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

Singapore Health Services (SingHealth)

Status: Active, not recruiting

Conditions: Panic Attacks and Disorders

Treatments: Behavioral: Stepped Care Intervention (STEP); Diagnostic Test: Screening only

Study type: Interventional

Funder types: Other

Identifiers

NCT03632356

2018/2284

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 2 patient groups

Stepped Care Intervention (STEP)

Experimental group

Description:

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.

Treatment:

Behavioral: Stepped Care Intervention (STEP)

Screening only

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Screening only