Multiprofessional Rehabilitation for Exhaustion Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Change from baseline in exhaustion symptoms
研究概览
简要总结
Stress-related mental disorders are today the leading cause of long-term sick leave in Sweden, and a large part of this increase is due to Clinical burnout, in Sweden called "Exhaustion disorder" (ED). Even though clinical guidelines recommend multi-professional rehabilitation (MPR) for ED, few studies have evaluated the effects of these treatment programs in clinical practice. This large-scale open clinical trial investigates whether MPR for ED seems to alleviate symptoms of ED and if it results in return-to-work.
详细描述
This study is carried out at two specialized stress rehabilitation centers in Stockholm. All patients included in the clinics stress rehabilitation program are asked to participate in the study and are recruited consecutively from October 2017 throughout December 2018. An estimate of 400 patients will be included. The treatment program is a 24-week Multiprofessional standardized CBT-rehabilitation consisting of a nine-session CBT group treatment (stress management) followed by a seven-session group treatment in applied relaxation. Parallel to the group treatments patients receives nine sessions of individual CBT, three visits to an MD (for medication, follow-up, and sick-listing), two individual sessions to a physiotherapist and a three session-exercise group. Also, vocational measures are taken through rehabilitation meetings together with the patient's employer (if an employer exists). Primary treatment outcomes will be return-to-work (RTW) and symptoms of ED, anxiety, and depression. Secondary treatment outcomes will be quality of life, pathological worry, psychological flexibility, clinical perfectionism, insomnia, burnout, and symptoms. Predictors of symptom development and RTW will be explored. Also, comorbidity of chronic pain, negative effects of psychotherapy and treatment credibility will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed exhaustion disorder according to criteria established by the Swedish National Board of Health and Welfare
- •18 - 64 years of age
- •Considered suitable for multimodal rehabilitation in group
- •Self-rating of > 4,5 på SMBQ
排除标准
- •Abuse of alcohol or drugs
- •Moderate-high suicidal risk
- •Severe psychiatric illness (severe depression, bipolar, schizophrenia etc.)
- •Untreated PTSD
结局指标
主要结局
Change from baseline in exhaustion symptoms
时间窗: Week 12 and 24
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
Change from baseline in depression
时间窗: Week 12 and 24
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Change from baseline to follow-up in depression
时间窗: Week 12, 24 and 76
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Change from baseline in employment rate
时间窗: Week 24
Sick-leave data collected from the Swedish Social Insurance Agency
Change from baseline to follow-up in employment rate
时间窗: Week 24 and 76
Sick-leave data collected from the Swedish Social Insurance Agency
Change from baseline in anxiety
时间窗: Week 12 and 24
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Change from baseline to follow-up in anxiety
时间窗: Week 12, 24 and 76
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Change from baseline to follow-up in exhaustion symptoms
时间窗: Week 12, 24 and 76
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
次要结局
- Change from baseline to follow-up in pathological worry(Week 12, 24 and 76)
- Change from baseline to follow up in perceived work ability(Week 12, 24 and 76)
- Change from baseline to follow-up in Quality of life(Week 24 and 76)
- Change from baseline in burnout(Week 12 and 24)
- Change from baseline in Psychological Flexibility(Week 12 and 24)
- Change from baseline to follow-up in burnout(Week 12, 24 and 76)
- Change from baseline in insomnia symptoms(Week 12 and 24)
- Change from baseline to follow-up in insomnia symptoms(Week 12, 24 and 76)
- Change from baseline in Clinical Perfectionism(Week 12 and 24)
- Change from baseline in pathological worry(Week 12 and 24)
- Change from baseline in Quality of life(Week 24)
- Change from baseline to follow-up in Psychological Flexibility(Week 12, 24 and 76)
- Change from baseline in perceived work ability(Week 12 and 24)
- Change from baseline to follow-up in Clinical Perfectionism(Week 12, 24 and 76)