Gallinat Christina, Moessner Markus, Haenssle Holger A, Winkler Julia K, Backenstrass Matthias, Bauer Stephanie
Center for Psychotherapy Research, University Hospital Heidelberg, Bergheimerstr. 54, 69115, Heidelberg, Germany.
Department of Dermatology, University Hospital Heidelberg, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Contemp Clin Trials Commun. 2018 Dec 10;13:100315. doi: 10.1016/j.conctc.2018.100315. eCollection 2019 Mar.
Skin picking disorder is an under-recognized and understudied mental disorder associated with severe psychological and medical consequences. Affected individuals barely receive adequate treatment, given the scarcity of expertise in healthcare professionals and the lack of evidence-based interventions.The present study seeks to evaluate an Internet-based self-help intervention for skin picking ("SaveMySkin") within a pilot study. The intervention is based on cognitive-behavioral therapy (CBT) and provides comprehensive information materials and exercises. A daily supportive monitoring and psychological as well as dermatological counseling via Internet-chat provide additional support. The research questions focus on user attitudes, expectations and reservations, acceptance, adherences and user satisfaction as well as the feasibility of study procedures. Intervention effects will be estimated in order to plan a subsequent efficacy trial.
The pilot study will be conducted within a 2-arm randomized controlled trial design. A sample of = 100 participants will be recruited via Internet. Interested individuals will answer a short screening questionnaire and may register for the study, if they meet the inclusion criteria (age ≥ 17, at least mild severity of skin picking). Following a baseline assessment, the intervention group may use SaveMySkin. The control group will have access to the intervention after completion of a waiting time of three months.
The present trial will provide information on the feasibility and acceptability of an Internet-based intervention for individuals with skin picking. Furthermore, the results will be used to design a randomized controlled trial investigating the efficacy of the intervention.
German Register for Clinical Trials (DRKS): DRKS00015236.
皮肤搔抓障碍是一种未得到充分认识和研究的精神障碍,会导致严重的心理和医学后果。鉴于医疗保健专业人员缺乏专业知识且缺乏循证干预措施,受影响的个体几乎无法获得充分的治疗。本研究旨在通过一项试点研究评估一种基于互联网的皮肤搔抓自助干预措施(“拯救我的皮肤”)。该干预措施基于认知行为疗法(CBT),并提供全面的信息材料和练习。通过互联网聊天进行的每日支持性监测以及心理和皮肤科咨询提供了额外的支持。研究问题集中在用户的态度、期望和保留意见、接受度、依从性和用户满意度以及研究程序的可行性。将估计干预效果,以便计划后续的疗效试验。
试点研究将采用双臂随机对照试验设计进行。将通过互联网招募n = 100名参与者的样本。感兴趣的个体将回答一份简短的筛查问卷,如果符合纳入标准(年龄≥17岁,至少轻度皮肤搔抓严重程度),则可以报名参加研究。在进行基线评估后,干预组可以使用“拯救我的皮肤”。对照组将在等待三个月后才能使用该干预措施。
本试验将提供有关基于互联网的皮肤搔抓干预措施对个体的可行性和可接受性的信息。此外,研究结果将用于设计一项随机对照试验,以研究该干预措施的疗效。
德国临床试验注册中心(DRKS):DRKS00015236。