Group training for hepatitis C patients to improve quality of life

ISRCTN ISRCTN58830535
DOI https://doi.org/10.1186/ISRCTN58830535
Secondary identifying numbers NL920 (NTR944)
Submission date
02/05/2007
Registration date
02/05/2007
Last edited
23/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
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

Contact information

Ms A. Beerthuizen
Scientific

Erasmus Medical Centre
Department of Psychiatry and Psychotherapy
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone +31 (0)10 408 8234
Email a.beerthuizen@erasmusmc.nl

Study information

Study designRandomised, controlled, parallel group, multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific titleGroup training for hepatitis C patients to improve quality of life
Study acronymIntervention for hepatitis C patients
Study objectivesProblem solving therapy improves the quality of life in patients with hepatitis C.
Ethics approval(s)Approval received from the Medical Ethical Board of the Erasmus MC on the 22nd of February 2007 (ref: MEC-2007-001).
Health condition(s) or problem(s) studiedHepatitis C patients' quality of life
Intervention150 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 typeOther
Primary outcome measureQuality 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 measures1. 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 study start date01/03/2007
Completion date31/08/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants300
Key inclusion criteria1. Hepatitis C
2. Age 18 years or older
Key exclusion criteria1. 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
Date of first enrolment01/03/2007
Date of final enrolment31/08/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands

Sponsor information

Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre

Department of Medical Psychology and Psychotherapy
P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Website http://www.erasmusmc.nl/content/englishindex.htm
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Government

Health Insurance Company Nuts Ohra (Stichting Nuts Ohra) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

23/09/2021: Proactive update review. No publications found. Search options exhausted.