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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
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.
Carlos Quiñonez Freire
Santo Domingo, Ecuador
RECRUITINGChange 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.
Time frame: 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.
Time frame: Baseline (week 0), 3, 6 and 12 months.
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.
Time frame: 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.
Time frame: 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
Time frame: post-module (weekly for 8 weeks)
Overall Depression Severity and Impairment Scale ODSIS
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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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline (week 0)
Semi-structured qualitative interview
An Ad-hoc instrument with open questions created to investigate the reasons for abandoning treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months