Studies on the Effectiveness and Equivalence of an Internet-based Virtual Classroom Intervention for Psychosomatic Aftercare According to the Hannover Curriculum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,023
- 试验地点
- 2
- 主要终点
- change of psychic and somatoform complaints
研究概览
简要总结
Outpatient psychosomatic aftercare after inpatient rehabilitation pursues the goal of helping patients to transfer the achieved rehabilitation result in everyday life and professional life. The Hanover Curriculum has been established as a treatment programme for psychosomatic aftercare. This comprises 25 weekly group sessions and two single therapies at the beginning and at the end of the therapy.
In Germany a vast majority of rehabilitants in a psychosomatic rehabilitation clinic has an indication for psychosomatic aftercare, but it is used only by less than half of the patients due to a lack of aftercare therapists. If there is a therapist in the patient's vicinity, there are often long travelling times to the therapist or the patients might feel stigmatized participating in a face-to-face therapy.
Thus, the expansion of internet-based aftercare services is recommended. Advantages are that they can be carried out at home, possible cost and time savings and improvement of the care situation.
Several meta-analyses provide high evidence for the effectiveness of internet-based therapy offers in depressive and anxiety disorders that are frequent among psychosomatic rehabilitation patients. First randomised controlled studies show that internet-based aftercare services can lead to a symptomatic improvement and to a reduction of relapses. It is currently not clear whether established aftercare concepts, such as the Curriculum Hannover, are also effective in an internet-based format (Curriculum Hannover Online).
The present project consists of a superiority study, examining whether participation in Curriculum- Hannover-Online leads to a stronger adoption and maintenance of the health improvements achieved in inpatient rehabilitation in comparison to care as usual, and an equivalnece study, examining, wether the Curriculum Hannover Online is an equivalent treatment option to the existing face-to-face aftercare therapy.
详细描述
The use of information and communication technology with the aim of promoting mental health can be described as "e-Mental Health", which is regularly used synonymously with the term "internet-based interventions".
With regard to the study situation on internet-based aftercare interventions, especially in Germany, the research is in an early phase. An overview of the possible uses of internet-based treatment approaches in rehabilitation can be found in Lin, Ebert, Lehr, Berking and Baumeister (2013) and - based on the contributions of the Rehabilitation Science Colloquium since 2008 - Baumeister, Lin and Ebert (2013). However, the first randomised controlled studies on aftercare show, in agreement with the studies outlined above, that corresponding offers led to a reduction in relapses compared to Care as Usual (CAU) (Bauer, Okon, Meermann, Kordy, 2013; Ebert, Tarnowski, Gollwitzer, Sieland& Berking, 2013).Both interventions represent new conceptual developments. Regarding the positive findings on the effectiveness of internet-based interventions and with a view to the suboptimal care situation, Kobelt, Winkler and Petermann (2011), for example, recommend the expansion of internet-based aftercare services and their evaluation.
The planned project aims to develop an internet-based variant of the aftercare concept Curriculum Hannover (Curriculum-Hannover-Online), to integrate it into routine care and to test its effectiveness. The technology of the virtual classroom is particularly suitable for internet-based interventions providing group therapy (cf. Wolever et al., 2012).
For this purpose, the existing manual for Curriculum Hannover (cf. Kobelt et al., 2002) is adapted in the course of the process for the needs of an online intervention. The therapists will be prepared for the specifics of the medium through a train-the-trainer-training for learning how to specifically establish and maintain a therapeutic relationship between therapist and participants. It is assumed that this new program for outpatient aftercare after inpatient psychosomatic rehabilitation can be an effective and useful therpy for patients who do not have access to the existing face-to-face aftercare therapies.. The Virtual Classroom is a direct, video- or audio-synchronous and multimedia contact between therapist and patient.
The main question of the superiority study is:
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients after psychosomatic rehabilitation
- •indication for outpatient psychosomatic aftercare are included in both studies.
- •access to a standard PC and broadband internet connection is required (DSL or LTE).
排除标准
- •Persons who are
- •are discharged with a capacity of less than three hours per day on the general labour market,
- •receive or have applied for a pension of at least two-thirds of the full pension,
- •receive a benefit that is regularly paid until the start of an old-age pension.
- •suffering from acute addiction disorder / acute psychosis
结局指标
主要结局
change of psychic and somatoform complaints
时间窗: up to 18 months
according to the HEALTH-49 (Rabung et al., 2009)
次要结局
- change of employment prognosis(up to 18 months)
- change of phobic anxiety(up to 18 months)
- change of interactional difficulties(up to 18 months)
- change of self-efficacy(up to 18 months)
- change of somatoform complaints(up to 18 months)
- change of mental well-being(up to 18 months)
- change of social support(up to 18 months)
- change of social stress(up to 18 months)
- change of depressiveness(up to 18 months)
- change of activity and participation(up to 18 months)
- change of workability(up to 18 months)
研究者
Dr. Alina Dahmen
Director
Dr. Becker Hospital Group