search
Back to results

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

Primary Purpose

Panic Attacks and Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Stepped Care Intervention (STEP)
Screening only
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Attacks and Disorders

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Singapore General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stepped Care Intervention (STEP)

Screening only

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
EQ-5D (EuroQol Group, 1990)
The EQ-5D is a patient self-report instrument that evaluates generic quality of life.

Full Information

First Posted
August 6, 2018
Last Updated
May 4, 2022
Sponsor
Singapore General Hospital
Collaborators
Duke-NUS Graduate Medical School, Changi General Hospital, National Medical Research Council (NMRC), Singapore
search

1. Study Identification

Unique Protocol Identification Number
NCT03632356
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
June 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Duke-NUS Graduate Medical School, Changi General Hospital, National Medical Research Council (NMRC), Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Attacks and Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 stage parallel group multi-site RCT design
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stepped Care Intervention (STEP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Screening only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stepped Care Intervention (STEP)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Screening only
Intervention Description
Screening for probable panic attacks or panic disorder using the Structured Clinical Interview for DSM-5
Primary Outcome Measure Information:
Title
Change in panic scores at every 3 months from baseline using the Panic Disorder Severity Scale (PDSS; Shear et al., 2001)
Description
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.
Time Frame
Baseline, 1st month, 3rd month, 6th month, 12th month
Secondary Outcome Measure Information:
Title
Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)
Description
The SF-36 is a reliable and valid 36-item self-report questionnaire that evaluates multiple facets of health-related quality of life.
Time Frame
Baseline, 1st month, 3rd month, 6th month, 12th month
Title
WHO Disability Assessment Schedule (WHO-DAS; World Health Organization, 2010)
Description
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.
Time Frame
Baseline, 1st month, 3rd month, 6th month, 12th month
Title
Psychiatric Diagnostic Screening Questionnaire (PDSQ; Zimmerman & Mattia, 2001)
Description
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.
Time Frame
Baseline, 1st month, 3rd month, 6th month, 12th month
Title
EQ-5D (EuroQol Group, 1990)
Description
The EQ-5D is a patient self-report instrument that evaluates generic quality of life.
Time Frame
Baseline, 1st month, 3rd month, 6th month, 12th month
Other Pre-specified Outcome Measures:
Title
Clinician Global Impression Severity Scale (CGI; Guy, 2008)
Description
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.
Time Frame
Baseline, 1st month, 3rd month, 6th month, 12th month
Title
Panic Disorder Module of the Structured Clinical Interview for DSM-5 (SCID; First et al., 2015)
Description
The SCID is the gold standard tool for the reliable diagnosis of Axis I psychiatric disorders in clinical populations.
Time Frame
Baseline, 1st month, 3rd month, 6th month, 12th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female 21+ years of age Triage level 2 or 3 English or Mandarin speaking Able to provide informed consent and read study materials Presenting complaint of chest pain, palpitations, dizziness, or difficulty breathing Score ≥ 3 on CDR screener Diagnosis of panic attack or panic disorder confirmed on SCID interview Willing to enter randomized trial Exclusion Criteria: Altered mental status (dementia, psychosis, substance intoxication/withdrawal) Triage level 1 Non-English or Mandarin speaking Unwilling or unable to complete study procedures Symptoms of clear cardiac origin as determined by A&E physician Deemed unfit due to possible adverse respiratory or cardiac outcomes by A&E physician Clear organic cause for panic symptoms as evidenced by laboratory tests (FBC, UE, ECG, TROPONIN T, CXR) Does not meet criteria for panic attack or panic disorder on SCID interview Received CBT for panic symptoms in previous 12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon C Sung, PhD
Phone
(65) 6576 7365
Email
sharon.sung@duke-nus.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon C Sung, PhD
Organizational Affiliation
Duke-NUS Graduate Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angeline Chen

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11591432
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
1593914
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.
Results Reference
background
Citation
World Health Organization, Measuring Health and Disability: Manual for WHO Disability Assessment Schedule - WHODAS 2.0, Geneva, 2010.
Results Reference
background
PubMed Identifier
10109801
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.
Results Reference
background
PubMed Identifier
29320381
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.
Results Reference
background
PubMed Identifier
11483146
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs