Condition category
Signs and Symptoms
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
03/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.cpsych.org.uk/VE/therapy.htm

Contact information

Type

Scientific

Primary contact

Prof J K L Denollet

ORCID ID

Contact details

Tilburg University
Department of Psychology and Health
P.O. Box 90153
Tilburg
5000 LE
Netherlands
+31 (0)13 466 2390
denollet@uvt.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of treating exhaustion in angioplasty patients on new coronary events: results of the randomised exhaustion intervention trial

Acronym

EXIT

Study hypothesis

Behavioural intervention in exhausted patients post-percutaneous coronary intervention (PCI) is hypothesised to reduce exhaustion and depression, improve quality of life, and improve prognosis.

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, randomised, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Percutaneous coronary intervention (PCI), exhaustion

Intervention

1. Behavioural intervention including relaxation therapy
2. Usual care

Secondary sponsor details:
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
P.O. Box 93245
Den Haag
2509 AE
Netherlands
Email: info@zonmw.nl
Sponsor website: http://www.zonmw.nl

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Exhaustion
2. New coronary event
3. 'De novo' lesions

All at 18 months follow-up.

Secondary outcome measures

1. New coronary events (less than 6 months)
2. Late coronary events (greater than 6 months)

Overall trial start date

01/07/1996

Overall trial end date

30/04/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Exhausted patients being treated successfully with PCI (reduction in stenosis of greater than 50%).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

710

Participant exclusion criteria

1. Severe somatic or mental comorbidity
2. Somtisation disorder, fibromyalgia or chronic fatigue
3. Participation in a behavioural, rehabilitation program other than EXIT
4. Unsuccessful treatment for a recent depression or panic disorder
5. Inability to speak Dutch

Recruitment start date

01/07/1996

Recruitment end date

30/04/2001

Locations

Countries of recruitment

Netherlands

Trial participating centre

Tilburg University
Tilburg
5000 LE
Netherlands

Sponsor information

Organisation

Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)

Sponsor details

P.O. Box 300
The Hague
2501 CH
Netherlands
+31 (0)70 315 5555
info@hartstichting.nl

Sponsor type

Research organisation

Website

http://www.hartstichting.nl

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes