Hepatitis CNCT00655226

Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients

A study testing Hepatitis C educational support groups and Cognitive Behavioral Therapy skills based group sessions in people with Hepatitis C and Depressive Disorder, Major, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective in the prevention of depression during interferon and ribavirin treatment for hepatitis C infection. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Hepatitis C, Depressive Disorder, Major, Depressive Disorder
What is being tested?: Hepatitis C educational support groups and Cognitive Behavioral Therapy skills based group sessions
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Mar 2008to May 2010
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

>21 years
Speak and read English to 5th grade level of higher.
Eligible and ready to begin Peg-Interferon and Ribavirin (PEG-IFN/RBV) therapy for HCV at Mount Sinai's Primary Care practice or JMFC
HIV infected patients will need to have a CD4 count > 100 and have demonstrated compliance to retroviral therapy
Not majorly depressed upon entry to study.
Signed informed consent to participate in CBT study

Who cannot join

Majorly depressed (based on administration of the PHQ-9, score considered for Major Depressive Disorder).
Admit to actively abusing illicit drugs or alcohol
Medical contraindications to a standard course of interferon/ribavirin therapy (eg: severe anemia, uncontrolled congestive heart failure)
Less than one year of life expectancy
Current participation in CBT related psychotherapy
Participation in any psychotherapy beginning less than 6 months before CBT sessions begin.

Show all 9Show fewer

Initiated anti-depressant medication less than 6 months before CBT sessions begin
Severe comorbid psychiatric disease including bipolar disorder, severe personality disorder, or psychotic disorder
Active suicidal ideation

Trial locations and contacts

1 site in 1 country.

United States1 site

Mount Sinai School of Medicine
New York, New York, 10029

Other trials in United States

About this study

The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective in the prevention of depression during interferon and ribavirin treatment for hepatitis C infection.

Read the detailed description

The treatment for active hepatitis C in both HCV mono-infected and HCV/HIV co-infected patients is a long and difficult course, involving combination therapy of interferon and ribavirin for 6 to 12 months, a therapy with significant side effects. Up to 40% of patients being treated will develop depression due to the medication, which in turn leads to discontinuation of therapy and lost opportunities to prevent end stage liver disease. In fact, the presence of depression prior to interferon treatment often excludes patients from receiving interferon therapy, thereby denying them a potentially life-saving treatment. Non-pharmacological therapies such as cognitive behavioral therapy (CBT) have demonstrated efficacy in treating primary depression in numerous studies including in patients under going treatment with chronic medical illness. CBT is a well-established treatment modality and has been shown in several large randomized trials to be as effective, and in some cases more effective, than antidepressants. CBT has also shown efficacy in preventing the development of depression and other emotional disorders in high-risk populations. Offering CBT prior to and during treatment with interferon to non-depressed patients is a unique method that may reduce rates of depression and increase adherence to treatment without exposing patients to the risk of an additional medication.

Conditions: Hepatitis C, Depressive Disorder, Major, Depressive Disorder, Depression, HIV Infections
Being tested: Hepatitis C educational support groups, Cognitive Behavioral Therapy skills based group sessions
Keywords: Cognitive Behavior Therapy, Interferon-alpha, Communicable Diseases, Liver Diseases, Depression, Hepatitis, Chronic, Interferons, Ribavirin, Hepatitis, Viral, Human, Infection, Hepatitis, Mood Disorders, Peginterferon alfa-2a, Hepatitis C, Interferon Alfa-2a, Interferon Alfa-2b, Depressive Disorder, Major, Depressive Disorder
Medical subject headings: Hepatitis C, Depressive Disorder, Major, Depressive Disorder, Depression, HIV Infections, Communicable Diseases, Liver Diseases, Hepatitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hepatitis C educational support groupsBehavioural
Hepatitis C educational support groups
Cognitive Behavioral Therapy skills based group sessionsBehavioural
Eight CBT group sessions tailored for hepatitis C patients conducted by a clinical psychologist: 3 sessions conducted prior to IFN/ribavirin initiation, 1 session the day of IFN/ribavirin initiation, and 4 sessions during IFN/ribavirin treatment.

Study groups in NCT00655226
Study group	Role	What they receive
CBT skills based group sessions	Experimental	Cognitive Behavioral Therapy skills based group sessions Receives: Behavioral: Cognitive Behavioral Therapy skills based group sessions
Hepatitis C educational support groups	Active comparator	Hepatitis C educational support groups Receives: Behavioral: Hepatitis C educational support groups

What is being measured

The primary outcome is the main question the study is designed to answer.

Depression measured by PHQ-9
Measured: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks)
Depression measured by PHQ-9
Measured: treatment visit 0 week
Depression measured by PHQ-9
Measured: treatment visit 2 weeks
Depression measured by PHQ-9
Measured: treatment visit 4 weeks
Depression measured by PHQ-9
Measured: treatment visit 8 weeks
Depression measured by PHQ-9
Measured: treatment visit 12 weeks
Depression measured by PHQ-9
Measured: treatment visit 18 weeks
Depression measured by PHQ-9
Measured: treatment visit 24 weeks
Depression measured by PHQ-9
Measured: treatment visit 30 weeks
Depression measured by PHQ-9
Measured: treatment visit 36 weeks
Depression measured by PHQ-9
Measured: treatment visit 42 weeks
Depression measured by PHQ-9
Measured: treatment visit 48 weeks

Secondary outcomes (35)

Depressive symptoms (measured by Beck Depression Inventory-II)
Measured: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks)
Depressive symptoms (measured by Beck Depression Inventory-II)
Measured: treatment visits 2 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Measured: treatment visits 4 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Measured: treatment visits 8 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Measured: treatment visits 12 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Measured: treatment visits 18 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Measured: treatment visits 24 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Measured: treatment visits 30 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Measured: treatment visits 36 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Measured: treatment visits 42 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Measured: treatment visits 48 weeks
medication adherence
Measured: study baseline
medication adherence
Measured: treatment visits 0 week
medication adherence
Measured: treatment visit 2 weeks
medication adherence
Measured: treatment visit 4 weeks
medication adherence
Measured: treatment visit 8 weeks
medication adherence
Measured: treatment visit 12 weeks
medication adherence
Measured: treatment visit 18 weeks
medication adherence
Measured: treatment visit 24 weeks
medication adherence
Measured: treatment visit 30 weeks
medication adherence
Measured: treatment visit 36 weeks
medication adherence
Measured: treatment visit 42 weeks
medication adherence
Measured: treatment visit 48 weeks
hepatitis C treatment completion
Measured: study baseline
hepatitis C treatment completion
Measured: treatment visit 0 week
hepatitis C treatment completion
Measured: treatment visit 2 weeks
hepatitis C treatment completion
Measured: treatment visit 4 weeks
hepatitis C treatment completion
Measured: treatment visit 8 weeks
hepatitis C treatment completion
Measured: treatment visit 12 weeks
hepatitis C treatment completion
Measured: treatment visit 18 weeks
hepatitis C treatment completion
Measured: treatment visit 24 weeks
hepatitis C treatment completion
Measured: treatment visit 30 weeks
hepatitis C treatment completion
Measured: treatment visit 36 weeks
hepatitis C treatment completion
Measured: treatment visit 42 weeks
hepatitis C treatment completion
Measured: treatment visit 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008May 2010

First posted9 Apr 2008 (estimated)
Study startMar 2008
Primary completionMay 2010
Study completionMay 2010

Why it stopped: low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00655226
Sponsor's protocol ID: GCO# 05-0961
Other IDs: R21DA021531
Status last verified: Aug 2011
First submitted: 3 Apr 2008
Last updated: 9 Aug 2011
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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