NCT04237714

Internet-based Intervention Culturally Adapted for Treatment of Depression in the Ecuadorian Population

Cultural Adaptation of the Smile is Fun Program for the Treatment of Depression in the Ecuadorian Public Health Care System: A Study Protocol for a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Internet-Based Interventions are increasingly relevant as an alternative for reducing the gap in treatment of metal disorders such as depression, especially in resource-limited regions. In this study the investigators will try to evaluate the effectiveness of an Internet-Based Intervention culturally adapted to the Ecuadorian population for treatment of depression.

Detailed description

Our participants will be randomized to one of the following three conditions: 1) Internet-Based intervention (IBI) with automated support (e.g. e-mails or text messages), 2) IBI plus human support by phone calls (automated + human support), 3) Waiting list control group . The corresponding evaluations of the outcomes will be carried out at different moments of the process: baseline, three, six and twelve months. This study will use the Smile is Fun program for the treatment of depression previously adapted to the Ecuadorian context.

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Smiling is fun	Smile is Fun is a self-applied program that combines elements of prevention and psychological treatment for emotional disorders. It is delivered via the Internet and it is based on CBT technics. The program consists of 8 therapeutic modules and includes 3 transversal tools (activity report, calendar, how am I?) to provide feedback and accompany patients during the intervention. The program requires 8 to 10 weeks to complete in its entirety. The intervention, initially developed in Spain, will be adapted to the Ecuadorian culture including elements of the local population, such as, dialect, personal stories, examples and activities. The Ecuadorian version will be evaluate by health professional and users of public health system of Ecuador.

Timeline

• Start date: 2020-10-10
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-01-23
• Last updated: 2021-06-02

Locations

1 site across 1 country: Ecuador