Clinical trial NCT00655226: Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients
Official title: Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatitis C
Depressive Disorder, Major
Depressive Disorder
Depression
HIV Infections
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
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-04-09
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression measured by PHQ-9
timeFrame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks)
measure: Depression measured by PHQ-9
timeFrame: treatment visit 0 week
measure: Depression measured by PHQ-9
timeFrame: treatment visit 2 weeks
measure: Depression measured by PHQ-9
timeFrame: treatment visit 4 weeks
measure: Depression measured by PHQ-9
timeFrame: treatment visit 8 weeks
measure: Depression measured by PHQ-9
timeFrame: treatment visit 12 weeks
measure: Depression measured by PHQ-9
timeFrame: treatment visit 18 weeks
measure: Depression measured by PHQ-9
timeFrame: treatment visit 24 weeks
measure: Depression measured by PHQ-9
timeFrame: treatment visit 30 weeks
measure: Depression measured by PHQ-9
timeFrame: treatment visit 36 weeks
measure: Depression measured by PHQ-9
timeFrame: treatment visit 42 weeks
measure: Depression measured by PHQ-9
timeFrame: treatment visit 48 weeks
Secondary outcomes:
measure: Depressive symptoms (measured by Beck Depression Inventory-II)
timeFrame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks)
measure: Depressive symptoms (measured by Beck Depression Inventory-II)
timeFrame: treatment visits 2 weeks
measure: Depressive symptoms (measured by Beck Depression Inventory-II)
timeFrame: treatment visits 4 weeks
measure: Depressive symptoms (measured by Beck Depression Inventory-II)
timeFrame: treatment visits 8 weeks
measure: Depressive symptoms (measured by Beck Depression Inventory-II)
timeFrame: treatment visits 12 weeks
measure: Depressive symptoms (measured by Beck Depression Inventory-II)
timeFrame: treatment visits 18 weeks
measure: Depressive symptoms (measured by Beck Depression Inventory-II)
timeFrame: treatment visits 24 weeks
measure: Depressive symptoms (measured by Beck Depression Inventory-II)
timeFrame: treatment visits 30 weeks
measure: Depressive symptoms (measured by Beck Depression Inventory-II)
timeFrame: treatment visits 36 weeks
measure: Depressive symptoms (measured by Beck Depression Inventory-II)
timeFrame: treatment visits 42 weeks
measure: Depressive symptoms (measured by Beck Depression Inventory-II)
timeFrame: treatment visits 48 weeks
measure: medication adherence
timeFrame: study baseline
measure: medication adherence
timeFrame: treatment visits 0 week
measure: medication adherence
timeFrame: treatment visit 2 weeks
measure: medication adherence
timeFrame: treatment visit 4 weeks
measure: medication adherence
timeFrame: treatment visit 8 weeks
measure: medication adherence
timeFrame: treatment visit 12 weeks
measure: medication adherence
timeFrame: treatment visit 18 weeks
measure: medication adherence
timeFrame: treatment visit 24 weeks
measure: medication adherence
timeFrame: treatment visit 30 weeks
measure: medication adherence
timeFrame: treatment visit 36 weeks
measure: medication adherence
timeFrame: treatment visit 42 weeks
measure: medication adherence
timeFrame: treatment visit 48 weeks
measure: hepatitis C treatment completion
timeFrame: study baseline
measure: hepatitis C treatment completion
timeFrame: treatment visit 0 week
measure: hepatitis C treatment completion
timeFrame: treatment visit 2 weeks
measure: hepatitis C treatment completion
timeFrame: treatment visit 4 weeks
measure: hepatitis C treatment completion
timeFrame: treatment visit 8 weeks
measure: hepatitis C treatment completion
timeFrame: treatment visit 12 weeks
measure: hepatitis C treatment completion
timeFrame: treatment visit 18 weeks
measure: hepatitis C treatment completion
timeFrame: treatment visit 24 weeks
measure: hepatitis C treatment completion
timeFrame: treatment visit 30 weeks
measure: hepatitis C treatment completion
timeFrame: treatment visit 36 weeks
measure: hepatitis C treatment completion
timeFrame: treatment visit 42 weeks
measure: hepatitis C treatment completion
timeFrame: treatment visit 48 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Thomas G McGinn, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: