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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Hepatitis C educational support groups
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.
Mount Sinai School of Medicine
New York, New York, United States
Depression measured by PHQ-9
Time frame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks)
Depression measured by PHQ-9
Time frame: treatment visit 0 week
Depression measured by PHQ-9
Time frame: treatment visit 2 weeks
Depression measured by PHQ-9
Time frame: treatment visit 4 weeks
Depression measured by PHQ-9
Time frame: treatment visit 8 weeks
Depression measured by PHQ-9
Time frame: treatment visit 12 weeks
Depression measured by PHQ-9
Time frame: treatment visit 18 weeks
Depression measured by PHQ-9
Time frame: treatment visit 24 weeks
Depression measured by PHQ-9
Time frame: treatment visit 30 weeks
Depression measured by PHQ-9
Time frame: treatment visit 36 weeks
Depression measured by PHQ-9
Time frame: treatment visit 42 weeks
Depression measured by PHQ-9
Time frame: treatment visit 48 weeks
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Depressive symptoms (measured by Beck Depression Inventory-II)
Time frame: 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)
Time frame: treatment visits 2 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time frame: treatment visits 4 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time frame: treatment visits 8 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time frame: treatment visits 12 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time frame: treatment visits 18 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time frame: treatment visits 24 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time frame: treatment visits 30 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time frame: treatment visits 36 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time frame: treatment visits 42 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time frame: treatment visits 48 weeks
medication adherence
Time frame: study baseline
medication adherence
Time frame: treatment visits 0 week
medication adherence
Time frame: treatment visit 2 weeks
medication adherence
Time frame: treatment visit 4 weeks
medication adherence
Time frame: treatment visit 8 weeks
medication adherence
Time frame: treatment visit 12 weeks
medication adherence
Time frame: treatment visit 18 weeks
medication adherence
Time frame: treatment visit 24 weeks
medication adherence
Time frame: treatment visit 30 weeks
medication adherence
Time frame: treatment visit 36 weeks
medication adherence
Time frame: treatment visit 42 weeks
medication adherence
Time frame: treatment visit 48 weeks
hepatitis C treatment completion
Time frame: study baseline
hepatitis C treatment completion
Time frame: treatment visit 0 week
hepatitis C treatment completion
Time frame: treatment visit 2 weeks
hepatitis C treatment completion
Time frame: treatment visit 4 weeks
hepatitis C treatment completion
Time frame: treatment visit 8 weeks
hepatitis C treatment completion
Time frame: treatment visit 12 weeks
hepatitis C treatment completion
Time frame: treatment visit 18 weeks
hepatitis C treatment completion
Time frame: treatment visit 24 weeks
hepatitis C treatment completion
Time frame: treatment visit 30 weeks
hepatitis C treatment completion
Time frame: treatment visit 36 weeks
hepatitis C treatment completion
Time frame: treatment visit 42 weeks
hepatitis C treatment completion
Time frame: treatment visit 48 weeks