Effectiveness of Two Stress Management Programs in the Adaptation Disorder With Anxiety (ADA) : Computer-based or Face- to -Face to Face Versus Control Group.Open Multicenter Prospective Randomized Controlled Therapeutic 3 Parallel Groups
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Score of State-Trait Anxiety Inventory (STAI-S),
研究概览
简要总结
The aim of this study was to assess the effects of a 5-week standardized cognitive behavioral treatment of stress management conducted via e-learning or face-to-face on patients responding to the diagnosis of adjustment disorder with anxiety (ADA) according to the DSM- 5 (Diagnostic and Statistical Manual of Mental Disorders Fifth Edition) criteria .
详细描述
The program includes 5 weekly sessions that the patient follows. It is based on standard CBT (Cognitive Behavioural Therapy) principles and includes five modules (information about stress and stress reaction and assessment; deep respiration and relaxation techniques; cognitive re-structuration; mindfulness and acceptation; behavioral skills as solving problem, time management, healthy behaviors, problem solving and emotion regulation …).
- In internet-based group patient benefits from a minimal contact with a medical member of staff before and after every session. It is supplied to the patient, from the first session an USB key containing videos, audio files, help-self book portfolio in the form of e-guide, log books with the program of the exercises to be realized between two session of the 5 sessions program. The patient is encouraged to practice a twenty-minutes daily of exercises five or six days per week.
- In face-to-face group, patient receive the same program with a therapist in 5 weekly sessions without digital supports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adjustment disorder with anxiety (ADA) according DSM-5 (The diagnosis was made according to the MINI questionnaire).
- •Subscore anxiety > 10, subscore depression < 10 at Hospital Anxiety Depression Scale (HADS)
- •Computer at home
排除标准
- •Subscore anxiety < 10, subscore depression > 10 at Hospital Anxiety Depression Scale (HADS)
- •No others current psychiatric diagnostic according DSM- 5
- •No suicidal ideation
结局指标
主要结局
Score of State-Trait Anxiety Inventory (STAI-S),
时间窗: Between baseline and 2 month of use
self-administered questionnaire of 20 items side on 4 levels from 'not at all' to one side "many" side 4 (total score of 20-80). It measures an intensity of more anxiety and is not related to an anxiety disorder.
次要结局
- The Penn-State Worry Questionnaire (PSWQ),(at 2 months, at 6 months)
- The Perceived Stress Scale (PSS)(at 2 months, at 6 months)
- Visual Analogue Scale for stress (VAS-stress)(at 2 months, at 6 months)
- Hospital Anxiety and Depression scale (HAD),(at 2 months, at 6 months)
- The Beck depression inventory (BDI-21)(at 2 months, at 6 months)