Depression, Depressive Disorder, Depressive Disorder, Major, Hepatitis C, HIV Infections
Conditions
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
Brief 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.
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.
Interventions
BEHAVIORALHepatitis C educational support groups
Hepatitis C educational support groups
BEHAVIORALCognitive Behavioral Therapy skills based group sessions
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.
Sponsors
National Institute on Drug Abuse (NIDA)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>21 years 2. Speak and read English to 5th grade level of higher. 3. Eligible and ready to begin Peg-Interferon and Ribavirin (PEG-IFN/RBV) therapy for HCV at Mount Sinai's Primary Care practice or JMFC 4. HIV infected patients will need to have a CD4 count \> 100 and have demonstrated compliance to retroviral therapy 5. Not majorly depressed upon entry to study. 6. Signed informed consent to participate in CBT study
Exclusion criteria
1. Majorly depressed (based on administration of the PHQ-9, score considered for Major Depressive Disorder). 2. Admit to actively abusing illicit drugs or alcohol 3. Medical contraindications to a standard course of interferon/ribavirin therapy (eg: severe anemia, uncontrolled congestive heart failure) 4. Less than one year of life expectancy 5. Current participation in CBT related psychotherapy 6. Participation in any psychotherapy beginning less than 6 months before CBT sessions begin. 7. Initiated anti-depressant medication less than 6 months before CBT sessions begin 8. Severe comorbid psychiatric disease including bipolar disorder, severe personality disorder, or psychotic disorder 9. Active suicidal ideation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression measured by PHQ-9 | study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Depressive symptoms (measured by Beck Depression Inventory-II) | study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) |
| medication adherence | study baseline |
| hepatitis C treatment completion | study baseline |
Countries
United States
Outcome results
None listed