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Treatment of Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain (MADONA)

Primary Purpose

Panic Disorder, Anxiety Disorder, Mental Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Brief cognitive-behavioral treatment for Panic Disorder
Cognitive-Behavior Therapy for Panic Disorder
paroxetine
Sponsored by
Université du Québec a Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring Panic Disorder, anxiety, chest pain, emergency department, cognitive-behavioral treatment

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 18 and over
  • Mastered oral and written French
  • Consulted an emergency department for chest pain with very low risk of coronary disease (normal ECG and blood tests)
  • Met criteria for Panic Disorder

Exclusion Criteria:

  • Chest pain with an obvious medical origin (obvious trauma or abnormal pulmonary x-rays)
  • Had received cognitive-behavior therapy for Panic Disorder in the last six months
  • Cognitive impairment preventing the completion of psychological assessment
  • Past or present psychotic episode, Bipolar Disorder, or organic mental disorder
  • Current Abuse or Dependence Disorder
  • If another Mental Disorder is present, its severity was equal or inferior to the severity of Panic Disorder
  • Current medical condition preventing the participant from receiving pharmacological of cognitive-behavior treatment

Sites / Locations

  • Hôtel-Dieu de LévisRecruiting
  • Institut de Cardiologie de Montréal (Montreal Heart Institute)Recruiting
  • Hôpital du Sacré-Coeur de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Panic Disorder diagnosis

Secondary Outcome Measures

Panic symptomatology, psychological distress, quality of life, and use of health services

Full Information

First Posted
August 14, 2008
Last Updated
August 14, 2008
Sponsor
Université du Québec a Montréal
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00736346
Brief Title
Treatment of Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain
Acronym
MADONA
Official Title
Efficacy of Three Treatment Modalities for Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Université du Québec a Montréal
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the impact of three different treatment modalities on panic symptoms, quality of life and use of health services among individuals consulting an emergency department for non cardiac chest pain and having Panic Disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder, Anxiety Disorder, Mental Disorder
Keywords
Panic Disorder, anxiety, chest pain, emergency department, cognitive-behavioral treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Brief cognitive-behavioral treatment for Panic Disorder
Intervention Description
One two-hour session of cognitive-behavior therapy for panic disorder
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavior Therapy for Panic Disorder
Intervention Description
Seven one-hour sessions of cognitive-behavior therapy for panic disorder
Intervention Type
Drug
Intervention Name(s)
paroxetine
Intervention Description
40 mg die, for 6 months
Primary Outcome Measure Information:
Title
Panic Disorder diagnosis
Time Frame
Pre and posttreatment, and 3, 6 and 12 months after treament
Secondary Outcome Measure Information:
Title
Panic symptomatology, psychological distress, quality of life, and use of health services
Time Frame
Pre and posttreatment, and 3, 6 and 12 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 and over Mastered oral and written French Consulted an emergency department for chest pain with very low risk of coronary disease (normal ECG and blood tests) Met criteria for Panic Disorder Exclusion Criteria: Chest pain with an obvious medical origin (obvious trauma or abnormal pulmonary x-rays) Had received cognitive-behavior therapy for Panic Disorder in the last six months Cognitive impairment preventing the completion of psychological assessment Past or present psychotic episode, Bipolar Disorder, or organic mental disorder Current Abuse or Dependence Disorder If another Mental Disorder is present, its severity was equal or inferior to the severity of Panic Disorder Current medical condition preventing the participant from receiving pharmacological of cognitive-behavior treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
André Marchand, PhD
Phone
1 (514) 987-3000
Ext
8439
Email
marchand.andre@uqam.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Geneviève Belleville, PhD
Email
belleville.genevieve@uqam.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Marchand, PhD
Organizational Affiliation
Université du Québec a Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôtel-Dieu de Lévis
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Poitras, MD
Facility Name
Institut de Cardiologie de Montréal (Montreal Heart Institute)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Vadeboncoeur, MD
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc Chauny, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
27777612
Citation
Foldes-Busque G, Hamel S, Belleville G, Fleet R, Poitras J, Chauny JM, Vadeboncoeur A, Lavoie KL, Marchand A. Factors associated with pain level in non-cardiac chest pain patients with comorbid panic disorder. Biopsychosoc Med. 2016 Oct 18;10:30. doi: 10.1186/s13030-016-0081-5. eCollection 2016.
Results Reference
derived

Learn more about this trial

Treatment of Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain

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