European Comparative Effectiveness Research on Internet-based Depression Treatment - Spanish Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Change in Patient Health Questionnaire-9
研究概览
简要总结
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) in Spanish population.
详细描述
Depression is a common mental disorder with a negative impact on mental well-being, quality of life, and social and work-related functioning both in the short and longer term. Additionally, depression is associated with increased morbidity, mortality, health care utilization and health care costs. On a population level, depression is one of the most costly diseases. The economic costs of depression were estimated at €136.3 billion (EU25) in 2010 in the EU and are still rising. European health care systems face the challenge of improving access to cost-effective treatments while simultaneously working to sustain budgetary stability in times of economic austerity.
Internet-based depression treatment appears a very promising alternative to current routine depression treatment strategies. Meta-analyses have demonstrated the clinical effectiveness and potential cost-effectiveness of Internet-based treatment for depression in controlled research setting. Internet-based treatment thus has the potential to keep depression treatment affordable, as it enables mental health care providers to reach out to large populations needing depression treatment at a better cost-effectiveness than those of standard treatment as usual (TAU), but with similar levels of clinical efficacy and quality of care.
The trials will be conducted in 8 European countries. In Spain the trial will be carried out in routine primary, comparing the clinical and cost-effectiveness of CBT and TAU for adults with major depressive disorder (MDD). Respondents will be followed until 12 months after baseline (measures will be taken at BL, 3 months, 6 months and 12 months).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 18 years of age or older
- •Meet DSM-IV diagnostic criteria for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0
- •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 language (Spanish)
- •Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
- •Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment
研究组 & 干预措施
Treatment as usual
干预措施: Treatment as usual (Other)
Blended CBT treatment
干预措施: Blended CBT treatment (Behavioral)
结局指标
主要结局
Change in Patient Health Questionnaire-9
时间窗: Baseline, 3 months, 6 months and 12 months
The PHQ-9 is a nine-item mood module that can be used to screen and to diagnose patients with depressive disorders. The 9 items are each scored on a 0-3 scale with the total score ranging from 0-27 and higher scores indicating more severe depression. The PHQ-9 has shown to have good psychometric properties (Wittkampf, Naeije, Schene, Huyser, \& van Weert, 2007).
次要结局
- Change in the Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002)(Baseline, 3 months, 6 months and 12 months)
- Change in the Working Alliance Inventory (WAI-SF)(3 months)
- Change in the credibility and expectancy questionnaire (CEQ; Devilly and Borkovec, 2000)(Baseline)
- Change in the EQ-5D-5L (EuroQol)(Baseline, 3 months, 6 months and 12 months)
- Change in the system usability scale (SUS; Brooke, 1996)(3 months)
- Change in the MINI International Neuropsychiatric Interview (M.I.N.I) version 5.0(Baseline and 12 months)
- Change in the Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983)(3 months)
- Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR) US Translation(Baseline, 3 months, 6 months and 12 months)