Panic Attacks and DisordersNCT03632356
A Multi-Site RCT of a Stepped-Care Intervention for Emergency Department Patients With Panic Attacks and Panic Disorder
A study testing Stepped Care Intervention (STEP) and Screening only in people with Panic Attacks and Disorders, run by Singapore General Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Panic Attacks and Disorders
- What is being tested?
- Stepped Care Intervention (STEP) and Screening only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Jun 2018to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Score ≥ 3 on CDR screener
- Diagnosis of panic attack or panic disorder confirmed on SCID interview
- Willing to enter randomized trial
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Site Randomized Controlled Trial of a Stepped-Care Intervention for Emergency Department Patients With Panic Attacks and Panic Disorder
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.
Read the 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.
- Conditions
- Panic Attacks and Disorders
- Being tested
- Stepped Care Intervention (STEP), Screening only
- Medical subject headings
- Panic Disorder, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped Care Intervention (STEP)Behavioural
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 onlyDiagnostic test
Screening for probable panic attacks or panic disorder using the Structured Clinical Interview for DSM-5
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Stepped Care Intervention (STEP) |
| 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. Receives: Diagnostic Test: Screening only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1st month, 3rd month, 6th month, 12th month
Secondary outcomes (4)
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.
Measured: Baseline, 1st month, 3rd month, 6th month, 12th month
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1st month, 3rd month, 6th month, 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start11 Jun 2018
- Primary completion31 May 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Panic Attacks and DisordersStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 stage parallel group multi-site RCT design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, Changi General Hospital, National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
- Investigators
- Sharon C Sung, PhD, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632356
- Sponsor's protocol ID
- 2018/2284
- Status last verified
- Dec 2023
- First submitted
- 6 Aug 2018
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11591432Guy, 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.
PubMed 1593914World 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.
PubMed 10109801Sung 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.
PubMed 29320381Zimmerman 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.
PubMed 11483146Sung 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.
PubMed 36527018
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Randomized Controlled Trial of a Stepped-Care Intervention for Emergency Department Patients With Panic Attacks and Panic Disorder
- ClinicalTrials.gov ID
- NCT03632356
- Acronym / sponsor ID
- 2018/2284
- Conditions
- Panic Attacks and Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, Changi General Hospital, National Medical Research Council (NMRC), Singapore
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 stage parallel group multi-site RCT design
| Arm | Type | Receives |
|---|---|---|
| Stepped Care Intervention (STEP) | Experimental | Behavioral: 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. |
| Screening only | Active comparator | Diagnostic Test: Screening onlyScreening 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Stepped Care Intervention (STEP) |
| Screening onlyScreening for probable panic attacks or panic disorder using the Structured Clinical Interview for DSM-5 | Diagnostic test | Screening only |
Primary outcome
Change in panic scores at every 3 months from baseline using the Panic Disorder Severity Scale (PDSS; Shear et al., 2001)
Time frame: 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.
4 secondary outcomes
Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)
Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month
WHO Disability Assessment Schedule (WHO-DAS; World Health Organization, 2010)
Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month
Psychiatric Diagnostic Screening Questionnaire (PDSQ; Zimmerman & Mattia, 2001)
Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month
EQ-5D (EuroQol Group, 1990)
Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Background: PubMed 11591432Shear 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.
- BackgroundGuy, 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.
- BackgroundFirst, 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.
- Background: PubMed 1593914Ware 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.
- BackgroundWorld Health Organization, Measuring Health and Disability: Manual for WHO Disability Assessment Schedule - WHODAS 2.0, Geneva, 2010.
- Background: PubMed 10109801EuroQol 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.
- Background: PubMed 29320381Sung 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.
- Background: PubMed 11483146Zimmerman 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.
- Derived from this study: PubMed 36527018Sung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon C Sung, PhD principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Care Intervention (STEP) and Screening only in people with Panic Attacks and Disorders, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in panic scores at every 3 months from baseline using the Panic Disorder Severity Scale (PDSS; Shear et al., 2001) (time frame: Baseline, 1st month, 3rd month, 6th month, 12th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03632356, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.