Contact information
Type
Scientific
Primary contact
Ms A. Beerthuizen
ORCID ID
Contact details
Erasmus Medical Centre
Department of Psychiatry and Psychotherapy
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 408 8234
a.beerthuizen@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Intervention for hepatitis C patients
Study hypothesis
Problem solving therapy improves the quality of life in patients with hepatitis C.
Ethics approval
Approval received from the Medical Ethical Board of the Erasmus MC on the 22nd of February 2007 (ref: MEC-2007-001).
Study design
Randomised, controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Hepatitis C patients' quality of life
Intervention
150 patients will participate in a group training (problem solving therapy), to improve quality of life by teaching patients skills that aid in coping with the consequences of the disease. This training consists of eight sessions of two hours.
To evaluate this training, participants as well as the 150 controls will complete a questionnaire before the start of the training, right after and six months after the training. When the intervention is effective, controls will participate in this training after the end of this research project.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Quality of life (36-item Short Form [SF-36] questionnaire); the participants will complete this questionnaire at baseline, T1 (right after the training) and at T2 (six months after the last session of the training).
Secondary outcome measures
1. Health status (European Quality of Life [EuroQoL-5D] questionnaire)
2. Health & Labour Questionnaire
3. Depression (Beck Depression Inventory [BDI])
4. Problem orientation and problem solving skills (Social Problem Solving Inventory [SPSI])
The participants will complete these questionnaires at baseline, T1 and T2 (see primary outcome).
Overall trial start date
01/03/2007
Overall trial end date
31/08/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Hepatitis C
2. Age 18 years or older
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
300
Participant exclusion criteria
1. Patients with an insufficient grasp of the Dutch language to be able to participate in a training project
2. Patients with a psychiatric illness
3. Patients who are/have been succesfully treated with interferon
Recruitment start date
01/03/2007
Recruitment end date
31/08/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
Department of Medical Psychology and Psychotherapy
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Health Insurance Company Nuts Ohra (Stichting Nuts Ohra) (The Netherlands)
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