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

University of Valencia

Status: Unknown

Conditions: Depression

Treatments: Behavioral: Smiling is fun

Study type: Interventional

Funder types: Other

Identifiers

NCT04237714

00016-UV-E-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 153 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to understand and read Spanish and access to Internet and having an email address
• Access to a computer or smart phone with internet at home
• Criteria for diagnosis of depression disorder according to the MINI interview and score between 5 to 9 (mild) 10 to 14 (moderate) and 15 to 19 (Moderate/severe) on PHQ-9

Exclusion criteria

• Scores 20-27 (severe depression) on PHQ-9
• Suicidal risk
• Severe psychiatric disorders (schizophrenia, substance dependence, bipolar disorder, psychotic illness)
• Receiving psychological treatment for depression at the time of recruitment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 3 patient groups

IBI-based automated support

Experimental group

Description:

Internet-based intervention with automated support by the system. It consistes in phone text messages twice a week for users. The content of the messages focuses on motivating and reminding users to complete the activities proposed in the program and reviewing the treatment contents. Additionally an automatic email is send if participants have not access the program for a week. The program also provides continuous feedback to users through transversal tools.

Treatment:

Behavioral: Smiling is fun

IBI-plus human support

Experimental group

Description:

In this condition, the participants receive automated support explained above and additionally human support for a maximum of 5 minutes that consist in a weekly phone call provided by a psychologist. The content of phone calls is related with resolve questions or doubts about the use and clinical content of the IBI and also motivating and reminding the importance to complete activities in the program.

Treatment:

Behavioral: Smiling is fun

Control group

No Intervention group

Description:

Waiting list control group.