Department of General Internal Medicine and Psychosomatics, Heidelberg University, Im Neuenheimer Feld 410, D-69120, Heidelberg, Germany.
Institute of Medical Biometry and Informatics (IMBI), Heidelberg University, Heidelberg, Germany.
Trials. 2021 May 5;22(1):327. doi: 10.1186/s13063-021-05289-3.
Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (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 examine the effectiveness and cost-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 randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation.
To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany.
ClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.
大多数患有精神障碍的人，包括那些患有严重和慢性障碍的人，都仅由他们的全科医生（GP）进行治疗。然而，某些特定患者可能需要专门的精神卫生保健。值得注意的是，精神卫生专家护理的可及性主要受到以下因素的影响：（a）预约专家的等待时间长，（b）前往专家的旅行距离长，特别是在农村和偏远地区，以及（c）患者对精神卫生专家护理的保留意见（包括担心寻求此类护理会受到污名化）。为了减轻这些障碍，已经提出了基于技术的综合护理模式。本研究的目的是检验精神卫生专家视频咨询模式与初级保健中抑郁症或焦虑症患者的常规治疗相比的有效性和成本效益。
在一项个体随机、前瞻性、双臂优效性试验中，将在德国的全科医生实践中招募 N = 320 名患有焦虑和/或抑郁障碍的患者。干预措施包括一种新开发的基于视频咨询的治疗模式，重点是精神卫生专家进行诊断、治疗计划和短期干预。我们将系统地比较这种新模式与全科医生常规治疗的有效性、成本效益和不良反应：主要结局是使用患者健康问卷焦虑和抑郁量表（PHQ-ADS）从基线到基线评估后 6 个月时的平均抑郁和焦虑症状严重程度的绝对变化。两组的随访将由盲法结局评估者在基线后 6 个月和 12 个月进行。主要分析将基于意向治疗原则。我们将通过严格的患者纳入标准、增强的干预完整性和进行过程评估来优化治疗效果的可能性。
据我们所知，这是在德国首次针对基于视频的、针对全科医生患者的焦虑和抑郁障碍综合护理模式进行的确认性研究。
ClinicalTrials.gov，美国国立卫生研究院 NCT04316572. 于 2020 年 3 月 20 日前瞻性注册。
