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

Panic Attacks and Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03632356
• Other study ID #: 2018/2284
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: November 30, 2024

Study information

• Verified date: December 2023
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 79
• Est. completion date: November 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Panic Attacks and Disorders
• Panic Disorder

Intervention

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

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
Singapore General Hospital	Changi General Hospital, Duke-NUS Graduate Medical School, National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (8)

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9. — View Citation

First, M. B., Williams, J. B. W., Karg, R. S. and Spitzer, R. L., Structured Clinical Interview for DSM-5 Disorders-Clinician Version (SCID-5-CV), Arlington, VA: American Psychiatric Association, 2015.

Guy, W., Clinical Global Impressions (CGI) Scale., In: Rush, A. J., First, M. B. and Blacker, D. (eds), Handbook of Psychiatric Measures, Washington, D.C.: American Psychiatric Publishing, Inc., 2008.

Shear MK, Rucci P, Williams J, Frank E, Grochocinski V, Vander Bilt J, Houck P, Wang T. Reliability and validity of the Panic Disorder Severity Scale: replication and extension. J Psychiatr Res. 2001 Sep-Oct;35(5):293-6. doi: 10.1016/s0022-3956(01)00028-0. — View Citation

Sung SC, Rush AJ, Earnest A, Lim LEC, Pek MPP, Choi JMF, Ng MPK, Ong MEH. A Brief Interview to Detect Panic Attacks and Panic Disorder in Emergency Department Patients with Cardiopulmonary Complaints. J Psychiatr Pract. 2018 Jan;24(1):32-44. doi: 10.1097/PRA.0000000000000283. — View Citation

Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. — View Citation

World Health Organization, Measuring Health and Disability: Manual for WHO Disability Assessment Schedule - WHODAS 2.0, Geneva, 2010.

Zimmerman M, Mattia JI. A self-report scale to help make psychiatric diagnoses: the Psychiatric Diagnostic Screening Questionnaire. Arch Gen Psychiatry. 2001 Aug;58(8):787-94. doi: 10.1001/archpsyc.58.8.787. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinician Global Impression Severity Scale (CGI; Guy, 2008)	The CGI is a clinician-rated instrument used to assess global severity of symptoms.The CGI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher total value indicates more severe panic symptoms and anxiety.	Baseline, 1st month, 3rd month, 6th month, 12th month
Other	Panic Disorder Module of the Structured Clinical Interview for DSM-5 (SCID; First et al., 2015)	The SCID is the gold standard tool for the reliable diagnosis of Axis I psychiatric disorders in clinical populations.	Baseline, 1st month, 3rd month, 6th month, 12th month
Primary	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.	Baseline, 1st month, 3rd month, 6th month, 12th month
Secondary	Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)	The SF-36 is a reliable and valid 36-item self-report questionnaire that evaluates multiple facets of health-related quality of life.	Baseline, 1st month, 3rd month, 6th month, 12th month
Secondary	WHO Disability Assessment Schedule (WHO-DAS; World Health Organization, 2010)	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.	Baseline, 1st month, 3rd month, 6th month, 12th month
Secondary	Psychiatric Diagnostic Screening Questionnaire (PDSQ; Zimmerman & Mattia, 2001)	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.	Baseline, 1st month, 3rd month, 6th month, 12th month
Secondary	EQ-5D (EuroQol Group, 1990)	The EQ-5D is a patient self-report instrument that evaluates generic quality of life.	Baseline, 1st month, 3rd month, 6th month, 12th month