A Multi-Site RCT of a Stepped-Care Intervention for Emergency Department Patients With Panic Attacks and Panic Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-Site Randomized Controlled Trial of a Stepped-Care Intervention for Emergency Department Patients With Panic Attacks and Panic Disorder

Conditions
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Panic Attacks and Disorders

Intervention / Treatment
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* Behavioral: Stepped Care Intervention (STEP)
* Diagnostic Test: Screening only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 stage parallel group multi-site RCT design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stepped Care Intervention (STEP)<br>In a stepped-care model, all patients start with an evidence-based intervention of low intensity as a first treatment step. Progress is monitored and patients who do not respond adequately can subsequently be 'stepped up' to a higher intensity treatment. This model is now being recommended as the best strategy for treating panic attacks and panic disorder. | Behavioral: Stepped Care Intervention (STEP)<br>* A stepwise progression of intervention according to the participant's response to the increasing levels of therapy. There will be 1 session of psychoeducation, followed by 5 sessions of Cognitive Behavioral Therapy (CBT) if panic symptoms do not improve at 1-month follow-up.<br>|
| Active Comparator: Screening only<br>Screening only for panic attacks and panic disorder using a gold standard clinical interview that provides coverage of the core symptoms of panic attacks and panic disorder. | Diagnostic Test: Screening only<br>* Screening for probable panic attacks or panic disorder using the Structured Clinical Interview for DSM-5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in panic scores at every 3 months from baseline using the Panic Disorder Severity Scale (PDSS; Shear et al., 2001) | 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. | Baseline, 1st month, 3rd month, 6th month, 12th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form Health Survey (SF-36; Ware & Sherbourne, 1992) | The SF-36 is a reliable and valid 36-item self-report questionnaire that evaluates multiple facets of health-related quality of life. | Baseline, 1st month, 3rd month, 6th month, 12th month | 
| WHO Disability Assessment Schedule (WHO-DAS; World Health Organization, 2010) | The WHO-DAS is a brief, cross-culturally valid, self-report questionnaire that is used to assess overall level of health and disability in clinical and general population settings. | Baseline, 1st month, 3rd month, 6th month, 12th month | 
| Psychiatric Diagnostic Screening Questionnaire (PDSQ; Zimmerman & Mattia, 2001) | The PDSQ is a reliable and valid self-report diagnostic questionnaire that has been widely used to assess the most common psychiatric disorders in outpatient settings. | Baseline, 1st month, 3rd month, 6th month, 12th month | 
| EQ-5D (EuroQol Group, 1990) | The EQ-5D is a patient self-report instrument that evaluates generic quality of life. | Baseline, 1st month, 3rd month, 6th month, 12th month |