Hegy Julia Katharina, Brog Noemi Anja, Berger Thomas, Znoj Hansjoerg
Department of Health Psychology and Behavioral Medicine, Institute of Psychology, University of Bern, Bern, Switzerland.
Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Bern, Bern, Switzerland.
JMIR Res Protoc. 2020 Dec 17;9(12):e21200. doi: 10.2196/21200.
Accidents and the resulting injuries are among the world's biggest health care issues, often causing long-term effects on psychological and physical health. With regard to psychological consequences, accidents can cause a wide range of burdens including adjustment problems. Although adjustment problems are among the most frequent mental health problems, there are few specific interventions available. The newly developed program SelFIT (German acronym: Selber wieder fit nach einem Unfall; "fit again after an accident") aims to remedy this situation by offering a low-threshold, web-based self-help intervention for psychological distress after an accident.
The overall aim is to evaluate the efficacy and cost-effectiveness of the SelFIT program plus care as usual (CAU) compared to only CAU. Furthermore, the program's user-friendliness, acceptance, and adherence are assessed. We expect that the use of SelFIT will be associated with a greater reduction in psychological distress, greater improvement in mental and physical well-being, and greater cost-effectiveness compared to CAU.
Adults (n=240) experiencing adjustment problems due to an accident they had between 2 weeks and 2 years before entering the study will be randomized into either the intervention or control group. Participants in the intervention group receive direct access to SelFIT. The control group receives access to the program after 12 weeks. There are 6 measurement points for both groups (baseline as well as after 4, 8, 12, 24, and 36 weeks). The main outcome is a reduction in anxiety, depression, and stress symptoms that indicate adjustment problems. Secondary outcomes include well-being, optimism, embitterment, self-esteem, self-efficacy, emotion regulation, pain, costs of health care consumption, and productivity loss, as well as the program's adherence, acceptance, and user-friendliness.
Recruitment began in December 2019 and will continue at least until January 2021, with the option to extend this for another 6 months until July 2021. As of July 2020, 324 people have shown interest in participating, and 48 people have given their informed consent.
To the best of our knowledge, this is the first study examining a web-based self-help program designed to treat adjustment problems resulting from an accident. If effective, the program could complement the still limited offerings for secondary and tertiary prevention of psychological distress after an accident.
ClinicalTrials.gov NCT03785912; https://clinicaltrials.gov/ct2/show/NCT03785912.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21200.
事故及其导致的伤害是全球最大的医疗保健问题之一，常常对心理和身体健康造成长期影响。关于心理后果，事故会带来广泛的负担，包括适应问题。尽管适应问题是最常见的心理健康问题之一，但可用的具体干预措施却很少。新开发的SelFIT项目（德语缩写：Selber wieder fit nach einem Unfall；意为“事故后重新恢复健康”）旨在通过提供一种低门槛的、基于网络的自助干预措施来解决事故后心理困扰的问题。
总体目标是评估SelFIT项目加常规护理（CAU）与仅采用常规护理相比的疗效和成本效益。此外，还对该项目的用户友好性、可接受性和依从性进行评估。我们预计，与常规护理相比，使用SelFIT将能更大程度地减轻心理困扰，更大程度地改善身心健康，并具有更高的成本效益。
在进入研究前2周至2年因事故而出现适应问题的成年人（n = 240）将被随机分为干预组或对照组。干预组的参与者可直接使用SelFIT。对照组在12周后可使用该项目。两组均有6个测量点（基线以及4、8、12、24和36周后）。主要结局是表明适应问题的焦虑、抑郁和压力症状的减轻。次要结局包括幸福感、乐观情绪、痛苦感、自尊、自我效能感、情绪调节、疼痛、医疗保健消费成本和生产力损失，以及该项目的依从性、可接受性和用户友好性。
招募工作于2019年12月开始，至少将持续到2021年1月，还可选择再延长6个月至2021年7月。截至2020年7月，已有324人表示有兴趣参与，48人已签署知情同意书。
据我们所知，这是第一项研究基于网络的自助项目以治疗事故导致的适应问题的研究。如果该项目有效，它可以补充目前事故后心理困扰二级和三级预防方面仍然有限的服务。
ClinicalTrials.gov NCT03785912；https://clinicaltrials.gov/ct2/show/NCT03785912。
国际注册报告识别码（IRRID）：DERR1-10.2196/21200。
