Somatic Symptom and Related Disorders: A Pilot Treatment Group and Mixed-Methods Investigation
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Change from baseline self-reported distress related to somatic symptoms at 6 weeks
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a new cognitive behavioural therapy (CBT) group for individuals with a somatic symptom disorder (i.e., Somatic Symptom and Related Disorders from the DSM-5). Patients with somatic symptom and related disorders are underserved by the medical system. Further, there is currently a paucity of research aimed at evaluating treatments for patients with somatic symptom disorders. The limited existing research literature supports CBT as an efficacious treatment in this population, but a standardized means of modifying CBT for somatic symptom disorders has not been developed, and it is unclear if group CBT is effective. In this study, the investigators will evaluate the effectives of a new six session CBT group designed specifically to address commonly-reported difficulties among individuals with somatic symptom disorders, such as somatic symptoms, psychological distress, and related cognitive interference. This study will allow us to validate a new intervention for somatic symptom disorders, and will help to fill the current void of evidence-supported evaluation and treatment protocols to better serve patients with somatic symptom disorders.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older,
- •formally diagnosed with a somatic symptom or related disorder,
- •registered patients of St. Joseph's Healthcare Hamilton, and
- •subjective psychological complaints and somatic complaints causing distress and/or functional impairment.
排除标准
- •individuals with
- •acute and severe depression/suicidal ideation,
- •severe PTSD symptoms,
- •current psychosis,
- •current substance use disorder, or
- •severe cognitive impairment will be excluded from the study and referred to a more appropriate intervention.
研究组 & 干预措施
Intervention
There is no control group for this study, and all participants receive the intervention. Although a few participants will be asked to give additional information during the intake and after the study concludes for quality improvement purposes. Effects of these additional interview questions will be considered during analysis
干预措施: Cognitive-behavioural therapy group for individuals with somatic symptom disorders (Behavioral)
结局指标
主要结局
Change from baseline self-reported distress related to somatic symptoms at 6 weeks
时间窗: Week 1 (prior to intervention), week 6 (post-intervention)
Will be measured with the Patient Health Questionnaire 15-Item (PHQ-15) Somatic Symptom Severity. Scores are added to form a total score ranging from 0-30 with higher values indicating more severe distress related to somatic symptoms.
次要结局
- Baseline performance validity(Week 1 (prior to intervention))
- Performance validity at 6 weeks(Week 6 (post-intervention))
- Baseline estimated level of intellectual ability(Week 1 (prior to intervention))
- Change from baseline intellectual functioning at 6 weeks(Week 1 (prior to intervention), week 6 (post-intervention))
- Change from baseline verbal fluency at 6 weeks(Week 1 (prior to intervention), week 6 (post-intervention))
- Change from baseline overall neurocognitive performance at 6 weeks(Week 1 (prior to intervention), week 6 (post-intervention))
- Change from baseline visual attention and speed at 6 weeks(Week 1 (prior to intervention), week 6 (post-intervention))
- Change from baseline auditory working memory at 6 weeks(Week 1 (prior to intervention), week 6 (post-intervention))
- Change from baseline motor speed at 6 weeks(Week 1 (prior to intervention), week 6 (post-intervention))
研究者
Emily MacKillop
Principal Investigator
St. Joseph's Healthcare Hamilton