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| Name | Class |
|---|---|
| Duke-NUS Graduate Medical School | OTHER |
| Changi General Hospital | OTHER |
| National Medical Research Council (NMRC), Singapore | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepped Care Intervention (STEP) | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped Care Intervention (STEP) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| WHO Disability Assessment Schedule (WHO-DAS; World Health Organization, 2010) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon C Sung, PhD | Duke-NUS Graduate Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11591432 | Background | 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. | |
| Background | 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. | ||
| Background | 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. | ||
| 1593914 |
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| ID | Term |
|---|---|
| D016584 | Panic Disorder |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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2 stage parallel group multi-site RCT design
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| Screening only | Diagnostic Test | Screening for probable panic attacks or panic disorder using the Structured Clinical Interview for DSM-5 |
|
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 |
| 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 |
| 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 |
| 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 |
| Background |
| 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. |
| Background | World Health Organization, Measuring Health and Disability: Manual for WHO Disability Assessment Schedule - WHODAS 2.0, Geneva, 2010. |
| 10109801 | Background | 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. |
| 29320381 | Background | 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. |
| 11483146 | Background | 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. |
| 36527018 | Derived | 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. |