ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

hepatitis C

Psychiatric conditions

Condition category

Condition code

Infection

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]

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]

reducation in psychological distress measured by K10( The Kessler Psychological Distress Scale) score (by 5 points)

Timepoint [1]

At 12 weeks after the 1st dose of Interferon and ribavirin

Secondary outcome [1]

reduction in psychaitric conditions diagnosed clinically by a psychaitrist.

Timepoint [1]

At completion of interferon therapy which is 24 weeks for genotype 2,3 and 48 weeks for genotype 1

Secondary outcome [2]

Virological response at the end of therapy by Polymerase chain reaction (PCR)

Timepoint [2]

Week 24 for genotype 2 or 3 and week 48 for genotype 1

Secondary outcome [3]

use of psychotrophic drugs

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human research ethic committee - A (St Vincent's Hospital)

Ethics committee address [1]

Research and Grants Unit
St Vincent's Hospital(Melbourne)
PO Box 2900, Fitzroy VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

16/07/2008

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. NJ Arachchi

Address

Department of Gastroenterology, St Vincent's hospital, PO Box 2900, Fitzroy VIC 3065

Country

Australia

Phone

0392883580

Fax

niranjan.arachchi@svhm.org.au

Contact person for scientific queries

Name

Dr. NJ Arachchi

Address

Department of Gastroenterology, St Vincent's hospital, PO Box 2900, Fitzroy VIC 3065

Country

Australia

Phone

0392883580

Fax

niranjan.arachchi@svhm.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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