Randomised EXhaustion Intervention Trial

ISRCTN	ISRCTN98393380
DOI	https://doi.org/10.1186/ISRCTN98393380
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof J K L Denollet
Scientific

Tilburg University
Department of Psychology and Health
P.O. Box 90153
Tilburg
5000 LE
Netherlands

Phone	+31 (0)13 466 2390
Email	denollet@uvt.nl

Study design	Multicentre, randomised, placebo controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Effects of treating exhaustion in angioplasty patients on new coronary events: results of the randomised exhaustion intervention trial
Study acronym	EXIT
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
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 study start date	01/07/1996
Completion date	30/04/2001

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	710
Key inclusion criteria	Exhausted patients being treated successfully with PCI (reduction in stenosis of greater than 50%).
Key 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
Date of first enrolment	01/07/1996
Date of final enrolment	30/04/2001

Tilburg University

Tilburg
5000 LE
Netherlands

Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)
Research organisation

P.O. Box 300
The Hague
2501 CH
Netherlands

Not defined

Not provided at time of registration

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan