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

NCT00655226 | Terminated DMC

• 2 other identifiers: GCO# 05-0961R21DA021531
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• Depression measured by PHQ-9

  study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks)

• Depression measured by PHQ-9

  treatment visit 0 week

• Depression measured by PHQ-9

  treatment visit 2 weeks

• Depression measured by PHQ-9

  treatment visit 4 weeks

• Depression measured by PHQ-9

  treatment visit 8 weeks

• Depression measured by PHQ-9

  treatment visit 12 weeks

• Depression measured by PHQ-9

  treatment visit 18 weeks

• Depression measured by PHQ-9

  treatment visit 24 weeks

• Depression measured by PHQ-9

  treatment visit 30 weeks

• Depression measured by PHQ-9

  treatment visit 36 weeks

• Depression measured by PHQ-9

  treatment visit 42 weeks

• Depression measured by PHQ-9

  treatment visit 48 weeks

Secondary Outcomes (35)

• 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)

• Depressive symptoms (measured by Beck Depression Inventory-II)

  treatment visits 2 weeks

• Depressive symptoms (measured by Beck Depression Inventory-II)

  treatment visits 4 weeks

• Depressive symptoms (measured by Beck Depression Inventory-II)

  treatment visits 8 weeks

• Depressive symptoms (measured by Beck Depression Inventory-II)

  treatment visits 12 weeks

Study Arms (2)

CBT skills based group sessions

EXPERIMENTAL

Cognitive Behavioral Therapy skills based group sessions

Behavioral: Cognitive Behavioral Therapy skills based group sessions

Hepatitis C educational support groups

ACTIVE COMPARATOR

Hepatitis C educational support groups

Behavioral: Hepatitis C educational support groups

Interventions

Hepatitis C educational support groups BEHAVIORAL

Hepatitis C educational support groups

Hepatitis C educational support groups

Cognitive Behavioral Therapy skills based group sessions BEHAVIORAL

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.

CBT skills based group sessions

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Hepatitis C; Depressive Disorder, Major; Depressive Disorder; Depression; HIV Infections; Communicable Diseases; Liver Diseases; Hepatitis, Chronic; Hepatitis, Viral, Human; Infections; Hepatitis; Mood Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Digestive System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chronic Disease

Study Officials

• Thomas G McGinn, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 9, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 9, 2011

Record last verified: 2011-08

Locations

US (1)