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
试验速览
- 阶段
- 不适用
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Change in depression symptoms. Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control group
Waiting list control group.
IBI-based automated support
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.
干预措施: Smiling is fun (Behavioral)
IBI-plus human support
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.
干预措施: Smiling is fun (Behavioral)
结局指标
主要结局
Change in depression symptoms. Patient Health Questionnaire (PHQ-9)
时间窗: 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.
Change in depression symptoms. Beck Depression Inventory- II (BDI-II)
时间窗: 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.
次要结局
- Positive and Negative Affect Schedule (PANAS)(Baseline (week 0), post-module (weekly for 8 weeks), 3, 6 and 12 months.)
- Generalized Anxiety Disorder Scale (GAD-7)(Baseline (week 0), 3, 6 and 12 months.)
- Overall Depression Severity and Impairment Scale ODSIS(post-module (weekly for 8 weeks))
- Assessment of Quality of life (AQoL-6D)(Baseline (week 0), 3, 6 and 12 months)
- Semi-structured qualitative interview(3 months)
- Trimbos/iMTA Questionnaire on costs on Psychiatric Illnesses (TIC-P)(Baseline (week 0), 3, 6 and 12 months.)
- Credibility and Expectancy Questionnaire (CEQ)(Baseline (week 0))
- Working Alliance Inventory for Online Intervention-Short Form (WAI-TECH- SF)(Baseline (week 0))
- System Usability Scale (SUS)(3 months)
- Overall Anxiety Severity and Impairment Scale (OASIS)(post-module (weekly for 8 weeks))
- Client Satisfaction Questionnaire (CSQ-8)(3 months)
- Attitudes Towards Psychological Interventions (APOI)(Baseline (week 0))
- Semi-structured qualitative interview(post-treatment (8 weeks))