Implementing Online Mental Health Program

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Feasibility of Intervention Measure (FIM) [Срок оценки: Post-treatment 10 weeks from baseline]
• System Usability Scale (SUS) [Срок оценки: Post-treatment, 10 weeks from baseline]
• Client Satisfaction Questionnaire adapted to Internet-Based interventions (CSQ-I) [Срок оценки: Post-treatment 10 weeks from baseline]

Вторичные конечные точки (6)

• Perceived Stress Scale (PSS) [Срок оценки: Baseline]
• Perceived Stress Scale (PSS) [Срок оценки: Post-treatment 10 weeks from baseline]
• Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline]
• Patient Health Questionnaire (PHQ-9) [Срок оценки: Post-treatment 10 weeks from baseline]
• General Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline]
• General Anxiety Disorder-7 (GAD-7) [Срок оценки: Post-treatment 10 weeks from baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Hospital Regional Universitario de Málaga Plaza del Hospital Civil s/n, Pabellón 4, 1ª Pla — Málaga

Публикации

• 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 In PMID 39899345
• 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 clus PMID 36357881

Идентификаторы

NCT: NCT07066943 · RHJ-0043-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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