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临床试验/NCT02369393
NCT02369393已完成不适用

Treatment of Depression: Efficacy and Efficiency of Two Self-administered Online Intervention Protocols Based on Behavioral Activation and Physical Activity

Universitat Jaume I2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Change in the Beck Depression Inventory

研究概览

简要总结

To compare the clinical and cost-effectiveness of Behavioral Activation (BA) and Physical Activity (PA) for adults with major depressive disorder (MDD) or adjustment disorder with depressive symptomatology with a wait list control group (WL) in Spanish population.

详细描述

Research shows that in 2030 (Mathers and Loncar, 2006) depression will become one of the three leading causes of disability. 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, but with similar levels of clinical efficacy and quality of care.

In Spain the trial will be carried out in a community sample, comparing the clinical and cost-effectiveness of BA or PA with WL for adults with major depressive disorder (MDD) and adjustment disorder with depressive symptomatology. Respondents will be followed until 6 months after baseline (measures will be taken at BL, 3 months, and 6 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

入选标准

  • Being 18 years of age or older
  • Meet DSM-IV diagnostic criteria for MDD and adjustment disorder confirmed by MINI International Neuropsychiatric Interview version 5.0 and SCID I
  • 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).

结局指标

主要结局

Change in the Beck Depression Inventory

时间窗: Change from baseline to 2 months, 5 months, and 8 months

Change in Patient Health Questionnaire-9

时间窗: Change from baseline to 2 months, 5 months, and 8 months

次要结局

  • Change in the Ryff Scale of Psychological Wellbeing(Change from baseline to 2 months, 5 months, and 8 months)
  • Change in the Environmental Reward Observation Scale (EROS)(Change from baseline to 2 months, 5 months, and 8 months)
  • Change in the Positive and Negative Affect Scale (PANAS)(Change from baseline to 2 months, 5 months, and 8 months)
  • Change in the EQ-5D-5L (EuroQol)(Change from baseline to 2 months, 5 months, and 8 months)
  • Change in the Quality of Life (QLI)(Change from baseline to 2 months, 5 months, and 8 months)
  • Change in the Overall Anxiety Severity and Impairment Scale (OASIS)(Change from baseline to 2 months, 5 months, and 8 months)
  • Change in the Happiness Scale (Fordyce)(Change from baseline to 2 months, 5 months, and 8 months)
  • Change in the Satisfaction with Life Scale (SWLS, Diener)(Change from baseline to 2 months, 5 months, and 8 months)
  • Change in Beck Depression Inventory (BDI-II)(Change from baseline to 2 months, 5 months, and 8 months)
  • Change in the Behavioral Activation for Depression Scale - Short Form (BADS-SF)(Change from baseline to 2 months, 5 months, and 8 months)

研究者

发起方
Universitat Jaume I
申办方类型
Other
责任方
Sponsor

研究点 (2)

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