Depression
Conditions
Keywords
Cultural adaptation, Internet-based intervention, Depression
Brief summary
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
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.
Interventions
BEHAVIORALSmiling is fun
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.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depression symptoms. Beck Depression Inventory- II (BDI-II) | Baseline (week 0), 3, 6 and 12 months. | 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. |
| Change in depression symptoms. Patient Health Questionnaire (PHQ-9) | Baseline (week 0), 3, 6 and 12 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Anxiety Severity and Impairment Scale (OASIS) | post-module (weekly for 8 weeks) | 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 |
| Overall Depression Severity and Impairment Scale ODSIS | post-module (weekly for 8 weeks) | 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). |
| Assessment of Quality of life (AQoL-6D) | Baseline (week 0), 3, 6 and 12 months | 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. |
| Trimbos/iMTA Questionnaire on costs on Psychiatric Illnesses (TIC-P) | Baseline (week 0), 3, 6 and 12 months. | 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. |
| Client Satisfaction Questionnaire (CSQ-8) | 3 months | This is a 8-item questionnaire that measures the perception of the attention received. Spanish version by Echeburúa & Corral, 1998 |
| Generalized Anxiety Disorder Scale (GAD-7) | Baseline (week 0), 3, 6 and 12 months. | 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. |
| Credibility and Expectancy Questionnaire (CEQ) | Baseline (week 0) | 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. |
| Semi-structured qualitative interview | post-treatment (8 weeks) | An Ad-hoc instrument with open questions created to investigate the reasons for abandoning treatment. |
| Working Alliance Inventory for Online Intervention-Short Form (WAI-TECH- SF) | Baseline (week 0) | 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. |
| System Usability Scale (SUS) | 3 months | 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. |
| Attitudes Towards Psychological Interventions (APOI) | Baseline (week 0) | 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. |
| Positive and Negative Affect Schedule (PANAS) | Baseline (week 0), post-module (weekly for 8 weeks), 3, 6 and 12 months. | This scale consists of 2 subscales, each with 10 items that value positive and negative affects. Spanish version by Lopez-Gomez, Hervas, & Vazquez, 2015. |
Countries
Ecuador
Contacts
Primary ContactCarlos E Quiñonez, MSc
Outcome results
None listed