A Hybrid Type 3 Effectiveness-implementation Trial of an Online Psychotherapy Program for Mental Health Prevention Among Healthcare Professionals in the Andalusian Health System
Phase: NA
Conditions: Stress, Healthcare Workers, Mindfulness, Prevention Intervention
Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Official Study Title: 
Protocol for a Hybrid Type III Implementation-Effectiveness Trial of an Online Psychotherapy 
Program for Preventing Mental Health Problems Among Healthcare Professionals in the 
Andalusian Health System 
ClinicalTrials.gov Identifier (NCT Number): 
NCT00000000 
Document Type: 
Study Protocol 
Document Date: 
May 29, 2025 
 
 
 
 
 
 
 
 
 
 
 

Gloria Margarita Guerrero Pertíñez, Postdoctoral Researcher, Biomedical Research Institute 
of Málaga and Platform in Nanomedicine (IBIMA Plataforma BIONAND), Mental Health 
Clinical Unit, Regional University Hospital of Málaga. 
Jose Guzmán Parra, Biomedical Research Institute of Málaga and Platform in Nanomedicine 
(IBIMA Plataforma BIONAND), Clinical Management Unit for Mental Health, Regional 
University Hospital of Málaga, Málaga, Spain. 
 
Abstract 
Background: Healthcare professionals are at high risk of developing mental health disorders 
due to the stress they experience. Therefore, it is essential to offer evidence-based 
psychotherapeutic interventions to reduce their stress and improve their well-being. This 
protocol presents a Hybrid Type III study that evaluates the feasibility, acceptability, and 
sustainability of an online psychotherapy program—MINDxYOU—targeted at healthcare 
workers. In the context of growing demand for accessible and effective psychological 
interventions for health professionals, this study aims to test an implementation strategy that 
facilitates the integration of an evidence-based intervention into routine clinical practice. 
Methods/Design: This research adopts a Hybrid Type III effectiveness-implementation 
design, primarily focusing on evaluating implementation strategies in real-world settings 
while simultaneously collecting data on clinical effectiveness. The study will be conducted in 
two phases: Phase 1: A pilot study (N=30) at the Regional University Hospital of Málaga. 
Phase 2: A larger-scale implementation (N=100) within the Andalusian Public Health System 
(SAS), targeting healthcare professionals providing direct care in hospital and primary care 
settings. Implementation outcomes to be evaluated include feasibility, acceptability, and 
sustainability. 
Discussion: This implementation study aims to provide a framework for addressing barriers 
and enhancing facilitators for the integration of online interventions into healthcare practice. 
The ultimate goal is to bridge the gap between research and clinical practice, thereby 
contributing to the reduction of stress among healthcare professionals. 
 
 
 
 
 

1. Background 
Healthcare professionals face a series of stressors inherent to the highly demanding nature 
of their work, which can negatively impact their psychological well-being and physical health. 
Stress in these professionals is associated with increased emotional exhaustion, fatigue, and 
a decline in the quality of care provided to patients. The constant pressure to make quick and 
accurate decisions, high workload, intense emotions from interacting with critically ill 
patients, and confronting death and suffering can lead to disorders such as anxiety, 
depression, and burnout. 
Despite growing awareness of the importance of supporting healthcare workers’ mental 
health, traditional stress management interventions such as face-to-face therapy are often 
inaccessible or unfeasible for these professionals, who have limited time for self-care. There 
is thus an urgent need for solutions that are not only effective but also accessible and 
adaptable to the daily realities of these workers. 
Various mindfulness-based interventions have shown effectiveness in reducing stress, but 
most require in-person participation. Digital mindfulness-based interventions—especially 
unguided ones—have gained attention for their flexibility and potential to be used 
conveniently by healthcare workers. One major challenge in psychological interventions is 
the gap between research and practice. Even when proven effective, interventions can take 
years to be implemented in real-world settings. Implementation science seeks to address this 
gap by studying barriers and facilitators to adopting new interventions in clinical 
environments. 
MINDxYOU is an online psychotherapy program that integrates strategies such as 
mindfulness, compassion, acceptance, and spirituality to improve mental health among 
healthcare professionals. While previous studies have demonstrated its efficacy under 
controlled conditions, its implementation in real clinical settings requires a thorough 
evaluation of feasibility, acceptability, and sustainability. Identifying the barriers and 
facilitators that influence its adoption and continued use is key to ensuring successful 
integration into the healthcare system. 
This study uses a Hybrid Type III design, allowing for simultaneous evaluation of 
implementation strategies and clinical outcomes. Unlike trials focused solely on efficacy, this 
approach prioritizes the analysis of factors influencing the program’s acceptability and 
sustainability within health services. Specifically, the study will assess healthcare 
professionals’ willingness to use MINDxYOU, their satisfaction with the platform, and the 
feasibility of incorporating it into daily clinical practice. 
2. Research Question and Applicability 
What is the feasibility, acceptability, and sustainability of implementing the MINDxYOU 
program in real healthcare settings, and what is its impact on reducing stress and improving 
the well-being of healthcare professionals? 

This study has high applicability in mental health, particularly in healthcare systems 
experiencing high stress levels. Its integration into public health institutions could facilitate 
access to evidence-based interventions aimed at improving the well-being of healthcare 
professionals. Moreover, its findings will help optimize the implementation of digital 
therapies, identify barriers and facilitators, and extrapolate its use to other high-stress 
sectors. Evaluating its sustainability will support broader dissemination and adaptation to 
different contexts, ensuring long-term impact. 
3. Hypotheses 
1. Primary hypothesis (implementation): Implementing the MINDxYOU program in 
healthcare settings will be feasible, acceptable, and sustainable among healthcare 
professionals. 
2. Secondary hypothesis (clinical effectiveness): Participants using the program will 
experience a significant reduction in perceived stress, anxiety, and depressive symptoms 
compared to baseline. 
3. Adherence hypothesis: Program usage and participant satisfaction will be positively 
associated with perceived ease of use and perceived effectiveness of the intervention. 
4. Barriers and facilitators hypothesis: Factors such as work overload and lack of time may 
hinder program adoption, while accessibility and the flexibility of the online format will 
facilitate its integration into the routines of healthcare professionals. 
4. Objectives 
Primary Objective: 
To evaluate the feasibility, acceptability, and sustainability of implementing the MINDxYOU 
program in real-world healthcare settings. 
Secondary Objective: 
To assess clinical outcomes of the intervention, including its effects on perceived stress, 
anxiety levels, and depression symptoms among healthcare professionals. 
5. Methodology 
5.1 Study Design 
This study will adopt a Hybrid Type III effectiveness-implementation design, which combines 
the evaluation of implementation processes with the observation of the clinical outcomes of 
the intervention. This type of design primarily focuses on implementation strategies 
(feasibility, acceptability, and sustainability), while clinical outcomes are assessed in a 
naturalistic way without randomization at the patient level (Proctor et al., 2011). 
Study phases: 

- Phase 1 – Pilot study (N=30): An initial pilot study will be conducted at the Regional 
University Hospital of Málaga with a group of healthcare professionals. The program's 
acceptability will be assessed through surveys and interviews, and its use within the clinical 
setting will be observed. - Phase 2 – Expanded study (N=100): In this phase, the program will 
be implemented at scale within the Andalusian Health Service (SAS), including a broader 
sample of healthcare professionals from hospitals and primary care centers. 
5.2 Participants 
The study sample will consist of healthcare professionals working in clinical settings 
(hospitals and primary care centers) within the Andalusian Health Service (SAS). Participants 
may include doctors, nurses, nursing assistants, social workers, physiotherapists, 
psychologists, ambulance technicians, and healthcare students. 
5.3 Inclusion and Exclusion Criteria 
Inclusion criteria: 
 (1) Being a current healthcare professional (2) Aged between 18 and 70 years (3) Ability to 
understand Spanish (4) Digital literacy and access to a smartphone, tablet, or computer with 
internet access (5) Continuity in the same workplace for at least 6 months (6) Signing the 
informed consent form 
Exclusion criteria: (1) Diagnosis of severe mental illness (2) Suicidal ideation (3) Substance 
abuse or related disorders 
5.4 Variables and Measures 
Main variables (implementation): In line with the Consolidated Framework for 
Implementation Research (CFIR), Proctor et al. (2011), and Hermes et al. (2019), this study 
will evaluate the following implementation outcomes: feasibility, acceptability, and 
sustainability. Additionally, focus groups will be conducted with key stakeholders at each 
center after the intervention (post-treatment) to qualitatively assess implementation 
domains. 
Feasibility: 
Defined as the extent to which a new treatment can be successfully used or carried out in a 
specific setting. Feasibility will be assessed through passive data collected by the online 
platform, such as frequency of use. The Feasibility of Intervention Measure (FIM) (Weiner et 
al., 2017), consisting of 4 items, will also be used. This scale has shown good psychometric 
properties with high internal consistency (α = 0.85–0.91) and test-retest reliability 
coefficients (r = 0.73–0.88). 
Acceptability: 
Defined as the perception among stakeholders that the intervention is satisfactory or useful. 
It will be assessed using: - System Usability Scale (SUS) (Bangor et al., 2008): A 10-item 
questionnaire measuring usability, qualitatively linked to intervention quality and 
acceptability. The Spanish version has demonstrated good internal consistency (α = 0.81) 

(Sevilla-González et al., 2020). - Internet-based Client Satisfaction Questionnaire (CSQ-I) 
(Boß et al., 2016): An 8-item, 4-point Likert scale questionnaire measuring overall 
satisfaction. 
Sustainability: 
Assessed through ongoing monitoring of platform usage (access and participation logs) and 
semi-structured interviews to determine the integration of the program into users' daily 
routines. 
Secondary variables (clinical): - Perceived Stress Scale (PSS) (Cohen et al., 1983): 10 items 
rated on a 5-point Likert scale assessing unpredictability, uncontrollability, and overload 
during the past month. Scores range from 0 to 40, with higher scores indicating higher 
perceived stress. The Spanish version has good psychometric properties (α = 0.81; test-retest 
reliability r = 0.77). - Patient Health Questionnaire-9 (PHQ-9) (Kroenke et al., 2001): 9-item 
self-report scale assessing severity of depressive symptoms. The Spanish version 
demonstrates comparable diagnostic validity with 88% sensitivity and specificity. 
- Generalized Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006): 7-item self-report scale 
assessing anxiety over the past two weeks. Total scores range from 0 to 21; higher scores 
indicate more severe symptoms. The Spanish version has shown good psychometric 
properties (García-Campayo et al., 2010). 
5.5 Sample Size 
For the pilot study, a sensitivity analysis was conducted using a paired samples t-test, 
assuming a moderate effect size (Cohen’s dz = 0.46), 95% confidence level (α = 0.05), and 
80% statistical power. The required sample size was determined to be N = 30. For the full 
study, the same analysis was applied with a smaller effect size (Cohen’s dz = 0.25), resulting 
in a required sample size of N = 100. 
5.6 Procedure 
Recruitment strategies will include posters and brochures in hospitals and primary care 
centers, as well as presentations in group sessions with healthcare professionals, including 
those attending occupational stress consultations. Email invitations will include a brief 
explanation of the study and a web link to the platform. Participants will be required to 
submit signed informed consent electronically. Eligibility will be verified, and those meeting 
inclusion criteria will be formally enrolled. Participants will receive a welcome email with 
platform login credentials. Instructions on how to use the platform will be provided in the 
welcome module. 
Participants will be assessed on all study variables every 8 weeks. Usability (SUS) will be 
assessed after completing Modules 1 and 4. Platform usage will be tracked (logins, completed 
modules, submitted tasks). 
5.7 Evidence-Based Program 
MINDxYOU is a self-guided online intervention based on third-wave psychotherapies, 
including mindfulness, compassion, acceptance, and spirituality. It consists of four modules 

and includes videos, readings, guided audio exercises, and downloadable resources to 
integrate practices into daily healthy habits (e.g., physical activity, sleep, diet, socialization). 
The program starts with a welcome module where participants share their stress factors and 
receive motivational feedback to encourage adherence. Each module includes explanatory 
videos, key content, and practical exercises. Participants are encouraged to complete each 
module over two weeks. Module 1 focuses on applying mindfulness and compassion to 
healthy lifestyle areas. The program lasts approximately 8 weeks. 
A recent study showed significant reductions in perceived stress among participants who 
completed at least three of the four modules. Improvements were also noted in depression, 
anxiety, somatization, resilience, self-compassion, and some mindfulness facets (López-Del-
Hoyo et al., 2025). 
6. Data Analysis 
For the implementation analysis, outcomes will be assessed following the framework by 
Hermes et al. (2019) and Proctor et al. (2011). Passive data will include objective usage 
metrics (e.g., logins, frequency of use, completed modules, tasks submitted). Quantitative 
data from questionnaires will be analyzed using appropriate statistical methods, while 
qualitative data will be gathered through stakeholder interviews. 
For the clinical analysis, variables will be described using mean and 95% confidence intervals 
for normally distributed quantitative variables, or medians and interquartile range for non-
normally distributed data. Effectiveness variables (stress, anxiety, and depression) will be 
compared using paired-samples t-tests. 
7. Ethics and Dissemination 
All procedures will follow the Declaration of Helsinki (1964 and subsequent amendments; 
latest version adopted at the 64th WMA General Assembly, Fortaleza, Brazil). Signed 
informed consent will be obtained from all participants, who will not receive any financial 
compensation. Participants will be informed about study procedures, potential risks, and 
their right to withdraw at any time. 
Major protocol modifications (e.g., changes in eligibility, outcomes, analysis) must be 
approved by ethics committees. Data confidentiality will comply with Spanish Organic Law 
3/2018 on Data Protection and Digital Rights, aligned with the EU GDPR. A specific plan will 
be implemented to ensure maximum data security, using two separate systems and 
databases: one for personal data and one for clinical data, hosted on separate servers. 
Study results will be published in peer-reviewed biomedical journals and presented at 
national and international conferences. Reporting will adhere to the StaRI (Standards for 
Reporting Implementation Studies) statement (Pinnock et al., 2017). 

8. Study Timeline 
ACTIVITY 1: Implementation Study (2025–2026) 1.1 Pilot study at Regional University 
Hospital of Málaga1.2 Implementation within the Andalusian Health Service (SAS): - 
Intervention delivery, coordination meetings with healthcare staff- Participant recruitment 
and online treatment administration- Post-treatment protocol evaluation, platform 
maintenance, technical support- Collection of acceptability and appropriateness data, focus 
groups with professionals and managers 
ACTIVITY 2: Data Analysis and Interpretation (2026–2027) - Research team meetings; 
quantitative and qualitative data analysis- Final report preparation 
ACTIVITY 3: Dissemination and Exploitation of Results (2027) - Preparation of manuscripts; 
dissemination through professional events, health agencies, social media, and media 
outreach 
9. Funding and Resources 
This project is supported by a 3-year Junior Postdoctoral contract funded by the Andalusian 
Government (CSyC 2024 – Postdoctoral Grants, Ref: RHJ-0043-2024). The study is based at 
the Research Unit of the Mental Health Clinical Management Unit at the Regional University 
Hospital of Málaga, part of the Biomedical Research Institute of Málaga (IBIMA), which 
provides the infrastructure required for conducting the research. Resources from the Mental 
Health UGC will cover costs such as software licenses. 
Personnel: Junior Postdoctoral Researcher (36 months) – €125,514Technical: Moodle license 
– €2,000 annually 
10. Study Limitations and Strengths 
This study’s strengths include its innovative implementation focus, accessible online format, 
evidence-based design, and applicability across various healthcare environments. However, 
limitations include possible low adherence, lack of a control group, variability in 
participation, and dependence on technology. Its potential integration into the public health 
system makes it a valuable resource for supporting healthcare workers’ mental health, 
reducing demand on mental health services, and improving patient care quality. 
11. Discussion 
This implementation study of the MINDxYOU program provides key insights into the 
feasibility, acceptability, and sustainability of a digital mental health intervention for 
healthcare professionals. Findings will evaluate how mindfulness-, compassion-, and 
acceptance-based strategies can be effectively integrated into real clinical settings (Bauer & 
Kirchner, 2020). 
A key strength of this study lies in its implementation science approach, addressing both 
barriers and facilitators of adoption in the Andalusian Health Service. Identifying these 
factors is essential for designing strategies that support the sustainable and scalable use of 

MINDxYOU. The Hybrid Type III design advances implementation science by simultaneously 
assessing clinical effectiveness and contextual influences (Proctor et al., 2011). 
Preliminary evidence suggests MINDxYOU can significantly reduce perceived stress and 
improve healthcare professionals’ psychological well-being (López-Del-Hoyo et al., 2025). 
However, real-world implementation may face challenges, including adherence and 
acceptance by participants. Results will be essential to evaluate the program’s feasibility in 
busy clinical workflows. 
Digital platforms for mental health gained rapid acceptance during the COVID-19 pandemic, 
representing a paradigm shift in healthcare delivery. Still, questions remain about their long-
term quality, accessibility, and effectiveness. This study includes usability and acceptability 
metrics to empirically evaluate healthcare professionals’ engagement and identify factors 
that could enhance implementation (Bangor et al., 2008). 
From a clinical perspective, results may help bridge the gap between research and care, 
supporting routine use of evidence-based interventions. Findings can inform program 
adaptations and scalability for other high-stress populations. Ultimately, improving 
healthcare workers’ mental health may also enhance patient care quality. Effective 
implementation strategies could guide future digital health interventions, benefiting both the 
workforce and the healthcare system as a whole.