Efficacy of Seren@ctif, a Computer-Based Stress Management Program for Patients With Adjustment Disorder With Anxiety: Protocol for a Controlled Trial

• Published in: JMIR research protocols 2017-10, Vol.6 (10), p.e190-e190
• Main Authors: Servant, Dominique, Leterme, Anne-Claire, Barasino, Olivia, Rougegrez, Laure, Duhamel, Alain, Vaiva, Guillaume
• Format: Article
• Language: English
• Subjects: Adjustment; Alcohol; Anxiety; Anxiety disorders; Behavior modification; Bioengineering; Chronic fatigue syndrome; Cognitive behavioral therapy; Cognitive science; Cognitive therapy; Computer Science; Human health and pathology; Human-Computer Interaction; Internet; Intervention; Life Sciences; Mental depression; Mental disorders; Mental health; Online instruction; Other; Prevention; Protocol; Psychiatrics and mental health; Psychotherapy; Self help; Stress; Tobacco; Training
• ISSN: 1929-0748; 1929-0748
• 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