Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients
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ClinicalTrials.gov Identifier: NCT00655226 |
Recruitment Status
:
Terminated
(low enrollment)
First Posted
: April 9, 2008
Last Update Posted
: August 9, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C Depressive Disorder, Major Depressive Disorder Depression HIV Infections | Behavioral: Hepatitis C educational support groups Behavioral: Cognitive Behavioral Therapy skills based group sessions | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: CBT skills based group sessions
Cognitive Behavioral Therapy skills based group sessions
|
Behavioral: 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.
|
Active Comparator: Hepatitis C educational support groups
Hepatitis C educational support groups
|
Behavioral: Hepatitis C educational support groups
Hepatitis C educational support groups
|
- 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 ]

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- >21 years
- Speak and read English to 5th grade level of higher.
- Eligible and ready to begin Peg-Interferon and Ribavirin (PEG-IFN/RBV) therapy for HCV at Mount Sinai's Primary Care practice or JMFC
- HIV infected patients will need to have a CD4 count > 100 and have demonstrated compliance to retroviral therapy
- Not majorly depressed upon entry to study.
- Signed informed consent to participate in CBT study
Exclusion Criteria:
- Majorly depressed (based on administration of the PHQ-9, score considered for Major Depressive Disorder).
- Admit to actively abusing illicit drugs or alcohol
- Medical contraindications to a standard course of interferon/ribavirin therapy (eg: severe anemia, uncontrolled congestive heart failure)
- Less than one year of life expectancy
- Current participation in CBT related psychotherapy
- Participation in any psychotherapy beginning less than 6 months before CBT sessions begin.
- Initiated anti-depressant medication less than 6 months before CBT sessions begin
- Severe comorbid psychiatric disease including bipolar disorder, severe personality disorder, or psychotic disorder
- Active suicidal ideation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655226
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 |
Principal Investigator: | Thomas G McGinn, MD, MPH | Icahn School of Medicine at Mount Sinai |
Responsible Party: | Thomas McGinn, MD, MPH, Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00655226 History of Changes |
Other Study ID Numbers: |
GCO# 05-0961 R21DA021531 ( U.S. NIH Grant/Contract ) |
First Posted: | April 9, 2008 Key Record Dates |
Last Update Posted: | August 9, 2011 |
Last Verified: | August 2011 |
Keywords provided by Icahn School of Medicine at Mount Sinai:
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 |
Additional relevant MeSH terms:
Disease Depression Depressive Disorder Hepatitis Hepatitis C HIV Infections Substance-Related Disorders Depressive Disorder, Major Pathologic Processes Behavioral Symptoms Mood Disorders Mental Disorders Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Flaviviridae Infections RNA Virus Infections Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Chemically-Induced Disorders Interferons Ribavirin Interferon-alpha Antineoplastic Agents Antiviral Agents |