Acceptance and Commitment Group Therapy for Adolescents With a Range of Functional Somatic Syndromes: Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Change in SF36 (Assessment of physical health)
研究概览
简要总结
Background:
An increasing number of adolescents report recurrent functional somatic symptoms. Some experience persistent symptoms and may receive functional somatic syndromes (FSS) diagnoses (i.e. symptoms not attributable to any known conventionally defined physical disease), characterised by severe disability and reduced quality of life.
The aim of this study is to:
- Develop an Acceptance and Commitment Therapy (ACT)-based group intervention for adolescents with severe FSS (conceptualized as Bodily Distress Syndrome (BDS), see detailed description).
- Examine the efficacy of group based ACT in adolescents (aged 15-19 years) with severe FSS.
The ACT-based treatment, with 9 sessions of group therapy and one follow up meeting is compared to standard treatment/enhanced usual care, which is one single advisory consultation.
The study includes approximately 120 patients.
详细描述
Background:
An increasing number of adolescents report daily physical symptoms, with a current prevalence of 25%. A substantial proportion of these young people is examined in the health care system, most often with the conclusion that their symptoms cannot be explained in terms of a well-defined medical disease and are hence "stress-related" or "functional". Typically, the symptoms remit spontaneously after the patient is reassured. However, approximately 5-10% experience persistent symptoms and reduced functioning. They may receive diagnoses for functional somatic syndromes (FSS) such as chronic fatigue syndrome (CFS), fibromyalgia (FM), recurrent abdominal pain/irritable bowel syndrome (IBS) or idiopathic pain syndrome. These adolescents are at risk of social isolation, long term school-absence and reduced quality of life.
The aetiology of FSS is assumed complex, with interacting biological, psychological and environmental factors. Recent studies suggest that dysfunction of the stress-axes (e.g. the hypothalamic-pituitary-adrenal (HPA) axis and the autonomic nervous system) and activated inflammatory response are likely to play a role in the development and perpetuation of the symptoms in various FSS. Besides common pathophysiological mechanisms, FSS also show similarities in patient characteristics and treatment response, which speaks in favour of a common family of disorders. Recently, the unifying diagnostic category Bodily Distress Syndrome (BDS) was introduced. BDS is conceptualized as a (patho)physiologic response to prolonged or severe mental and/or physical stress in genetically susceptible individuals, and the diagnosis has been shown to encompass the majority of FSS.
FSS in adults can be managed effectively be means of psychological treatment, but the evidence for adolescents with severe FSS is sparse. Family based cognitive behavioural therapy (CBT) and internet-delivered CBT has proven effective for young patients with particular symptom profiles. However, the development of various specific treatments for each FSS or symptom profile is not an efficient strategy. Recent studies suggest that adult patients with various FSS sampled by the BDS diagnosis can feasibly be treated together, regardless of their main somatic complaint. The same may be true for adolescents, and hence the development of a common treatment for adolescents with various FSS or BDS may be advantageous, and facilitate further implementation in routine clinical care if the treatment is found effective.
Acceptance and Commitment Therapy (ACT), which derives from CBT, has shown promising results in children with chronic functional pain. Improvement could be demonstrated by less avoidance of important activities, better emotional wellbeing and less health care utilization. The aim of this project is to develop an ACT-based group intervention for adolescents with a range of FSS, i.e. conceptualised as severe BDS, and to evaluate its efficacy in a randomized controlled trial.
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
- 15 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe Bodily Distress Syndrome (multi-organ type) of at least 12 months duration.
- •15-19 year-old.
- •Born in Denmark or by Danish parents. Understand, speak and read Danish.
排除标准
- •No informed consent.
- •An acute psychiatric disorder demanding other treatment, or if the patient is suicidal.
- •A lifetime diagnosis of psychosis, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.2, F33.3), serious cognitive deficits or developmental disorders such as mental retardation and autism (ICD-10: F70, F84).
- •Abuse of narcotics, alcohol or medicine.
- •Pregnancy at the time of inclusion.
- •Not fit for group based treatment, e.g. patients with severe ADHD (ICD-10: F90), severe social phobia (ICD-10: F40.1) or conduct disorder (ICD-10: F91).
结局指标
主要结局
Change in SF36 (Assessment of physical health)
时间窗: At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.
Questionnaire, patient rated. Physical health measured with aggregate scores of the scales PF (physical functioning), BP (bodily pain) and VT (vitality).
次要结局
- Change in SF36 Questionnaire (Assessment of health related quality of life)(At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.)
- Change in BDS checklist (Assessment of symptom severity)(At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).)
- Change in SCL-somatization Questionnaire (Assessment of functional symptoms)(At baseline (i.e. at clinical assessment) and 2, 4, 5½, 8 and 12 (primary endpoint) months after baseline.)
- Change in Limitation index Questionnaire (Assessment of symptom interference)(At baseline (i.e. at clinical assessment) and 5½, 8 and 12 months after baseline (primary endpoint).)
- PGIC (Patient Global Impression of Change)(At 5½, 8 and 12 (primary endpoint) months after baseline.)
- Change in SCL-8, SCL-6, SCL-4 Questionnaire (Assessment of depression and anxiety)(At baseline (i.e. at clinical assessment) and 5½, 8 and 12 (primary endpoint) months after baseline .)
- Change in level of inflammatory and oxidative stress(At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).)
- Level of physical activity (Anthropometric measurements with accelerometer (Actigraph GT3X)(At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).)
- Change in HRV heart rate variability (assessment of stress response in various situations (resting state, standing, slow breathing and valsalva)(At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).)
- Change in hair cortisol (Measurement of the level of stress-hormone cortisol in hair)(At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).)
- Change in PSS (Perceived Stress Scale)(At baseline (i.e. at clinical assessment) and 12 months after baseline (primary endpoint).)