European Comparative Effectiveness Research on Internet-based Depression Treatment in Poland [Europejskie Badania Porównawcze Nad Efektywnością Interwencji Internetowej Dla Osób z Depresją] (E-COMPARED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change from Baseline Depression at 12 months
研究概览
简要总结
Effective, accessible, and affordable depression treatment is of high importance considering the large individual and economic burden of depression. There is ample support for the effectiveness of Internet-based Cognitive Behavioral Therapy (CBT) for depression which is considered a promising alternative to routine depression treatment strategies. Most evidence comes from randomized controlled trials, however, and not from research in routine practice.
The European Comparative Effectiveness Research on Internet-based Depression Treatment (E-COMPARED) in Poland aims to compare the clinical and cost-effectiveness of blended CBT for adults with major depressive disorder (MDD) with treatment as usual (TAU). The trial will be conducted in routine mental health care in Poland, and is a part of the bigger project funded by European Commission (Grant Agreement No: 603098). In this randomized controlled trial, a total of 150 patients with MDD will be assigned to one of two conditions: 1) blended CBT, 2) TAU. Respondents in both conditions will be followed until 12 months after baseline (measures will be taken at baseline, 3 months, 6 months and 12 months).
详细描述
Introduction
Good mental health is of high value from an individual, economic and social perspective. Depression is a serious threat to such a good mental health and highly prevalent worldwide. On a yearly basis about 7% of the European population (around 30 million people) suffer from a major depression (MDD) (Wittchen et al., 2011). If we take subclinical forms of depression into account the prevalence rises up to 15%.
Depression is not only highly prevalent; it is marked by disabling emotional and physical symptoms. It has a severe negative impact on mental wellbeing, quality of life and social and work-related functioning of those who suffer from it both on the short and longer term. This impact equals at least conditions such as diabetes mellitus, heart disease and arthritis (Sprangers et al., 2000). Depression is associated with increased morbidity, mortality, health care utilization and health care costs. The World Health Organisation has predicted that depression will be the foremost overall cause of disability by 2030 (Mathers, & Loncar, 2006).
Objective
The main objective of the planned research is to compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet DSM-IV diagnostic criteria for MDD as confirmed by the telephone administered MINI International Neuropsychiatric Interview version 5.0 and a score a score of 5 or higher on the PHQ-9 screening questionnaire.
排除标准
- •Current high risk for suicide according to the MINI Interview section C
- •Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
- •Currently receiving psychological treatment for depression in primary or specialised mental health care
- •Being unable to comprehend the spoken and written Polish
- •Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
- •Not having a Smart phone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone if one is provided with one by the research team for the study duration.
研究组 & 干预措施
Blended CBT
Internet based blended depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components. The core components of the CBT treatment are: (1) psycho-education, (2) cognitive restructuring, (3) behavioural activation, and (4) relapse prevention. These will be delivered over 13 sessions (6 online and 7 face-to-face, session sequence - alternate, online platform - Moodbuster).
干预措施: Blended Cognitive Behavioural Therapy (CBT) (Behavioral)
Treatment as usual
Treatment as usual (TAU) will be defined as the routine care CBT that subjects receive when they are diagnosed with depression in the setting of recruitment. We will not interfere with treatment as usual but we will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report (including TIC-P measurements).
干预措施: Treatment as usual (Behavioral)
结局指标
主要结局
Change from Baseline Depression at 12 months
时间窗: Baseline, 12 months
Symptoms of depression will be assessed with the 9-item self-report The Patient Health Questionnaire (PHQ) (Kroenke et. al., 2001).
次要结局
- Change from Baseline Health Service Uptake and Production Loss Due to Illness at 12 months(Baseline, 12 months)
- Patient's Satisfaction with the Treatment(3 months)
- Satisfaction with the Platform(3 months)
- Change from Baseline Diagnosis of Depression at 12 months(Baseline, 12 months)
- Alliance between the Patient and Technologies(3 months)
- Change from Baseline Symptoms of Depression at 12 months(Baseline, 12 months)
- Patients' Expectancy of Treatment(Baseline)
- Therapeutic Alliance(3 months)
- Change from Quality of Life at 12 months(Baseline, 12 months)
研究者
Roman Cieslak
Vice-Rector for Research
University of Social Sciences and Humanities, Warsaw