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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00655226
• Other study ID #: GCO# 05-0961
• Secondary ID: R21DA021531
• Status: Terminated
• Phase: N/A
• First received: April 3, 2008
• Last updated: August 5, 2011
• Start date: March 2008
• Est. completion date: May 2010

Study information

• Verified date: August 2011
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Hepatitis C
• HIV Infections

Intervention

Behavioral:
• Hepatitis C educational support groups
Hepatitis C educational support groups
• Cognitive 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.

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression measured by PHQ-9		study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks)	No
Primary	Depression measured by PHQ-9		treatment visit 0 week	No
Primary	Depression measured by PHQ-9		treatment visit 2 weeks	No
Primary	Depression measured by PHQ-9		treatment visit 4 weeks	No
Primary	Depression measured by PHQ-9		treatment visit 8 weeks	No
Primary	Depression measured by PHQ-9		treatment visit 12 weeks	No
Primary	Depression measured by PHQ-9		treatment visit 18 weeks	No
Primary	Depression measured by PHQ-9		treatment visit 24 weeks	No
Primary	Depression measured by PHQ-9		treatment visit 30 weeks	No
Primary	Depression measured by PHQ-9		treatment visit 36 weeks	No
Primary	Depression measured by PHQ-9		treatment visit 42 weeks	No
Primary	Depression measured by PHQ-9		treatment visit 48 weeks	No
Secondary	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)	No
Secondary	Depressive symptoms (measured by Beck Depression Inventory-II)		treatment visits 2 weeks	No
Secondary	Depressive symptoms (measured by Beck Depression Inventory-II)		treatment visits 4 weeks	No
Secondary	Depressive symptoms (measured by Beck Depression Inventory-II)		treatment visits 8 weeks	No
Secondary	Depressive symptoms (measured by Beck Depression Inventory-II)		treatment visits 12 weeks	No
Secondary	Depressive symptoms (measured by Beck Depression Inventory-II)		treatment visits 18 weeks	No
Secondary	Depressive symptoms (measured by Beck Depression Inventory-II)		treatment visits 24 weeks	No
Secondary	Depressive symptoms (measured by Beck Depression Inventory-II)		treatment visits 30 weeks	No
Secondary	Depressive symptoms (measured by Beck Depression Inventory-II)		treatment visits 36 weeks	No
Secondary	Depressive symptoms (measured by Beck Depression Inventory-II)		treatment visits 42 weeks	No
Secondary	Depressive symptoms (measured by Beck Depression Inventory-II)		treatment visits 48 weeks	No
Secondary	medication adherence		study baseline	No
Secondary	medication adherence		treatment visits 0 week	No
Secondary	medication adherence		treatment visit 2 weeks	No
Secondary	medication adherence		treatment visit 4 weeks	No
Secondary	medication adherence		treatment visit 8 weeks	No
Secondary	medication adherence		treatment visit 12 weeks	No
Secondary	medication adherence		treatment visit 18 weeks	No
Secondary	medication adherence		treatment visit 24 weeks	No
Secondary	medication adherence		treatment visit 30 weeks	No
Secondary	medication adherence		treatment visit 36 weeks	No
Secondary	medication adherence		treatment visit 42 weeks	No
Secondary	medication adherence		treatment visit 48 weeks	No
Secondary	hepatitis C treatment completion		study baseline	No
Secondary	hepatitis C treatment completion		treatment visit 0 week	No
Secondary	hepatitis C treatment completion		treatment visit 2 weeks	No
Secondary	hepatitis C treatment completion		treatment visit 4 weeks	No
Secondary	hepatitis C treatment completion		treatment visit 8 weeks	No
Secondary	hepatitis C treatment completion		treatment visit 12 weeks	No
Secondary	hepatitis C treatment completion		treatment visit 18 weeks	No
Secondary	hepatitis C treatment completion		treatment visit 24 weeks	No
Secondary	hepatitis C treatment completion		treatment visit 30 weeks	No
Secondary	hepatitis C treatment completion		treatment visit 36 weeks	No
Secondary	hepatitis C treatment completion		treatment visit 42 weeks	No
Secondary	hepatitis C treatment completion		treatment visit 48 weeks	No