Condition category
Infections and Infestations
Date applied
02/05/2007
Date assigned
02/05/2007
Last edited
03/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.erasmusmc.nl/content/englishindex.htm

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

Publication citations

Additional files

Editorial Notes