Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- Change of saliva cortisol
研究概览
简要总结
This study intents to determine who will benefit from an intensive brief stress coping intervention week (ISCIW) as secondary prevention for real world affective disorder patients.
详细描述
Affective disorders are associated with a substantial personal and socio-economic burden. This study evaluates an intensive brief stress-coping intervention week (ISCIW) as feasible follow-up treatment for real world patients who suffer from this highly prevalent and chronic stress-related disorders. Stress-associated blood (Interleukin-6, Homocystein, Myeloperoxidase), saliva cortisol and psychosocial screening parameters will be analyzed to determine who will benefit from the ISCIW. All patients were identified in a preventive medical screening before pre-treatment for at least three month as outpatient and the following inclusion to the follow-up ISCIW-trial at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria. For the three planed groups and interventions see interventions and arms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Affective or anxiety disorder DSM-IV diagnosis (structured interview, M.I.N.I. International Neuropsychiatric Interview )
- •Minimum 3-weeks previous therapeutic treatment as outpatient at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria
- •Clinical Global Impression - Severity (CGI-S) score > 2 points
- •Minimum improvement of 1 CGI-S points as outpatient
- •Written informed consent
排除标准
- •More than 60 days away sick per year in the last year before intervention
- •Therapy adherence as outpatient at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria
- •Work Ability Index (WAI) score < 25 points
- •Major neurological or cognitive deficits
- •Current psychotic symptoms
- •Current or previous DSM-IV diagnosis of substance dependence, except for nicotine or current substance abuse
- •Failures to comply with the study protocol or to follow the instructions of the study team
- •Currently requested application for retirement
- •Middle to high suicidal tendency in the M.I.N.I.-examination
结局指标
主要结局
Change of saliva cortisol
时间窗: Change from baseline saliva sample at week 1 to end of study visit at week 38
次要结局
- Change of myeloperoxidase(Change from baseline at week 1 to end of study visit at week 38)
- Change of interleukin-6(Change from baseline at week 1 to end of study visit at week 38)
- Change of psychometric stress-index (Questionnaire)(Change from baseline at week 1 to end of study visit at week 38)
- Change of homocystein(Change from baseline at week 1 to end of study visit at week 38)
研究者
Robert Winker
Prim.Priv. Doz. Dr.
Medical University of Vienna