NCT00736346

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 15, 2008

Status Verified

August 1, 2008

Enrollment Period

4.2 years

First QC Date

August 14, 2008

Last Update Submit

August 14, 2008

Conditions

Panic DisorderAnxiety DisorderMental Disorder

Keywords

Panic Disorderanxietychest painemergency departmentcognitive-behavioral treatment

Outcome Measures

Primary Outcomes (1)

  • Panic Disorder diagnosis

    Pre and posttreatment, and 3, 6 and 12 months after treament

Secondary Outcomes (1)

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

    Pre and posttreatment, and 3, 6 and 12 months after treatment

Study Arms (4)

1

ACTIVE COMPARATOR
Behavioral: Brief cognitive-behavioral treatment for Panic Disorder

2

ACTIVE COMPARATOR
Behavioral: Cognitive-Behavior Therapy for Panic Disorder

3

ACTIVE COMPARATOR
Drug: paroxetine

4

NO INTERVENTION

Interventions

Brief cognitive-behavioral treatment for Panic DisorderBEHAVIORAL

One two-hour session of cognitive-behavior therapy for panic disorder

1
Cognitive-Behavior Therapy for Panic DisorderBEHAVIORAL

Seven one-hour sessions of cognitive-behavior therapy for panic disorder

2
paroxetineDRUG

40 mg die, for 6 months

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôtel-Dieu de Lévis

Lévis, Quebec, G6V 3Z1, Canada

RECRUITING

Institut de Cardiologie de Montréal (Montreal Heart Institute)

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27777612DERIVED

MeSH Terms

Conditions

Panic DisorderAnxiety DisordersMental DisordersChest PainEmergencies

Interventions

Cognitive Behavioral TherapyParoxetine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • André Marchand, PhD

    Université du Québec a Montréal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

André Marchand, PhD

CONTACT

1 (514) 987-3000marchand.andre@uqam.ca

Geneviève Belleville, PhD

CONTACT

belleville.genevieve@uqam.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 15, 2008

Study Start

October 1, 2005

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

August 15, 2008

Record last verified: 2008-08

Locations

CA(3)