NCT03632356

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Panic Attacks and Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Stepped Care Intervention (STEP)	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.
DIAGNOSTIC_TEST	Screening only	Screening for probable panic attacks or panic disorder using the Structured Clinical Interview for DSM-5

Timeline

• Start date: 2018-06-11
• Primary completion: 2024-05-31
• Completion: 2024-11-30
• First posted: 2018-08-15
• Last updated: 2023-12-21

Locations

1 site across 1 country: Singapore