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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Smiling is fun


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI-based automated support<br>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. | Behavioral: Smiling is fun<br>* 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.<br>|
| Experimental: IBI-plus human support<br>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. | Behavioral: Smiling is fun<br>* 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.<br>|
| No Intervention: Control group<br>Waiting list control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression symptoms. Beck Depression Inventory- II (BDI-II) | It is a 21 item self-report that measure the presence of depressive symptoms in the past two weeks. Spanish version by Sanz et al., 2003. | Baseline (week 0), 3, 6 and 12 months. | 
| Change in depression symptoms. Patient Health Questionnaire (PHQ-9) | The questionnaire is composed of 9 items, it can be used as a screening test or as an evaluation instrument for depressive disorder. Spanish version by Diez-Quevedo et al., 2001. | Baseline (week 0), 3, 6 and 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder Scale (GAD-7) | It is a 7-item scale designed for symptom detection and severity analysis of generalized anxiety disorder. Spanish version by Muñoz-Navarro et al., 2017. | Baseline (week 0), 3, 6 and 12 months. | 
| Positive and Negative Affect Schedule (PANAS) | This scale consists of 2 subscales, each with 10 items that value positive and negative affects. Spanish version by Lopez-Gomez, Hervas, & Vazquez, 2015. | Baseline (week 0), post-module (weekly for 8 weeks), 3, 6 and 12 months. | 
| Overall Anxiety Severity and Impairment Scale (OASIS) | This scale has five items related with: the frequency of symptoms of anxiety, their intensity, their interference with the person's work or school life, and their interference with social life. All items are rated on a 5-point Likert scale ranging from 0 (I didn't feel anxious) to 4 (Constant anxiety). Spanish version by Osma, J et al. 2019 | post-module (weekly for 8 weeks) | 
| Overall Depression Severity and Impairment Scale ODSIS | The ODSIS includes five items related with: the frequency of symptoms of depression, their intensity, their interference with the person's work or school life, and their interference with social life. All items are rated on a 5-point Likert scale ranging from 0 (I didn't feel depression) to 4 (Constant depression). | post-module (weekly for 8 weeks) | 
| Assessment of Quality of life (AQoL-6D) | It is a 20-item questionnaire that measures the following dimensions of the patient's health status: illness, independence to live, social relationships, physical and psychological well-being. | Baseline (week 0), 3, 6 and 12 months | 
| Trimbos/iMTA Questionnaire on costs on Psychiatric Illnesses (TIC-P) | Questionnaire used to collect information on health services and medication received during the last months, as well as, information on productivity loss in paid and unpaid work depending on the illness. | Baseline (week 0), 3, 6 and 12 months. | 
| Client Satisfaction Questionnaire (CSQ-8) | This is a 8-item questionnaire that measures the perception of the attention received. Spanish version by Echeburúa & Corral, 1998 | 3 months | 
| Attitudes Towards Psychological Interventions (APOI) | The questionnaire measures expectations towards online psychological interventions. Its 16 items measure: a) skepticism and risk perception, b) confidence in effectiveness, c) risks of technology and d) anonymous benefits. | Baseline (week 0) | 
| Credibility and Expectancy Questionnaire (CEQ) | This scale is a self-administered 6-item assessment instrument created to measure the belief that the treatment works and the expectations that the treatment will improve. | Baseline (week 0) | 
| Semi-structured qualitative interview | An Ad-hoc instrument with open questions created to investigate the reasons for abandoning treatment. | post-treatment (8 weeks) | 
| Working Alliance Inventory for Online Intervention-Short Form (WAI-TECH- SF) | It is a 12-item self-report adapted of the WAI-SF (Hatcher and Gillaspy, 2006). This questionnaire aimed at assessing the working alliance with the online intervention. | Baseline (week 0) | 
| System Usability Scale (SUS) | The SUS is a 10-item self-report scale from 0 (strongly disagree) to 4 (strongly agree) that measures the usability of a service or product and the acceptance of technology by people who use it. | 3 months | 
| Semi-structured qualitative interview | A 11-item qualitative interview will be developed. It consists of 6 items rated on a scale from 1 (very little) to 5 (very much) and 4 dichotomous questions (yes or no) to assess participants' opinions about the program and the support received. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cultural adaptation, Internet-based intervention, Depression