NCT05443139

Online Multi-component Psychological Intervention for Depression, Anxiety and Well-being in 7 Countries

Well-being Online: Internet-based Self-administered Intervention to Reduce Anxiety and Depression Symptomatology: Randomized Clinical Trial in 7 Countries

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Universidad Internacional de Valencia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the effectiveness of an online Multi-component psychological intervention, that is focused on providing self-support to the population of 5 Latin American countries and 2 European Countries. The objectives of the intervention are: 1) To reduce the symptoms of anxiety and depression in the adult population, 2) To increase the levels of subjective well-being.

Detailed description

Anxiety and depression at clinically significant levels are associated with suicidal thoughts and behaviors. Furthermore, it is associated with the health-disease process in two ways: 1) variables that influence behavior, hindering people's healthy habits and promoting the development of unhealthy behaviors; 2) anxiety and depression affect the psycho physiological activation of people, which affects their immune system. Considering the damage that can occur by not addressing incipient problems of anxiety and depression, it is important to develop interventions with preventive purposes. Thus, the online modality of the intervention presented in this project can benefit a significant number of people in Mexico, Ecuador, Chile, Brazil, Peru, the Netherlands and Spain. The online modality of psychological interventions is a viable treatment alternative, especially for those people who do not have any psychological treatment within their reach. The participants will be measured at pre, middle treatment, post assessment and two follow ups of 3 and 6 months. The self-report measures will include the following Psychometrics: 1. General Anxiety Disorder with 7-items (GAD-7) 2. Center for Epidemiologic Studies Depression Scale" in its revised version (CESD-R). 3. Perceived Stress Scale (PSS-10) 4. Pittsburgh Sleep Quality scale (PSQI) 5. Action Acceptance Questionnaire II (AAQ-II) 6. The Satisfaction with Life scale 7. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) 8. Perceived Deficits Questionnaire (PDQ-5) 9. The Positive and Negative Affect Schedule (PANAS) 10. Opinion on the treatment. 11. System usability scale. 12. Client Satisfaction Questionnaire (CSQ-8S) 13. The Telehealth Usability Questionnaire (TUQ)

Conditions

• Anxiety
• Depression
• Wellbeing
• Stress

Interventions

Type	Name	Description
BEHAVIORAL	Well-being online	Multi component Intervention composed 10 sessions following a structure based on Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Positive Psychology (PP), Mindfulness and Behavioral Activation Therapy (BAT).

Timeline

• Start date: 2022-12-23
• Primary completion: 2023-12-23
• Completion: 2024-11-01
• First posted: 2022-07-05
• Last updated: 2023-01-18

Locations

8 sites across 6 countries: Brazil, Ecuador, Mexico, Netherlands, Peru, Spain