Servant Dominique, Leterme Anne-Claire, Barasino Olivia, Rougegrez Laure, Duhamel Alain, Vaiva Guillaume
Stress and Anxiety Unit, Department of Psychiatry, University Hospital, Lille, France.
Unité Mixte de Recherche 9193 Sciences Cognitives et Sciences Affectives, Centre National de la Recherche Scientifique, Department of Psychiatry, University Hospital Lille, Lille, France.
JMIR Res Protoc. 2017 Oct 2;6(10):e190. doi: 10.2196/resprot.7976.
Adjustment disorder with anxiety (ADA) is the most frequent and best characterized stress-related psychiatric disorder. The rationale for prescription of benzodiazepine monotherapy is a public health issue. Cognitive behavioral stress management programs have been studied in many countries. Several reports have shown beyond reasonable doubt their efficiency at reducing perceived stress and anxiety symptoms and improving patient quality of life. Considering the number of people who could benefit from such programs but are unable to access them, self-help programs have been offered. First presented as books, these programs became enriched with computer-based and digital supports. Regrettably, programs for stress management based on cognitive behavioral therapy (CBT), both face-to-face and digital support, have been only minimally evaluated in France. To our knowledge, the Seren@ctif program is the first French language self-help program for stress management using digital supports.
The aim of this study is to assess the effectiveness of a 5-week standardized stress management program for reducing anxiety conducted via eLearning (iCBT) or through face-to-face interviews (CBT) with patients suffering from ADA compared with a wait list control group (WLC). These patients seek treatment in a psychiatric unit for anxiety disorders at a university hospital. The primary outcome is change in the State Trait Anxiety Inventory scale trait subscale (STAI-T) between baseline and 2-month visit.
This is a multicenter, prospective, open label, randomized controlled study in 3 parallel groups with balanced randomization (1:1:1): computer-based stress management with minimal contact (not fully automated) (group 1), stress management with face-to-face interviews (group 2), and a WLC group that receives usual health care from a general practitioner (group 3). Programs are based on standard CBT principles and include 5 modules in 5 weekly sessions that include the following topics: stress and stress reaction and assessment; deep respiration and relaxation techniques; cognitive restructuring, mindfulness, and acceptance; behavioral skills as problem solving; and time management, healthy behaviors, and emotion regulation. In the Internet-based group, patients have minimal contact with a medical professional before and after every session. In the first session, a flash memory drive is supplied containing videos, audio files, a self-help book portfolio in the form of an eGuide, and log books providing the exercises to be completed between 2 sessions. The patient is encouraged to practice a 20-minute daily exercise 5 or 6 times per week. In the face-to-face group, patients receive the same program from a therapist with 5 weekly sessions without digital support. Interviews and self-assessments were collected face-to-face with the investigator.
The feasibility of this program is being tested, and results show good accessibility in terms of acceptance, understanding, and treatment credibility. Results are expected in 2018.
To our knowledge, this is the first French study to examine the effectiveness of a computer-based stress management program for patients with ADA. The Seren@ctif program may be useful within the framework of a psychoeducative approach. It could also be advised for people suffering from other diseases related to stress and for people with a clinical level of perceived stress.
Clinicaltrials.gov NCT02621775; https://clinicaltrials.gov/ct2/show/NCT02621775 (Archived by WebCite at http://www.webcitation.org/6tQrkPs1u).
伴焦虑的适应障碍（ADA）是最常见且特征最明确的应激相关精神障碍。苯二氮䓬类单药治疗的处方依据是一个公共卫生问题。认知行为应激管理项目已在许多国家得到研究。数份报告已确凿表明其在减轻感知到的应激和焦虑症状以及改善患者生活质量方面的有效性。考虑到有许多人可能从这类项目中获益但无法获得，于是提供了自助项目。这些项目最初以书籍形式呈现，后来增加了基于计算机和数字的支持。遗憾的是，在法国，基于认知行为疗法（CBT）的应激管理项目，无论是面对面形式还是数字支持形式，都仅得到了极少的评估。据我们所知，Seren@ctif项目是首个使用数字支持的法语应激管理自助项目。
本研究的目的是评估一个为期5周的标准化应激管理项目的有效性，该项目通过电子学习（iCBT）或与ADA患者进行面对面访谈（CBT）来减轻焦虑，并与等待名单对照组（WLC）进行比较。这些患者在大学医院的精神科寻求焦虑症治疗。主要结局是在基线和2个月随访之间状态 - 特质焦虑量表特质子量表（STAI - T）的变化。
这是一项多中心、前瞻性、开放标签、随机对照研究，分为3个平行组，随机化均衡（1:1:1）：基于计算机的应激管理且接触最少（非完全自动化）（第1组）、面对面访谈的应激管理（第2组）以及从全科医生处接受常规医疗护理的WLC组（第3组）。项目基于标准CBT原则，在5个每周的课程中包括5个模块，主题如下：应激与应激反应及评估；深呼吸与放松技巧；认知重构、正念与接纳；作为问题解决的行为技巧；以及时间管理、健康行为与情绪调节。在基于互联网的组中，患者在每个课程前后与医疗专业人员接触最少。在第一节课时，提供一个闪存驱动器，其中包含视频、音频文件、以电子指南形式呈现的自助书籍组合以及记录册，记录册提供两节课之间要完成的练习。鼓励患者每周进行5或6次每天20分钟的练习。在面对面组中，患者从治疗师处接受相同的项目，共5个每周的课程且无数字支持。访谈和自我评估与研究者面对面收集。
该项目的可行性正在测试中，结果显示在接受度、理解度和治疗可信度方面具有良好的可及性。预计2018年得出结果。
据我们所知，这是法国第一项研究基于计算机的应激管理项目对ADA患者有效性的研究。Seren@ctif项目在心理教育方法框架内可能有用。对于患有其他与应激相关疾病的人以及感知应激处于临床水平的人也可推荐使用。
Clinicaltrials.gov NCT02621775；https://clinicaltrials.gov/ct2/show/NCT02621775（由WebCite存档于http://www.webcitation.org/6tQrkPs1u）
