Clinical trial NCT05436717: Efficacy and Implementation of MINDxYOU Program for Reducing Stress and Promote Mental Health Among Healthcare Providers
Official title: Efficacy and Implementation of an Online Mindfulness and Compassion-based Program (MINDxYOU) for Reducing Stress and Promote Mental Health Among Healthcare Providers in Spain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness
Keywords: Healthcare providers
Stress
Third-wave psychotherapies
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Because of the COVID-19 pandemic situation, social and health professionals constitute a population in risk of developing psychopathologies due to the high levels of stress they experience. There is consensus regarding the need of offering these professionals psychotherapeutic evidence-based interventions addressed to reducing their stress levels and promote their wellbeing; because of the current situation, it is believed that online interventions might be the best-fitted approach. The research groups that present this project have leaded a research line that has proved the efficacy of online psychotherapeutic programs in the past. In the present project, the efficacy of the MINDxYOU program will be evaluated; this is an online intervention based on mindfulness techniques, compassion, and acceptance, and that has been developed specifically for social and health professionals. In addition, in order to overcome the gap that separates the validation of interventions and their posterior implementation, this project aims to perform an implementation study in which a hybrid design will be adopted to test the impact of the program in terms of efficacy and the feasibility of the implementation. The investigators will adopt the framework proposed by Hermes. et al., inspired in Proctor's recommendations. The study will be conducted in 2 autonomous communities (Aragón and Andalucía).


Eligibility criteria: Inclusion Criteria:

* Working as a doctor, nurse, physiotherapist, psychologist, nursing assistant, ambulance technician, or being a trainee student in any health profession, or working in a nursing home.
* Aged between 18 and 70.
* Ability to understand Spanish.
* Digital literacy and access to a smartphone, tablet, or personal computer with Internet connection.
* Giving informed consent.

Exclusion Criteria:

* Presenting an illness that affects the central nervous system.
* Having a diagnosis of a severe psychiatric condition (including severe depressive disorders, suicidal tendencies, bipolar disorders, panic disorders, anxiety or stress-related disorders, obsessive-compulsive disorders, and substance-related disorders).
* Presenting a medical, infectious, or degenerative illness that is not under control.

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline
measure: Perceived Stress Scale (PSS)
timeFrame: Post-treatment 10 weeks from baseline
measure: Perceived Stress Scale (PSS)
timeFrame: 6 months follow-up from baseline
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Post-treatment 10 weeks from baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months follow-up from baseline
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Post-treatment 10 weeks from baseline
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: 6 months follow-up from baseline
measure: Brief Symptoms Inventory (BSI)
timeFrame: Baseline
measure: Brief Symptoms Inventory (BSI)
timeFrame: Post-treatment 10 weeks from baseline
measure: Brief Symptoms Inventory (BSI)
timeFrame: 6 months follow-up from baseline
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Baseline
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Post-treatment 10 weeks from baseline
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: 6 months follow-up from baseline
measure: Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15)
timeFrame: Baseline
measure: Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15)
timeFrame: Post-treatment 10 weeks from baseline
measure: Five Facets of Mindfulness Questionnaire -15 item version (FFMQ-15)
timeFrame: 6 months follow-up from baseline
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Baseline
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: Post-treatment 10 weeks from baseline
measure: Sussex-Oxford Compassion Scales (SOCS)
timeFrame: 6 months follow-up from baseline
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Baseline
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Post-treatment 10 weeks from baseline
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: 6 months follow-up from baseline
measure: EuroQol five-dimensional classification system (EQ-5D)
timeFrame: Baseline
measure: EuroQol five-dimensional classification system (EQ-5D)
timeFrame: 6 months follow-up from baseline
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Baseline
measure: Client Service Receipt Inventory (CSRI)
timeFrame: 6 months follow-up from baseline
measure: System Usability Scale (SUS)
timeFrame: Post-treatment 10 weeks from baseline
measure: Client Satisfaction Questionnaire adapted to Internet-Based interventions (CSQ-I)
timeFrame: Post-treatment 10 weeks from baseline
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Post-treatment 10 weeks from baseline
measure: Attitudes towards Psychological Online Interventions (APOI)
timeFrame: Post-treatment 10 weeks from baseline
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Department of Psychiatry. Miguel Servet University Hospital
Study officials:
References:
citation: 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.