Plain English Summary
Not provided at time of registration
Trial website
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list