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Trial registered on ANZCTR


Registration number
ACTRN12608000377336
Ethics application status
Approved
Date submitted
23/07/2008
Date registered
1/08/2008
Date last updated
1/08/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Value of clinical psychologist's role in minimizing psychological distress in hepatitis C treatment
Scientific title
Significance of Psychological care in reducing psychiatric comorbidity during interferon therapy in Hepatitis C
Secondary ID [1] 656 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hepatitis C 3454 0
Psychiatric conditions 3455 0
Condition category
Condition code
Infection 3613 3613 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psychoeducation - Participants in the active arm will receive 2, one hour sessions with a clinical psychologist, first 0-2 weeks before and second session 2 weeks after starting the interferon/ribavirin therapy. Sessions will focus on participants’ current psychological state, common psychiatric side effects and copings strategies and developing an individual management plan. At the end of two sessions they will be invited (optional) to attend an open group sessions or to see the psychologist individually for the duration of their treatment (24 weeks for genotype 2, 3 and 48 weeks for genotype 1)

This intervention is in additional to the standard care given to them at Hepatitis C treatment clinic.
Intervention code [1] 3182 0
Prevention
Comparator / control treatment
No Psychoeducation but standard therapy.
Standard therapy is care participants receive from their treating physician and hepatitis C nurse at the regular hepatitis C treatment clinic appointments. These appointment will be at 0, 2, 4 weeks from the time of 1st dose of medicine and then every 4th week after the 4 th week.
Control group
Active

Outcomes
Primary outcome [1] 4506 0
reducation in psychological distress measured by K10( The Kessler Psychological Distress Scale) score (by 5 points)
Timepoint [1] 4506 0
At 12 weeks after the 1st dose of Interferon and ribavirin
Secondary outcome [1] 7624 0
reduction in psychaitric conditions diagnosed clinically by a psychaitrist.
Timepoint [1] 7624 0
At completion of interferon therapy which is 24 weeks for genotype 2,3 and 48 weeks for genotype 1
Secondary outcome [2] 7625 0
Virological response at the end of therapy by Polymerase chain reaction (PCR)
Timepoint [2] 7625 0
Week 24 for genotype 2 or 3 and week 48 for genotype 1
Secondary outcome [3] 7626 0
use of psychotrophic drugs
Timepoint [3] 7626 0
during the interferon therapy (week 24 for genotype 2,3 and week 48 for genotype 1)

Eligibility
Key inclusion criteria
Age 18-70
Presence of Hepatitis C (on polymerase chain reaction) and eligible for pegylated interferon and ribavirn therapy
able to understand study protocol and consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current active psychiactric condition dignosed by a medical practitioner.
Pateints who are in regular care with a psychiatrist or a psychologist.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization is done by block randomization.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3669 0
Self funded/Unfunded
Name [1] 3669 0
Country [1] 3669 0
Australia
Primary sponsor type
Individual
Name
N J Arachchi
Address
Department of Gastroenterology
St Vincent's Hospital
PO box 2900 Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 3269 0
None
Name [1] 3269 0
Address [1] 3269 0
Country [1] 3269 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5723 0
Human research ethic committee - A (St Vincent's Hospital)
Ethics committee address [1] 5723 0
Research and Grants Unit
St Vincent's Hospital(Melbourne)
PO Box 2900, Fitzroy VIC 3065
Ethics committee country [1] 5723 0
Australia
Date submitted for ethics approval [1] 5723 0
Approval date [1] 5723 0
16/07/2008
Ethics approval number [1] 5723 0
HREC-A 022/08

Summary
Brief summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28776 0
Address 28776 0
Country 28776 0
Phone 28776 0
Fax 28776 0
Email 28776 0
Contact person for public queries
Name 11933 0
Dr. NJ Arachchi
Address 11933 0
Department of Gastroenterology, St Vincent's hospital, PO Box 2900, Fitzroy VIC 3065
Country 11933 0
Australia
Phone 11933 0
0392883580
Fax 11933 0
Email 11933 0
[email protected]
Contact person for scientific queries
Name 2861 0
Dr. NJ Arachchi
Address 2861 0
Department of Gastroenterology, St Vincent's hospital, PO Box 2900, Fitzroy VIC 3065
Country 2861 0
Australia
Phone 2861 0
0392883580
Fax 2861 0
Email 2861 0
[email protected]

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