A Multi-Site RCT of a Stepped-Care Intervention for Emergency Department Patients With Panic Attacks and Panic Disorder
NCT ID: NCT03632356
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
79 participants
INTERVENTIONAL
2018-06-11
2024-11-30
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
Screening only
Screening for probable panic attacks or panic disorder using the Structured Clinical Interview for DSM-5
Interventions
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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.
Screening only
Screening for probable panic attacks or panic disorder using the Structured Clinical Interview for DSM-5
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
ALL
No
Sponsors
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Duke-NUS Graduate Medical School
OTHER
Changi General Hospital
OTHER
National Medical Research Council (NMRC), Singapore
OTHER_GOV
Singapore General Hospital
OTHER
Responsible Party
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Principal Investigators
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Sharon C Sung, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke-NUS Graduate Medical School
Locations
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Singapore General Hospital
Singapore, , Singapore
Countries
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References
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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.
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.
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.
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.
World Health Organization, Measuring Health and Disability: Manual for WHO Disability Assessment Schedule - WHODAS 2.0, Geneva, 2010.
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.
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.
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.
Sung SC, Lim L, Lim SH, Finkelstein EA, Chin SLH, Annathurai A, Chakraborty B, Strauman TJ, Pollack MH, Ong MEH. Protocol for a multi-site randomized controlled trial of a stepped-care intervention for emergency department patients with panic-related anxiety. BMC Psychiatry. 2022 Dec 16;22(1):795. doi: 10.1186/s12888-022-04387-z.
Other Identifiers
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2018/2284
Identifier Type: -
Identifier Source: org_study_id