A Multi-Site Randomized Controlled Trial of a Stepped-Care Intervention for Emergency Department Patients With Panic Attacks and Panic Disorder
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Panic Attacks and Disorders
- 发起方
- Singapore General Hospital
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Change in panic scores at every 3 months from baseline using the Panic Disorder Severity Scale (PDSS; Shear et al., 2001)
- 状态
- 进行中（未招募）
- 最后更新
- 2年前
概览
简要总结
Using a randomized controlled trial (RCT) design, the main objective of this study is to evaluate the clinical, patient-centered, and economic effectiveness of a stepped-care intervention for patients with panic attacks and panic disorder presenting to the busiest Accident and Emergency (A&E) departments of the largest public healthcare group in Singapore.
The RCT will have two arms: 1) treatment via an enhanced care pathway consisting of a stepped-care intervention for panic attacks and panic disorder; and 2) a control arm consisting of screening for panic attacks and panic disorder in the A&E and discharge (routine care). In addition to the baseline assessment, the study follow-up visits will occur at 1, 3, 6, and 12 months.
详细描述
Specific Aims and Hypotheses Aim 1 (Primary): To evaluate the clinical effectiveness of a stepped-care intervention for A\&E patients with panic attacks and panic disorder as compared to screening alone. Aim 2: To evaluate the patient-centered effectiveness of a stepped-care intervention for A\&E patients with panic attacks and panic disorder as compared to screening alone. Aim 3: To evaluate the incremental cost-effectiveness of a stepped-care intervention for A\&E patients with panic attacks and panic disorder compared to screening alone from the health system perspective.
研究者
入排标准
入选标准
- •Male or female
- •21+ years of age
- •Triage level 2 or 3
- •English or Mandarin speaking
- •Able to provide informed consent and read study materials
- •Presenting complaint of chest pain, palpitations, dizziness, or difficulty breathing
- •Score ≥ 3 on CDR screener
- •Diagnosis of panic attack or panic disorder confirmed on SCID interview
- •Willing to enter randomized trial
排除标准
- •Altered mental status (dementia, psychosis, substance intoxication/withdrawal)
- •Triage level 1
- •Non-English or Mandarin speaking
- •Unwilling or unable to complete study procedures
- •Symptoms of clear cardiac origin as determined by A\&E physician
- •Deemed unfit due to possible adverse respiratory or cardiac outcomes by A\&E physician
- •Clear organic cause for panic symptoms as evidenced by laboratory tests (FBC, UE, ECG, TROPONIN T, CXR)
- •Does not meet criteria for panic attack or panic disorder on SCID interview
- •Received CBT for panic symptoms in previous 12 months
结局指标
主要结局
Change in panic scores at every 3 months from baseline using the Panic Disorder Severity Scale (PDSS; Shear et al., 2001)
时间窗: Baseline, 1st month, 3rd month, 6th month, 12th month
The PDSS is a 7-item semi-structured interview of panic symptom severity. Each item is rated on a 0 (none/mild) to 4 (extreme/severe) scale. A higher total score would represent severe panic symptoms.
次要结局
- Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)(Baseline, 1st month, 3rd month, 6th month, 12th month)
- EQ-5D (EuroQol Group, 1990)(Baseline, 1st month, 3rd month, 6th month, 12th month)
- WHO Disability Assessment Schedule (WHO-DAS; World Health Organization, 2010)(Baseline, 1st month, 3rd month, 6th month, 12th month)
- Psychiatric Diagnostic Screening Questionnaire (PDSQ; Zimmerman & Mattia, 2001)(Baseline, 1st month, 3rd month, 6th month, 12th month)