Implementing Online Mental Health Program

NCT ID: NCT07066943

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stress Healthcare Workers Mindfulness Prevention Intervention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

MINDxYOU

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Diagnosis of serious mental illness.
2. Suicidal ideation.
3. Substance abuse or related disorders.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Miguel Servet

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gloria Margarita Guerrero Pertíñez, PhD

Role: PRINCIPAL_INVESTIGATOR

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

José Guzmán Parra, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Málaga, , Spain

Site Status

Countries

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Spain

Central Contacts

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Gloria Margarita Guerrero Pertíñez, PhD

Role: CONTACT

+34620253535

Jose Guzman Parra, PhD

Role: CONTACT

+34951290377

References

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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.

Reference Type RESULT
PMID: 39899345 (View on PubMed)

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.

Reference Type RESULT
PMID: 36357881 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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RHJ-0043-2024

Identifier Type: -

Identifier Source: org_study_id

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