A Randomized Controlled Trial of a Web and Mobile Guided Psychological Intervention for Depressive Symptoms in Turkey.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 444
- 试验地点
- 2
- 主要终点
- Change on Beck Depression Inventory-II
研究概览
简要总结
The aim of this study is to test the clinical effects of a web and mobile application of guided Problem Solving Therapy for depressive symptoms among the general population in Turkey.
详细描述
In Turkey, there are serious deficiencies in mental health care. Among these, undertreatment of mentally ill patients, lack of psychologists and inadequate psychosocial and rehabilitation options for patients and their relatives are important prohibiting factors that reduce patients' outreach for getting help. While depression is highly prevalent (4.4%), only a small number of people seek professional help (18%) in Turkey. Innovative solutions are needed to overcome this treatment gap. Online Problem-Solving Therapy (PST) is a brief intervention proven to be effective in the treatment of depression, although little is known about its clinical effects in Turkey.
The aim of this study is to test the clinical effects of a web and mobile application of PST for depressive symptoms among the general population in Turkey.
Participants will be recruited through announcements in social media and the Middle East Technical University. A randomized controlled trial with a sample size of 444 participants randomized across three groups will be utilized. The first experimental group will receive direct access to the web version of the intervention; the second experimental group will receive direct access to the mobile app of the intervention as well as automated supportive text messages based on PST. The control group consists of a wait-list and for ethical reasons, participants in this group will gain access to the intervention (either web or mobile application) four months after the baseline. The intervention is based on an existing PST for the Turkish population, "Her Sey Kontrol Altinda" (HSKA).
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Turkish participants living in Turkey are eligible if the applicants are aged between 18-55 years and have mild to moderate depressive symptoms (Beck Depression Inventory-II score between 10 and 29).
排除标准
- •Participants will be excluded if they have a BDI-II score above 29, or a medium-to- high suicidal risk (according to the MINI-International Neuropsychiatric Interview) and are advised to contact a psychiatrist or clinical psychologist.
研究组 & 干预措施
HSKA - Web Group
The first experimental group will receive direct access to the web version of HSKA.
干预措施: Her Sey Kontrol Altinda (HSKA) (Behavioral)
HSKA - Mobile Group
The second experimental group will receive direct access to the mobile app of HSKA as well as automated supportive text messages based on PST.
干预措施: Her Sey Kontrol Altinda (HSKA) (Behavioral)
Control Group
The control group consists of a wait-list and for ethical reasons, participants in this group will gain access to the intervention (either web or mobile application) four months after the baseline.
结局指标
主要结局
Change on Beck Depression Inventory-II
时间窗: Screening; baseline, 6-8 weeks after baseline and 4 months after baseline
Depressive symptoms
次要结局
- Change on Penn State Worry Questionnaire (PSWQ)(baseline, 6-8 weeks after baseline and 4 months after baseline)
- Satisfaction with the intervention questionnaire(6-8 weeks after baseline only in the two experimental groups)
- Change on State-Trait Anxiety Inventory (STAI)(baseline, 6-8 weeks after baseline and 4 months after baseline)
- Change on Perceived Stress Scale (PSS)(baseline, 6-8 weeks after baseline and 4 months after baseline)
- Change on General Self-Efficacy Scale (GSE)(baseline, 6-8 weeks after baseline and 4 months after baseline)
- Change on EuroQol-5D-5L (EQ-5D-5L)(baseline, 6-8 weeks after baseline and 4 months after baseline)
研究者
Burçin Ünlü İnce
Ph.D., Postdoctoral Researcher
The Scientific and Technological Research Council of Turkey