An interventional study of Hepatitis C educational support groups and Cognitive Behavioral Therapy skills based group sessions in Hepatitis C, Depressive Disorder, Major and Depressive Disorder, sponsored by Icahn School of Medicine at Mount Sinai. Terminated at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2011-08-09.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
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.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 26 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cognitive Behavioral Therapy skills based group sessions
Behavioral: Cognitive Behavioral Therapy skills based group sessions
Hepatitis C educational support groups
Behavioral: Hepatitis C educational support groups
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.
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
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
This study is terminated, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai