Mood and Hepatitis C treatment
Research type
Research Study
Full title
Major Depressive Disorder and hepatitis C therapy in a large cohort of hepatitis C infection
IRAS ID
148694
Contact name
Renata Fialho
Contact email
Sponsor organisation
Sussex University
Research summary
High rates of depression during hepatitis C treatment are therefore common and a significant cause of treatment interruption that can have a negative effect on quality of life, recovery rate and long-term medical prognosis [Dieperink et al 2000, Dwight et al, 2000]. Understanding potential vulnerability factors to such depression emergence is therefore of a potential clinical value and may enable more effective interventions for depression, support adherence to antiviral therapy and thereby improve overall outcome.
The aim of this study is to expand the knowledge of baseline clinical vulnerability characteristics to depression in all patients undergoing hepatitis C treatment at Digestive Unit Clinic at the Brighton Sussex University Hospital (BSUH) from 2008 to 2016.
Issues arising from this study are recruitment, inclusion criteria and confidentiality.
Recruitment: The data analysed will be collected as part of a routine diagnosis and treatment as per current clinical standards. Due to the nature of the study we will seek information consent. We will inform the patients that a study is being performed aiming to assess the Hepatitis C treatment outcomes (participant information sheet) and ask them if they want a feedback of our results. All the potential participants will be informed about the study at the time of their attendance in clinic. Information will be provided to patients by a specialist. After the first contact, the potential participants will be recruited by the research team, the chief investigator, and she will verify that the study information have been clearly understood and obtain the written informed consent. The recruitment material makes it absolutely clear that being part of the study will have no personal therapeutic benefits.The study will be conducted according with ethical principles of Declaration of Helsinki and data will be collected in order to adhere to the Caldicott Principles.
Declining to participate will have no interference on their care and treatment.Inclusion criteria: all patients accepted for hepatitis C treatment will be invited to participate.
Confidentiality: the research team will only hold the patient identifiable data for the duration of the project. All participants information will be kept separately from anonymised data in password encrypted electronic files and in lockable cabinet and the files will only be accessible by the research members team. The research team are aware of their responsibilities to comply with the law.
Conflict of interests: there is no conflict between research and clinical roles.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
14/LO/0688
Date of REC Opinion
12 Jun 2014
REC opinion
Further Information Favourable Opinion