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

Singapore General Hospital79 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Panic Attacks and Disorders

Interventions

Stepped Care Intervention (STEP)BEHAVIORAL

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.

Screening onlyDIAGNOSTIC_TEST

Screening for probable panic attacks or panic disorder using the Structured Clinical Interview for DSM-5

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female 2. 21+ years of age 3. Triage level 2 or 3 4. English or Mandarin speaking 5. Able to provide informed consent and read study materials 6. Presenting complaint of chest pain, palpitations, dizziness, or difficulty breathing 7. Score ≥ 3 on CDR screener 8. Diagnosis of panic attack or panic disorder confirmed on SCID interview 9. Willing to enter randomized trial Exclusion Criteria: 1. Altered mental status (dementia, psychosis, substance intoxication/withdrawal) 2. Triage level 1 3. Non-English or Mandarin speaking 4. Unwilling or unable to complete study procedures 5. Symptoms of clear cardiac origin as determined by A\&E physician 6. Deemed unfit due to possible adverse respiratory or cardiac outcomes by A\&E physician 7. Clear organic cause for panic symptoms as evidenced by laboratory tests (FBC, UE, ECG, TROPONIN T, CXR) 8. Does not meet criteria for panic attack or panic disorder on SCID interview 9. 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)

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.