ImPROving Cross-sectoral Collaboration Between Primary and Psychosocial Care: A Randomised Controlled Superiority Trial to Compare the Effectiveness of a Mental Health Specialist VIDEo Consultations Model Versus Treatment as Usual in Patients With Depression or Anxiety Disorders in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)
研究概览
简要总结
Even in Western health care systems, most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for specialists, (b) long travel distances to specialists, particularly in rural and remote areas, (c) patients' reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to measure the effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. In an individually randomized, prospective, two-arm superiority study with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in GP practices.
详细描述
The purpose of this study is to measure the effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. In total, the investigators plan to enrol 320 patients who will be randomly allocated to the experimental condition (mental health specialist video consultations) or the control condition (treatment as usual from their GP) in a 1:1 ratio. General practitioners will recruit patients during their regular clinic hours. If the patient is interested in participation, the patient will receive the informed consent form and the baseline questionnaire from the GP. The practice team will send the patient's contact details to the study team who will screen the patient with respect to the eligibility criteria.
Patients will be randomly allocated to one of the two study conditions (video consultation model vs. treatment-as-usual, TAU) in a 1:1 ratio by central randomisation.
The evaluation of the primary outcome will be performed according to the intention-to-treat principle.
The health economic evaluation will be carried out from the perspective of society. A cost-effectiveness and a cost-utility analysis will be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (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
- •at least one of the following psychological conditions i) at least moderately severe depression, defined as a PHQ-9 score of 10 or greater with either item one and/or two being endorsed, ii) at least moderately general anxiety disorder, defined as a Generalized Anxiety Disorder (GAD)-7 score of 10 or greater, or iii) exceeding the cut off of 11 points of the combined anxiety and depression score (PHQ-ADS)
- •currently no or as yet insufficient treatment (psychotherapy, psychopharmacotherapy, or both) or difficulty with adherence
- •capable of giving consent
- •written informed consent
排除标准
- •substance abuse/dependence that is likely to compromise intervention adherence
- •risk of endangerment to others and/or risk of self-endangerment
- •need for emergency medical treatment
- •acute psychotic symptoms
- •severe cognitive impairment or dementia
- •significant hearing and/or visual impairment
- •pregnancy in the ≥ 2nd Trimester
- •prior experience with video consultations as part of the feasibility trial
- •insufficient German language proficiency
结局指标
主要结局
The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)
时间窗: 6 months after inclusion
composite measure of depression and anxiety (range: 0-48 Points, higher score indicates more severly depressed/anxious)
次要结局
- The Patient Health Questionnaire (PHQ-9)(6 months after inclusion, 12 months after inclusion)
- Generalized Anxiety Disorder Scale (GAD-7)(6 months after inclusion, 12 months after inclusion)
- Patient Assessment of Chronic Illness Care (PACIC)(6 months after inclusion, 12 months after inclusion)
- Questionnaire for the Assessment of Medical and non Medical Resource Utilisation in Mental Disorders (FIMPsy)(6 months after inclusion, 12 months after inclusion)
- The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)(12 months after inclusion)
- Recovery Assessment Scale (RAS-G)(6 months after inclusion, 12 months after inclusion)
- Short-Form Health Survey 12 (SF-12)(6 months after inclusion, 12 months after inclusion)
- Somatic Symptom Disorder-B Criteria Scale (SSD-12)(6 months after inclusion, 12 months after inclusion)
- EQ-5D(6 months after inclusion, 12 months after inclusion)
研究者
Markus Haun
Internal Medicine Specialist and Head of the Junior Research Group PROVIDE
Heidelberg University