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Non Cardiac Chest Pain and Benign Palpitations

Primary Purpose

Anxiety/Depression in Cardiological Unit

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Cognitive behaviour therapy
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety/Depression in Cardiological Unit focused on measuring anxiety, panic disorder, chest pain, palpitations

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • investigated for chest pain or palpitation 6 month ago at Cardiological Out-patient Clinic, Molde Hospital
  • suffer of chest pain or palpitations

Exclusion Criteria:

  • do not speak norwegian properly
  • mentally retarded
  • psychosis last 6 month
  • current alcohol or drug misuse

Sites / Locations

  • Cardiological Out-patient Clinic

Outcomes

Primary Outcome Measures

Body sensation questionnaire (BSQ)
Beck Depression Inventory (BDI)

Secondary Outcome Measures

Full Information

First Posted
February 14, 2008
Last Updated
August 25, 2011
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00623454
Brief Title
Non Cardiac Chest Pain and Benign Palpitations
Official Title
A Randomized Controlled Trial of Cognitive Behavioural Therapy for Non-cardiac Chest Pain and Palpitations.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
All Patients between 18 and 65 years are asked 6 month after investigation for chest pain or palpitation at Cardiological Out-patient Clinic, Molde Hospital, about if they still have symptoms of chest pain or palpitation. If they still have some of the symptoms they are invited to participate in a coping course to learn a better way to deal with their symptoms. The coping course consist of three sessions of cognitive behaviour therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety/Depression in Cardiological Unit
Keywords
anxiety, panic disorder, chest pain, palpitations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cognitive behaviour therapy
Intervention Description
Three hours with cognitive therapy focusing on the chest pain and palpitations.
Primary Outcome Measure Information:
Title
Body sensation questionnaire (BSQ)
Time Frame
end of treatment, after 3 month and after 12 month
Title
Beck Depression Inventory (BDI)
Time Frame
end of treatment, after 3 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: investigated for chest pain or palpitation 6 month ago at Cardiological Out-patient Clinic, Molde Hospital suffer of chest pain or palpitations Exclusion Criteria: do not speak norwegian properly mentally retarded psychosis last 6 month current alcohol or drug misuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egil Jonsbu, MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiological Out-patient Clinic
City
Molde
ZIP/Postal Code
6400
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20633745
Citation
Jonsbu E, Dammen T, Morken G, Martinsen EW. Patients with noncardiac chest pain and benign palpitations referred for cardiac outpatient investigation: a 6-month follow-up. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):406-12. doi: 10.1016/j.genhosppsych.2010.03.003. Epub 2010 Apr 13.
Results Reference
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Non Cardiac Chest Pain and Benign Palpitations

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