A Multi-Site Randomized Controlled Trial of a Stepped-Care Intervention for Emergency Department Patients With Panic Attacks and Panic Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Singapore General Hospital
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Change in panic scores at every 3 months from baseline using the Panic Disorder Severity Scale (PDSS; Shear et al., 2001)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in panic scores at every 3 months from baseline using the Panic Disorder Severity Scale (PDSS; Shear et al., 2001)
Time Frame: 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.
Secondary Outcomes
- 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)