Value of clinical psychologist's role in minimizing psychological distress in hepatitis C treatment

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Hepatitis C (HCV) is a blood borne virus which primarily infects and damages the liver. About 75-80% of people who acquired the acute hepatitis C will develop a chronic infection. Out of those about 20% will develop severe liver disease (cirrhosis) in 20-40 years following the acquisition of the disease. About 5% will develop liver failure and liver cancer. It is estimated there were around 264,000 people living with HCV antibodies in Australia in 2005 (range 206,000 to 318,000). 197,000 were estimated to be living with chronic HCV infection (range 154,000 to 238,000). The current treatment for chronic hepatitis C is pegylated interferon and Ribavirin. Interferons are chemicals produced by cells in response to viral infection. Ribavirin is an anti viral medication. The treatment duration is either 6 or 12 months. The treatment results in 50-80% success in eradicating the virus depending on the viral load and subtype of the virus. The success also depends on the total amount of medications taken by the patient. Less than 80% of the medications taken less than 80% of the time will result in significant decrease in the success rate. The Interferons cause psychological side effects including depression, anxiety, anger, mania and psychosis. It is estimated about 30-40% patients will feel one or more of the above symptoms during the course of the therapy with about 20% meeting criteria for major depression. These symptoms significantly reduce the quality of life of the patients who undergo therapy. In addition these can lead to reduction in medication dose, non compliance and premature therapy termination resulting in reduction in success of eradication the virus. Gastroenterologists working in this setting are very aware of the psychiatric adverse effects, routinely inquire about them and at times treat depression and other disorders they may find, and/or refer the patients for psychiatric care. They provide patients with information booklets covering this and other topics to do with interferon therapy. Some patients are symptomatic and are referred for psychiatric care right at the start, before interferon is commenced. The majority, however, are commenced on interferon and referred if and when psychiatric problems emerge. The capacity for gastroenterologists to comprehensively deal with these problems is necessarily limited and, in addition, it is preferable to recognize emerging symptoms and to commence therapy early to minimize the impact of these side effects on overall outcome. Availability of psychiatrists and psychologists is very limited, so the usual practice in hepatitis C treatment centers is to refer patients for psychiatric care if and when problems arise. We propose to conduct a pilot randomized trial to explore the value of early contact with a psychologist in reducing the risk of psychiatric side effects and improving access to psychological and psychiatric care when needed. Study participants will be recruited from the hepatitis C clinics at St Vincent’s Hospital (Melbourne) and will exclude those referred to the psychiatrist at baseline. All other patients will be randomly assigned to two groups at the beginning of interferon therapy. The first group will be offered what we have termed a ‘psychological care gateway’ consisting of two appointments with a psychologist, plus two offers: (i) further appointments with the psychologist as needed and (ii) access to a weekly supportive group on ‘coping with interferon therapy’, all this in addition to ‘treatment as usual’, i.e. attendances at the HCV clinic to see their gastroenterologist and the clinic nurse. The second group will receive ‘treatment as usual’. During the interferon therapy, both the psychologist and gastroenterologists will continue to refer patients to the psychiatrist as usual if the clinical need arises. The main outcome measure will be reduction in psychiatric symptom levels, measured by questionnaire. Secondary outcomes will be the interferon therapy discontinuation rate, rates of clinically diagnosed psychiatric disorder, and quality of life. In addition, we will measure the uptake of the ‘psychological care gateway’, and the extent to which its components are acceptable to and utilized by patients. Psychometric tests will be used to define which patients will benefit from the early psychiatric review. This pilot study is expected to recruit about 48 participants within 24 weeks for randomization and to be completed in 72 weeks. Data gathered in the pilot will guide the design of future trials of provision of psychological care for these patients.

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