Panic Attacks and Disorders
Conditions
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.
Interventions
BEHAVIORALStepped 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_TESTScreening only
Screening for probable panic attacks or panic disorder using the Structured Clinical Interview for DSM-5
Sponsors
Duke-NUS Graduate Medical School
Changi General Hospital
National Medical Research Council (NMRC), Singapore
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
2 stage parallel group multi-site RCT design
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinician Global Impression Severity Scale (CGI; Guy, 2008) | Baseline, 1st month, 3rd month, 6th month, 12th month | 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. |
| Panic Disorder Module of the Structured Clinical Interview for DSM-5 (SCID; First et al., 2015) | Baseline, 1st month, 3rd month, 6th month, 12th month | The SCID is the gold standard tool for the reliable diagnosis of Axis I psychiatric disorders in clinical populations. |
Countries
Singapore
Outcome results
None listed