Non Cardiac Chest Pain and Benign Palpitations | NCT00623454

Studies
Non Cardiac Chest Pain and Benign Palpitations

NCT00623454

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Aug 29, 2011Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Anxiety/Depression in Cardiological Unit

Interventions

Cognitive behaviour therapy

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Feb 14, 2008

First Submission Date that Met QC Criteria

Feb 14, 2008

First Posted Date

Feb 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2011

Last Update Posted Date

Aug 29, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive behaviour therapy	Behavioral	Three hours with cognitive therapy focusing on the chest pain and palpitations.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body sensation questionnaire (BSQ)		end of treatment, after 3 month and after 12 month
Beck Depression Inventory (BDI)		end of treatment, after 3 and 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Egil Jonsbu, MD	Norwegian University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiological Out-patient Clinic		Molde	Molde	6400	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20633745	Result	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.

ID	Term
D001008	Anxiety Disorders
D016584	Panic Disorder
D002637	Chest Pain

ID	Term
D001523	Mental Disorders
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities