A Hybrid Type 3 Effectiveness-implementation Trial of an Online Psychotherapy Program for Mental Health Prevention Among Healthcare Professionals in the Andalusian Health System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Feasibility of Intervention Measure (FIM)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: MINDxYOU (Behavioral)
Outcomes
Primary Outcomes
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
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
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
- Perceived Stress Scale (PSS)(Post-treatment 10 weeks from baseline)
- Patient Health Questionnaire (PHQ-9)(Post-treatment 10 weeks from baseline)
- General Anxiety Disorder-7 (GAD-7)(Post-treatment 10 weeks from baseline)
- Perceived Stress Scale (PSS)(Baseline)
- Patient Health Questionnaire (PHQ-9)(Baseline)
- General Anxiety Disorder-7 (GAD-7)(Baseline)