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

Not Applicable

Active, not recruiting

• Conditions: Panic Attacks and Disorders
• Interventions: Behavioral: Stepped Care Intervention (STEP); Diagnostic Test: Screening only

• Registration Number: NCT03632356
• Lead Sponsor: Singapore General Hospital

Brief 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.

Study Timeline

• Study Start: 2018-06-11
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-21
• Primary Completion: 2024-05-31
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stepped Care Intervention (STEP)	Stepped Care Intervention (STEP)	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.
Screening only	Screening only	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
EQ-5D (EuroQol Group, 1990)	Baseline, 1st month, 3rd month, 6th month, 12th month	The EQ-5D is a patient self-report instrument that evaluates generic quality of life.
Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)	Baseline, 1st month, 3rd month, 6th month, 12th month	The SF-36 is a reliable and valid 36-item self-report questionnaire that evaluates multiple facets of health-related quality of life.
WHO Disability Assessment Schedule (WHO-DAS; World Health Organization, 2010)	Baseline, 1st month, 3rd month, 6th month, 12th month	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.
Psychiatric Diagnostic Screening Questionnaire (PDSQ; Zimmerman & Mattia, 2001)	Baseline, 1st month, 3rd month, 6th month, 12th month	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.

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore