Randomized Controlled Trial of Prompt Mental Health Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 774
- 试验地点
- 2
- 主要终点
- Recovery rate
研究概览
简要总结
Anxiety and depression are among the most common mental disorders in the population. Anxiety and depression have significant consequences at the individual, family and community level, and mental illness is estimated to cost the Norwegian society 180 billion Norwegian kroner annually. The majority of this amount is accounted for by anxiety and depression disorders. Meanwhile, access to mental health services to treat these disorders is limited. The proportion of people who do not receive treatment of those who are in need of treatment is estimated to be over 50%.
Prompt Mental Health Care (PMHC) is a pilot project initiated in 2012 by the Directorate of Health commissioned by the Ministry of Health, with the goal of increasing access to evidence-based treatment for adults with anxiety disorders and mild-to-moderate levels of depression. The treatment offered is cognitive behavioural therapy and should lead to reduced levels of symptoms of anxiety and depression, improved quality of life and better employability. PMHC is based on the English program "Improving Access to Psychological Therapy (IAPT)", which is established in virtually all health communities in England.
The evaluations of IAPT and PMHC have until now been based on relatively weak research designs which make it difficult to know to what extent the initiative really has the desired effect. In this study, PMHC is compared with a control group that receives treatment as usual (often provided by the general practioner) in two PMHC pilot sites (Kristiansand and Sandnes). Participants are randomly assigned to either the PMHC or the control group. The investigators aim to include 1100 clients in the study.
The key objectives of this study are to investigate whether PMHC treatment is more effective as compared to treatment in the control group with regard to symptoms of anxiety and depression, work participation, functional status, and mental well-being. Cost-effectiveness of PMHC is also examined.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PHQ-9/GAD-7 scores above cut off Level
- •Being above 18 years of age and a resident in the pilot sites
- •Basic verbal and oral Norwegian proficiency
排除标准
- •Entitled to secondary care services due to eating disorder, suicide risk, bipolar disorder, severe depression, invaliding anxiety, psychotic symptoms, severe substance abuse, and personality disorder.
- •Two or more previous treatment attempts without effect.
- •Serious physical health problem as prime problem
结局指标
主要结局
Recovery rate
时间窗: Baseline to 6-month follow-up
Proportion of clients that have recovered based on predefined cut-offs for the Patient Health Questionnaire (PHQ\<10) and Generalized Anxiety Disorder scale (GAD\<8).
Changes in mean levels of depression and anxiety
时间窗: Baseline to 6-month follow-up
Changes in mean levels of depression and anxiety as measured by respectively PHQ and GAD
次要结局
- Recovery rate / Changes in mean levels of depression and anxiety at 12-month follow-up(Baseline to 12-month follow-up)
- Recovery rate / Changes in mean levels of depression and anxiety at 24-month and 36-month follow-up, experimental group only.(Baseline to 24/36-month follow-up)
- Functional status(Baseline to 12-month follow-up; for experimental group to 36-month follow-up.)
- Health-related quality of life(Baseline to 12-month follow-up; for experimental group to 36-month follow-up.)
- Work participation(Baseline to 12-month follow-up)
- Mental Well-being(Baseline to 12-month follow-up; for experimental group to 36-month follow-up.)
研究者
Robert Smith
Researcher
Norwegian Institute of Public Health