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 design	Randomised, controlled, parallel group, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title	Group training for hepatitis C patients to improve quality of life
Study acronym	Intervention for hepatitis C patients
Study objectives	Problem 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) studied	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
Primary outcome measure	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 study start date	01/03/2007
Completion date	31/08/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	300
Key inclusion criteria	1. Hepatitis C 2. Age 18 years or older
Key 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
Date of first enrolment	01/03/2007
Date of final enrolment	31/08/2008

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"	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 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

Editorial Notes

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