Condition category
Infections and Infestations
Date applied
23/10/2015
Date assigned
03/11/2015
Last edited
03/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hepatitis is a disease which causes inflammation (swelling) of the liver, which is caused by a viral infection or long-term alcohol abuse. Hepatitis C is the most common type of viral hepatitis. In an infected person, the hepatitis C virus is particularly concentrated in the blood, and so it can is easily spread through blood-to-blood contact, such as sharing needles amongst drug abusers or receiving contaminated blood products in hospital. In the early stages (acute hepatitis) a person often has no symptoms, and so does not know that they are infected. This means that about 80% of infections are able to move to the long-lasting stage. Chronic hepatitis C (CHC) is where a person has been infected for more than six months. Sufferers tend to feel extremely tired, achy and generally unwell. Left untreated, the infection causes the liver to become irreversibly scarred (cirrhosis) which can lead to liver failure. Many studies have shown that people suffering from CHC have a lower quality of life than a healthy person. As well as the physical symptoms, more than a third of people with CHC suffer from mental health problems such as anxiety and depression, which many find difficult to cope with. Problem solving therapy (PST) is a type of talking therapy which has been very effective in treating depression. It aims to teach people how to identify and solve their own problems without becoming stressed or upset. The aim of this study is to find out if PST can help improve the quality of life in patients suffering from CHC.

Who can participate?
Adults with a chronic hepatitis C infection.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in weekly sessions of PST for seven weeks. During these sessions, participants are given a chance to talk about problems they experience in their day-to-day life and are taught techniques to help them solve these problems when they next face them. Participants in the second group are placed on a waiting list for the PST and do not receive any therapy. At the start of the study, after the final session and 6 months later, participants in both groups are asked to fill out a questionnaire to find out how they are coping and whether their quality of life has improved. After the final testing point (6 months after the last PST session), participants in the second group are given the chance to take part in PST.

What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their quality of life. There are no risks of taking part in the study.

Where is the study run from?
Erasmus MC and seven other hospitals in the Netherlands.

When is the study starting and how long is it expected to run for?
March 2007 to September 2010

Who is funding the study?
1. NutsOhra (Netherlands)
2. The Stomach-Liver-Bowel Foundation (Netherlands)

Who is the main contact?
Dr Annemerle Beerthuizen

Trial website

Contact information

Type

Scientific

Primary contact

Dr Annemerle Beerthuizen

ORCID ID

http://orcid.org/0000-0002-0468-4601

Contact details

Department of Psychiatry
Room Na-2011
Wytemaweg 80
Rotterdam
3015 CN
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Problem solving therapy for patients with hepatitis C to improve quality of life

Acronym

Study hypothesis

Problem solving therapy will improve the quality of life of patients with hepatitis C.

Ethics approval

Medical Ethical Committee of the Erasmus MC (Netherlands), 22/02/2007, ref: MEC-2007-001

Study design

Multi-centre randomised wait-list controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Chronic hepatitis C

Intervention

The participants are randomly allocated to one of two groups.

Group 1: Participants take part in seven 1.5-hour sessions of problem solving therapy (PST). PST involves a training in systematic problem solving skills. During training, patients discuss practical problems in daily life and use a standardized way of generating solutions for these problems. This discussion is facilitated by a trained psychologist. At the end of the last session the participants were given the second questionnaire that had to be filled in and sent back to the researcher within one week.

Group 2: Participants are placed on a waiting list for the duration of the study. Participants who are wait-list controlled are given the opportunity to take part in the intervention after the study is complete.

All participants in both groups are asked to fill out a questionnaire on quality of life at three moments of measurements: baseline just before the start of the first training session, right after the last session (7 weeks) and 6 months later.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Quality of life measured using the Short Form Health Survey (SF-36) at baseline, after the last session (7 weeks), and 6 months after the intervention.

Secondary outcome measures

1. Liver disease symptoms measured using the Liver Disease Symptom Index (LDSI) at baseline, after the last session (7 weeks), and 6 months after the intervention
2. Depression measured using the Beck Depression Inventory (BDI) at baseline, after the last session (7 weeks), and 6 months after the intervention
3. Health care utilisation and production loss measured using the Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P) at baseline, after the last session (7 weeks), and 6 months after the intervention

Overall trial start date

01/03/2007

Overall trial end date

01/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Chronic hepatitis C

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Experimental group: 150, wait list control group: 150

Participant exclusion criteria

1. Unable to fill out a questionnaire (e.g. because of language problems or cognitive impairment)
2. Patients with a psychiatric disorder
3. Patients who are being treated with Interferon

Recruitment start date

01/05/2007

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus MC
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Trial participating centre

Reinier de Graaf Hospital (Reinier de Graaf Gasthuis)
Reinier de Graafweg 5
Delft
2625 AD
Netherlands

Trial participating centre

Gelre Hospital Apeldoorn (Gelre Ziekenhuizen Apeldoorn)
Albert Schweitzerlaan 31
Apeldoorn
7334 DZ
Netherlands

Trial participating centre

Deventer Hospital (Deventer Ziekenhuis)
Nico Bolkesteinlaan 75
Deventer
7416 SE
Netherlands

Trial participating centre

Academic Medical Center
Meibergdreef 9
Amsterdam Zuid-Oost
1105 AZ
Netherlands

Trial participating centre

Haga Hospital (Haga Ziekenhuis)
Leyweg 275
Den Haag
2545 CH
Netherlands

Trial participating centre

VU University Medical Center
De Boelelaan 1118
Amsterdam
1081 HV
Netherlands

Trial participating centre

OLVG Hospital
Oosterpark 9
Amsterdam
1091 AC

Sponsor information

Organisation

Erasmus MC

Sponsor details

Medical Psychology section
Wytemaweg 80
Rotterdam
3015 CN
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

NutsOhra

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Stomach-Liver-Bowel Foundation (Maag Lever Darm Stichting)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

31/01/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes