Cultural adaptation of the ing program for the treatment of depression in the Ecuadorian public health care system: A study protocol for a randomized controlled trial.

BACKGROUND

Depression is one of the world's major health problems. Due to its high prevalence, it constitutes the first cause of disability among the Americas, where only a very low percentage of the population receives the adequate evidence-based psychological treatment. Internet-Based Interventions (IBIs) are a great alternative to reduce the treatment gap for mental disorders. Although there are several studies in low-and middle-income countries proving IBIs' feasibility and acceptability, there is still little evidence of the effectiveness in diverse social and cultural contexts such as Latin America.

METHODS

Two studies will be described: Study 1 is focused on the cultural adaptation of a cognitive-behavioral IBI (Botella et al. 2012, 2015) for Ecuadorian population with depression based on the procedure by Salamanca-Sanabria et al. (2018). Study 2 describes the design of a randomized controlled trial to test the preliminary efficacy of the culturally adapted intervention in a Public Health Care setting. A total of 153 patients with mild to moderate degree of depression as assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I.) and the Patient Health Questionnaire-9 (PHQ-9) will be randomly assigned to either an IBI group using only automated support by the system; an IBI group including also minimal human support; or a waiting list group. The primary outcome (depression) and secondary outcomes (e.g., anxiety, affect, quality of life) will be collected at baseline, 3, 6 and 12 months. Mixed-model analyses with no ad hoc imputations will be conducted.

DISCUSSION

This paper is pioneering in exploring the role of an Internet-based culturally adapted intervention for depression in a public care context in Ecuador. Results obtained will offer new insights into the viability and effectiveness of digital technologies for the psychological treatment of mental illnesses in developing countries.