Treatment of Multi-organ Bodily Distress Syndrome. A Randomized Controlled Trial of the Effects of Acceptance and Commitment Therapy Given as Group Therapy or Workshop Compared to Standard Treatment (Stress-4)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Global Clinical Improvement Scale
研究概览
简要总结
The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with long lasting health problems with no known medical explanation, defined as multi-organ Bodily distress syndrome (BDS). ACT treatment is given as two different types of treatment, a 9-session group therapy and a 1-day workshop followed by an individual consultation, and both are compared to standard treatment, which is one single advisory consultation. The study includes 180 patients.
详细描述
The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with multi-organ Bodily distress syndrome (BDS). BDS is a unifying diagnosis that encompasses a group of closely related conditions such as somatization disorder, fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome. The project consists of a three-armed randomized controlled trial of ACT treatment given as a supplement to standard treatment as either 9-session group therapy or as a 1-day workshop followed by an individual consultation, compared to standard treatment, which is one single advisory consultation.
Primary outcome is patient-rated improvement measured by Clinical Global Improvement Scale (CGI-I). Secondary outcome is functional level (physical, mental and social) measured by the SF-36 Physical Component Summary (PCS). The study includes 180 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories
- •Moderate or severe impact on daily life
- •Symptoms lasting for at least 2 years
- •Age 20-50 years
- •Born in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish.
排除标准
- •Presence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS
- •Patients with treatment demanding psychiatric disease as dominating problem
- •A lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
- •Abuse of alcohol, narcotics or drugs
- •Pregnancy at time of inclusion
研究组 & 干预措施
Group Therapy
ACT given as conventional group therapy in groups of 7-8 patients 3,5 hours each session, 9 sessions during 3 month
干预措施: Acceptance and Commitment Therapy (Behavioral)
Workshop
ACT given as a one-day workshop with 15 patients with a following individual consultation
干预措施: Acceptance and Commitment Therapy (Behavioral)
Standard treatment
Standard treatment is one single advisory consultation given 2 weeks after randomization
干预措施: Acceptance and Commitment Therapy (Behavioral)
结局指标
主要结局
Global Clinical Improvement Scale
时间窗: 14 month after randomization
Questionnaire, patient-rated improvement of health since the beginning of the study.
次要结局
- SF-36(Before randomization, and at 6, 14 and 20 months after randomization)
- Visual Analogue Scale for pain and worst symptom(Before randomization, and at 6, 14 and 20 month after randomization)
- Symptom Checklist (SCL)(Before randomization, and at 6, 14 and 20 month after randomization)
- WHODAS II(Before randomization, and at 6, 14 and 20 month after randomization)