Implementing Online Mental Health Program
IM-MIND-SAS
A Hybrid Type 3 Effectiveness-implementation Trial of an Online Psychotherapy Program for Mental Health Prevention Among Healthcare Professionals in the Andalusian Health System
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2025
CompletedFirst Posted
Study publicly available on registry
July 15, 2025
CompletedStudy Start
First participant enrolled
November 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
July 15, 2025
July 1, 2025
1.7 years
July 4, 2025
July 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility of Intervention Measure (FIM)
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
Post-treatment 10 weeks from baseline
System Usability Scale (SUS)
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
Post-treatment, 10 weeks from baseline
Client Satisfaction Questionnaire adapted to Internet-Based interventions (CSQ-I)
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.
Post-treatment 10 weeks from baseline
Secondary Outcomes (6)
Perceived Stress Scale (PSS)
Baseline
Perceived Stress Scale (PSS)
Post-treatment 10 weeks from baseline
Patient Health Questionnaire (PHQ-9)
Baseline
Patient Health Questionnaire (PHQ-9)
Post-treatment 10 weeks from baseline
General Anxiety Disorder-7 (GAD-7)
Baseline
- +1 more secondary outcomes
Study Arms (1)
MINDxYOU
EXPERIMENTALThe 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Diagnosis of serious mental illness.
- Suicidal ideation.
- Substance abuse or related disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Regional Universitario de Málaga Plaza del Hospital Civil s/n, Pabellón 4, 1ª Planta, 29009, Málaga
Málaga, 29009, Spain
Related Publications (2)
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.
PMID: 39899345RESULTLopez-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.
PMID: 36357881RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Gloria Margarita Guerrero Pertíñez, PhD
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- PRINCIPAL INVESTIGATOR
José Guzmán Parra, PhD
Hospital Regional Universitario de Málaga Plaza del Hospital Civil s/n, Pabellón 4, 1ª Planta, 29009, Málaga
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2025
First Posted
July 15, 2025
Study Start
November 1, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
July 15, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
IPD will not be shared due to ethical and privacy considerations. The data collected are sensitive mental health measures from healthcare professionals, and the protocol does not include consent for sharing individual-level data with external researchers. Only aggregated results will be made publicly available.