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

  • STATUS
    Recruiting
  • End date
    Jun 28, 2023
  • participants needed
    212
  • sponsor
    Singapore General Hospital
Updated on 18 May 2022

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.

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.

Details
Condition Panic Attacks and Disorders
Treatment Screening Only, Stepped Care Intervention (STEP)
Clinical Study IdentifierNCT03632356
SponsorSingapore General Hospital
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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