Halifax Somatic Symptom Disorder Trial: A Randomized Parallel Group Cross-Over Study of Intensive Short-Term Dynamic Psychotherapy Compared to Medical Treatment as Usual for Somatic Symptoms in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in Somatic Symptom Severity score using the SOMS-7 from baseline to week 8
研究概览
简要总结
The purpose of this pilot study is to compare the effectiveness of Intensive Short-Term Dynamic Psychotherapy (ISTDP) plus Medical Care As Usual (MCAU) compared to MCAU for Somatic Symptom and Related Disorders (SSRD). Consenting patients presenting to the emergency department with suspected SSRD will be randomly allocated to receive either 8 weekly individual sessions of ISTDP or to an 8-week wait list followed by ISTDP. MCAU including emergency department and/or family doctor consultation is available throughout trial participation. The primary outcome measure is participant self-reported somatic symptoms at week 8.
详细描述
The purpose of our study Given the significant illness burden associated to somatic symptom and related disorders, and given the marked reduction in ED visits and severity of symptoms following this form of short-term treatment, there is an urgent need to directly examine those patients who do not attend initial consultation or fail to complete treatment. This population is complex and is considered at high risk. Currently, insufficient information is known about the specific baseline characteristics, and the short- and long-term outcomes for these two sub-samples of patients not initiating or not completing treatment.
Objectives
- First, we will examine the outcomes of patients receiving Medical Care As Usual (MCAU) followed by an 8-week wait-list for ISTDP versus MCAU plus ISTDP without wait in order to establish the efficacy of this treatment for somatic symptom disorders.
- Second, we will identify specific patient variables that predict outcomes in order to identify the characteristics of patients with less optimal outcomes and treatment failures.
- Third, we will conduct a preliminary examination of processes underlying symptom change in ISTDP.
Specific goal Through this project, therefore, we will generate new knowledge directly translatable to the goal of improving outcomes for a greater percentage of referred patients. This population is complex and is considered at high risk. There is a pressing need to reach out to a greater number of patients with SSRD, in order to alleviate suffering and reduce the costs associated to repeated health care use.
METHOD
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years
- •Emergency department physician determines that physical symptoms and/ or impairment associated with the physical symptoms are not explained by physical pathology.
- •Patients must meet diagnostic criteria for a Somatic Symptom or Related Disorder (SSRD) as assessed by the Structured Clinical Interview for DSM Disorders 5th Edition Research Version (SCID-5-RV).
- •Symptom duration of at least 3 months or recurrently each month.
- •Cut off of at least 4 symptoms for men and 6 for women using the SOMS.
- •Participants consent to audio-visual taped sessions and the investigator accessing their electronic health records, if deemed necessary.
- •Stable with pharmacotherapy over previous 4 weeks.
排除标准
- •Symptoms which can be entirely explained by a medical condition.
- •Already receiving ongoing psychological treatment.
- •The research physician determines that the physical symptoms and/ or impairment has definite physical pathology.
- •Any diagnosis of current psychosis, bipolar or manic depression, substance abuse/dependence or active suicidality as assessed by the SCID-5-RV.
- •Complaints which are considered to be malingering or factitious.
- •Patients who are unable to give informed consent to treatment.
结局指标
主要结局
Change in Somatic Symptom Severity score using the SOMS-7 from baseline to week 8
时间窗: Baseline, week 8
Symptom score at week 8 in the MCAU group will be compared to the ISTDP group at week 8. Sub-analyses will examine the MCAU score at week 8 versus the ISTDP score at the last session in cases where treatment is extended beyond week 8 treatment to a maximum of 20 sessions.
次要结局
- Change in depression score using the Patient Health Questionnaire-depression scale (PHQ-9) from baseline to 8 weeks(Baseline, week 8)
- Change on Whiteley Index for Health Anxiety from baseline to week 8(Baseline, week 8)
- Change on Inventory of Interpersonal Problems (IIP-32) from baseline to week 8(Baseline, week 8)
- Presence of somatic symptom and related disorder diagnosis using the Structured Clinical Interview for DSM Disorders Version 5- Research Version at week 8(week 8)
研究者
Joel Town
Clinical Psychologist & Assistant Professor
Nova Scotia Health Authority