Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms
研究概览
简要总结
The main purpose of this study is to conduct a Randomised Controlled Trial (RCT) where we evaluate an internet administrated version of Emotional Awareness and Expression Therapy (I-EAET) in the treatment of Somatic Symptom Disorder (SSD). We will include 160 patients with SSD that will be randomized to taking part of the Internet based treatment for ten weeks (80 patients) or a waiting list control condition (80 patients). A between-subject design will be used. Self-report measures of symptom level and mechanisms of change will be conducted weekly for the primary outcome measures (PHQ-15, BPI-4) and the process measure (EPS-25). The other self-report measures will be conducted before, after treatment and at follow up at 4-month and 12.
详细描述
Research background Somatic Symptom Disorder (SSD; DSM-5) is one of the most prevalent disorders encountered in primary care settings (1). Typically in SSD, distressing somatic complaints are accompanied by abnormal thoughts, feelings, and behaviors, emphasizing the role of psychological factors. The experience of somatic symptoms is commonly associated with high levels of impairment in quality of life, psychological distress or increased healthcare utilization (2). In addition, SSD has been associated with an elevated risk for chronic manifestation and comorbid mental disorders, work loss or early retirement (3). Although cognitive behavior therapy (CBT) is the best evidenced psychological treatment for SSD, effect sizes are rather moderate or even small (4). Therefore the question of how to develop more effective treatment protocols for SSD arises.
Difficulties in emotional processing and expression have been demonstrated with patients with SSD in several studies (5). Importantly though, there are indications that an emotion focus in treatment increases the possibility of symptom reduction for patients with SSD (6). In addition, many patients with SSD have experienced stressful/traumatic life events (7). Hence, another potential reason for the limited effect of CBT for SSD may be that these traumas have not been adequately addressed in treatment.
Emotional Awareness and Expression Therapy (EAET) is an affect-focused psychodynamic form of psychotherapy, that has an explicit focus on emotional processing and resolving attachment trauma (8). There is a promising research support for EAET for treating SSD related disorders, where it has been shown to be more effective than CBT in two randomized controlled trials where fibromyalgia and chronic musculoskeletal pain were targeted, respectively (9,10).
Many of today's models of psychotherapy has been tested as guided self-help via the Internet (11). This is a cost-effective, scalable form of psychotherapy delivery. While there exists promising evidence that Internet-based affect-focused psychodynamic therapy is effective in the treatment of depression and anxiety disorders (12,13), there are no published studies on EAET in the format of guided self-help delivered via the Internet.
Preliminary results from a pilot study on Internet-based EAET However, our own group very recently completed a (yet unpublished) pilot trial of Internet based EAET (I-EAET), with an explicit focus on emotional processing using expressive writing. The project was approved by the Swedish Ethical Review Authority (Dnr 2019-03317). We included 52 patients with SSD who took part of a nine-week program based on EAET. Details of the I-EAET intervention are described in the Methods sections below. A large within-group reduction in somatic symptoms (PHQ-15) was observed (Cohen's d = 1.12; 95% CI: 0.77-1.46). Small to moderate magnitude reductions in anxiety (GAD-7), depression (PHQ-9), trauma related symptoms (PCL-5), and dysfunctional emotional processing (EPS25) occurred. Almost one-quarter of the sample (23.1%) achieved a 50% or greater reduction in somatic symptoms. The treatment also significantly increased patient's ability to take part in social and family life (Sheehan Disability Scale). The results were maintained at a four month follow-up. While the results are to be interpreted carefully, the effects seem promising. Further research studies on I-EAET using randomized controlled trials are warranted.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •A total score ≥5 on the PHQ-15
- •A diagnosis of SSD according to the DSM-5, i.e ≥1 of the 3 of: disproportionate thoughts about the somatic symptom, persistently high level of anxiety, or excessive time and energy devoted in regard to symptoms or health concerns
- •Symptom duration ≥6 months
- •Written statement from a medical professional that states that a medical evaluation has been conducted.
排除标准
- •Alcohol or substance addiction
- •A diagnosis of a psychological condition that might require other treatment (e.g., psychosis, suicidality, etc)
- •Other severe medical condition
- •Ongoing psychological intervention or psychotherapy that target somatic symptoms
- •Ongoing medical treatment that may interfere with the psychological treatment.
结局指标
主要结局
Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms
时间窗: FU at 12 months.
Measuring pain symptoms
Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms
时间窗: FU at 12 months
Measuring somatic symptoms
次要结局
- Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms(FU at 12 month)
- Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability(FU at 12 month)
- Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms(FU at 12 month)
- Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms(FU at 12 month)
- Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms(FU at 12 month)
- Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms(FU at 12 month)
- Negative Effects Questionnaire, min (0), max (128), higher score indicate more severe negative effects(FU at 12 months)
- Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity(FU at 12 months)
- Level of Emotional Awareness Scale, min (0), max (100), higher score indicate better emotional awareness capacity(FU 4 month)
研究者
Robert Johansson
PhD
Karolinska Institutet