Clinical trial NCT03632356: A Multi-Site RCT of a Stepped-Care Intervention for Emergency Department Patients With Panic Attacks and Panic Disorder
Official title: A Multi-Site Randomized Controlled Trial of a Stepped-Care Intervention for Emergency Department Patients With Panic Attacks and Panic Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Panic Attacks and Disorders
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Duke-NUS Graduate Medical School
name: Changi General Hospital
name: National Medical Research Council (NMRC), Singapore
First posted: 2018-08-15
Enrollment: 79
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 stage parallel group multi-site RCT design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in panic scores at every 3 months from baseline using the Panic Disorder Severity Scale (PDSS; Shear et al., 2001)
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
Secondary outcomes:
measure: Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
measure: WHO Disability Assessment Schedule (WHO-DAS; World Health Organization, 2010)
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
measure: Psychiatric Diagnostic Screening Questionnaire (PDSQ; Zimmerman & Mattia, 2001)
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
measure: EQ-5D (EuroQol Group, 1990)
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
Other outcomes:
measure: Clinician Global Impression Severity Scale (CGI; Guy, 2008)
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
measure: Panic Disorder Module of the Structured Clinical Interview for DSM-5 (SCID; First et al., 2015)
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Sharon C Sung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
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.
citation: World Health Organization, Measuring Health and Disability: Manual for WHO Disability Assessment Schedule - WHODAS 2.0, Geneva, 2010.
citation: 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.
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.
citation: 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.