to the high levels of stress they experience. Therefore, it is essential to provide evidence-based psychotherapeutic interventions aimed at reducing their stress and improving their well-being. This study presents a type III hybrid effectiveness-implementation trial that evaluates the feasibility, acceptability, and sustainability of MINDxYOU, an online psychotherapy program designed for healthcare workers. In response to the growing demand for accessible and effective psychological interventions for this population, the study aims to test an implementation strategy that facilitates the integration of an evidence-based intervention into routine clinical practice.

The current research uses a type III hybrid design that focuses on evaluating implementation strategies in real-world settings, assessing how the intervention is implemented while simultaneously collecting data on its clinical effectiveness. The study will be conducted in two phases. Phase 1 will consist of a pilot in a hospital setting, and Phase 2 will extend the implementation to the Andalusian Health Service (SAS). Participants will include healthcare professionals who provide direct patient care in hospitals or primary care centers. The implementation study will analyze feasibility, acceptability, and sustainability.

The study will involve health and social care centers, including hospitals and primary care units. The primary outcomes will be implementation-related metrics, while clinical outcomes associated with the intervention will be examined as secondary outcomes.

This implementation study will be useful in establishing a framework for addressing barriers and promoting facilitators that affect the feasibility, acceptability, and sustainability of online interventions. The ultimate goal is to help close the gap between research and clinical practice, which would contribute to reducing the high levels of stress experienced by healthcare professionals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being a current healthcare professional.
  • Age between 18 and 70 years.
  • Ability to understand Spanish.
  • Digital literacy and access to a smartphone, tablet or computer with internet connection.
  • Continuity in the same workplace for at least 6 months (6) signing the informed consent to participate in the study.

Exclusion criteria

  • Diagnosis of serious mental illness.
  • Suicidal ideation.
  • Substance abuse or related disorders.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Intervention Measure (FIM)

    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 Feasibility of the intervention

  2. 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

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gloria Margarita Guerrero Pertíñez, PhD

CONTACT

[email protected]

+34620253535

Jose Guzman Parra, PhD

CONTACT

[email protected]

+34951290377

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Other

Collaborators

  • Hospital Miguel Servet

Registry information

Official study title

A Hybrid Type 3 Effectiveness-implementation Trial of an Online Psychotherapy Program for Mental Health Prevention Among Healthcare Professionals in the Andalusian Health System

Acronym: IM-MIND-SAS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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