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

Carlos Quiñonez-Freire; M Dolores Vara; Rocío Herrero; Adriana Mira; Azucena García-Palacios; Cristina Botella; Rosa M Baños

doi:10.1016/j.invent.2020.100352

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

Internet Interv. 2020 Nov 28:23:100352. doi: 10.1016/j.invent.2020.100352. eCollection 2021 Mar.

Authors

Carlos Quiñonez-Freire^{1

2}, M Dolores Vara^{1

3

4}, Rocío Herrero^{1

3

4}, Adriana Mira¹, Azucena García-Palacios^{3

5}, Cristina Botella^{3

5}, Rosa M Baños^{1

3

4}

Affiliations

¹ Department of Personality, Evaluation and Psychological Treatments, University of Valencia, Valencia, Spain.
² Mental Health Unit, Hospital Dr, Gustavo Dominguez Z, Santo Domingo, Ecuador.
³ CIBER Pathophysiology of Obesity and Nutrition (CB06/03), Carlos III Institute of Health, Madrid, Spain.
⁴ Polibienestar Research Institute, University of Valencia, Valencia, Spain.
⁵ Department of Basic Psychology, Clinical and Psychobiology, Jaume I University, Castellón, Spain.

Abstract

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 Smiling is Fun (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.

Keywords: APOI, Attitudes Towards Psychological Online Interventions; AQoL-6D, Assessment of Quality of Life 6 Dimensions; BDI-II, Beck Depression Inventory-II; CEQ, Credibility and Expectancy Questionnaire; CONSORT, Consolidated Standards of Reporting Trials; CRQ, Cultural Relevance Questionnaire; CSQ, Client Satisfaction Questionnaire; Cultural adaptation; Depression; E-SF, Ecuadorian Cultural Version of Smiling is Fun; EBPTs, Evidence-Based Psychological Treatments; GAD-7, Generalized Anxiety Disorder-7; IBIs, Internet-Based Interventions; ICD-10, International Classification of Diseases-10; ICERs, Incremental Cost-Effectiveness Ratios; Internet-based intervention; Latin America; M.I.N.I. 5.0, MINI International Neuropsychiatric Interview 5.0; MCAR, Missing Completely at Random; OASIS, Overall Anxiety Severity and Impairment Scale; ODSIS, Overall Depression Severity and Impairment Scale; PANAS, Positive and Negative Affect Schedule; PC, Primary Care; PHC, Public Health Care; PHQ-9, Patient Health Questionnaire-9; Public Health Care; QALYs, Quality-Adjusted Life-Years; RCI, Reliable Change Index; RCT, Randomized Control Trial; Randomized Controlled Trial; SPIRIT, Recommendations for Interventional Trials; SUS, System Usability Scale; TiC-P, Trimbos/iMTA Questionnaire on Costs on Psychiatric Illnesses; WAI-TECH-SF, Working Alliance Inventory for Online Intervention-Short Form; WL, Waiting List.