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Clinical Trials

MainTitle

IMPAACT 2002: Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression Among US Youth With HIV

This study has been enrolling by invitation
Sponsor
International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)

Information provided by (Responsible Party)
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier
NCT02939131

First received: October 7, 2016
Last updated: July 14, 2017
Last Verified: July 2017
History of Changes
Purpose

Purpose

IMPAACT 2002 is a prospective, multi-site, two-arm, cluster-randomized study to evaluate whether a health and wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention for depression demonstrates improved depression and medical outcomes for HIV-infected youth in the US compared to enhanced standard care (ESC).

Condition Intervention
HIV
Depression

Behavioral : Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm
Behavioral : Enhanced Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IMPAACT 2002: Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression Among Youth Living With HIV in the United States

Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Primary Outcome Measures

  • Depression Outcomes: Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR) Score [ Time Frame: Week 24 ]
  • Depression Outcomes: Response to Treatment, defined as a decrease in QIDS-SR score by >50% [ Time Frame: Week 24 ]
    2) Plasma HIV RNA level
  • Depression Outcomes: Remission, defined as a QIDS-SR Score <= 5 [ Time Frame: Week 24 ]
  • Biological Outcomes: CD4 cell count [ Time Frame: Week 24 ]
  • Biological Outcomes: Plasma HIV RNA Level [ Time Frame: Week 24 ]
Secondary Outcome Measures:
  • Adherence Outcomes: Adherence to anti-HIV Medications [ Time Frame: Over 24 and 48 Weeks ]
    Adherence to anti-HIV medications at each assessment for the first 24 weeks (during active treatment) and at 48 weeks, as measured by self-report
  • Adherence Outcomes: Adherence to Psychiatric Medications [ Time Frame: Over 24 and 48 Weeks ]
    Adherence to psychiatric medications at each assessment for the first 24 weeks (during active treatment) and at 48 weeks, as measured by self-report
  • Adherence Outcomes: Adherence to Study Visits and Psychotherapy Sessions [ Time Frame: Over 24 and 48 Weeks ]
  • Depression Outcomes: QIDS-SR Score over 48 Weeks [ Time Frame: Over 48 Weeks ]
    QIDS-SR score (defined above) over 48 weeks
  • Depression Outcomes: Response to Treatment over 48 Weeks [ Time Frame: Over 48 Weeks ]
    Response to treatment (defined above) over 48 weeks
  • Depression Outcomes: Remission over 48 Weeks [ Time Frame: Over 48 Weeks ]
    Remission (defined above) over 48 weeks
  • Effect of Demographic, Behavioral, and Biological Modifiers on Depression Outcomes: QIDS-SR Score (defined above) [ Time Frame: Over 48 Weeks ]
    Effect of moderators (Demographic: age, gender. Behavioral: HIV acquisition category, initial level of depression; Biological: baseline CD4, nadir CD4, plasma HIV RNA, CDC category) on depression outcomes: QIDS-SR Score
  • Effect of Demographic, Behavioral, and Biological Modifiers on Depression Outcomes: Response to Treatment (defined above) [ Time Frame: Over 48 Weeks ]
    Effect of moderators (Demographic: age, gender. Behavioral: HIV acquisition category, initial level of depression; Biological: baseline CD4, nadir CD4, plasma HIV RNA, CDC category) on depression outcomes: Response to Treatment
  • Effect of Demographic, Behavioral, and Biological Modifiers on Depression Outcomes: Remission (defined above) [ Time Frame: Over 48 Weeks ]
    Effect of moderators (Demographic: age, gender. Behavioral: HIV acquisition category, initial level of depression; Biological: baseline CD4, nadir CD4, plasma HIV RNA, CDC category) on depression outcomes: Remission
  • Behavioral Risk Outcomes: Alcohol/Drug Use [ Time Frame: Weeks 24 and 48 ]
  • Behavioral Risk Outcomes: Sex-Risk Behaviors [ Time Frame: Weeks 24 and 48 ]
  • Implementation Fidelity (COMB-R sites); Counseling Strategies (ESC sites) [ Time Frame: 24 Weeks ]
  • Patterns of Psychiatric Medication Use [ Time Frame: 24 and 48 Weeks ]
  • Number of Interim Counseling Visits [ Time Frame: 24 and 48 Weeks ]
  • Frequency of Psychiatric Medication Use [ Time Frame: 24 and 48 Weeks ]
  • COMB-R and ESC Acceptability among Participants and Clinicians [ Time Frame: 24 Weeks ]
  • Grade 3 or Higher Adverse Events, Psychological Hospitalizations, and Suicide Attempts [ Time Frame: Over 48 Weeks ]

Estimated Enrollment: 156
Study Start Date: March 6, 2017
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: COMB-R
Health and Wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention
Behavioral: Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm

Behavioral therapy based on a manualized approach developed specifically for youth living with both HIV and depression, using problem-solving, motivational interviewing and cognitive-behavioral strategies to decrease adherence obstacles and increase wellness. The medication management algorithm includes guidance for clinicians on strategies and tactics to treat depression in this population, including factors to consider when deciding on treatments (i.e., drug-drug interactions, side effects).

Active Comparator: ESC
Enhanced Standard of Care (ESC)
Behavioral: Enhanced Standard of Care

Ongoing psychopharmacological and psychosocial counseling and treatment for depression at HIV clinical treatment centers enhanced by providing clinicians with up-to-date information and didactic training on current principles for use of medication and psychotherapy in the treatment of depression.

Detailed Description:

IMPAACT 2002 is a prospective, multi-site, two-arm, cluster-randomized study to evaluate whether a health and wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention for depression demonstrates improved depression outcomes (e.g., decreased depressive symptoms and greater remission and response rates) and medical outcomes (e.g., increased CD4 T-cell count, decreased HIV RNA level) among HIV-infected youth in the US compared to enhanced standard care (ESC). Youth enrolled in the study will attend a Screening/Entry Visit and study visits at Weeks 1, 6, 12, and 24. They will have two additional follow-up visits at Weeks 36 and 48 for the study team to evaluate if observed effects of the intervention are maintained. The intervention is a treatment for depression that includes manualized Health and Wellness Cognitive Behavioral Therapy and algorithm-driven Medication Management designed to address the unique challenges faced by this population.

Eligibility

Eligibility

Ages Eligible for Study: 12 Years to 24 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Receiving mental health or HIV-related care at participating US IMPAACT site
  • Confirmed of HIV-1 Infection
  • Aware of his or her HIV infection
  • Per clinician assessment, primary diagnosis of nonpsychotic depression, including Major Depressive Disorder, Depression NOS, or Dysthymia, as defined by DSM-IV or DSM-V criteria
  • Current depressive symptoms that warrant intervention as determined by a score of ≥ 11 on the Quick Inventory of Depressive Symptomatology - Clinician (QIDS-C)
  • Able to communicate in spoken and written English
  • Able and willing to provide written informed assent/consent and able to obtain written parental or guardian permission (if required, as specified in site SOP, by State law, and/or IRB policy) to be screened for and to enroll in IMPAACT 2002


Exclusion Criteria:
  • Known or self-reported history of any psychotic disorder and/or bipolar I or II disorder
  • Severe disorders (more than 6 symptoms) based on DSM-V criteria) related to alcohol, cannabis or other substances; or those with moderate symptoms (4 or 5 symptoms) who are also currently experiencing withdrawal or dependence symptoms; within the past month prior to enrollment
  • Per clinician assessment at screening, depression and/or suicidal ideation requiring more intensive treatment than the study provides or at immediate risk of being a danger to themselves or others
  • Per participant report at screening, intends to relocate away from the study site during study participation
  • Currently in therapy with a non-study provider, unless willing to switch to a study-trained provider
  • Has any other condition that, in the opinion of the Investigator of Record
(IoR)/designee, would preclude informed assent/consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02939131

Locations

United States, California
University of Southern California - MCA Center (CRS 5048),
Alhambra, California, United States, 91803
University California, San Diego (CRS 4601)
La Jolla, California, United States, 92093
David Geffen School of Medicine at UCLA (CRS 5112)
Los Angeles, California, United States, 90095
United States, Colorado
Children's Hospital of Colorado (CRS 5052)
Aurora, Colorado, United States, 80045
United States, Florida
Children's Diagnostic and Treatment Center (CRS 5055)
Fort Lauderdale, Florida, United States, 33316
United States, Georgia
Emory University School of Medicine (CRS 5030)
Atlanta, Georgia, United States, 30308
United States, Illinois
Chicago Children's Hospital (CRS 4001)
Chicago, Illinois, United States, 60611
Rush University Medical Center (CRS 5083)
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins University School of Medicine (CRS 5092)
Baltimore, Maryland, United States, 21287
United States, New York
Stony Brook University Medical Center (CRS 5040)
Stony Brook, New York, United States, 11794
Bronx-Lebanon Hospital Center (CRS 5114)
The Bronx, New York, United States, 10457
Jacobi Medical Center (CRS 5013)
The Bronx, New York, United States, 10461
United States, Tennessee
St Jude Children's Research Hospital (CRS 6501)
Memphis, Tennessee, United States, 38105
United States, Texas
Texas Children's/Baylor (CRS 3801)
Houston, Texas, United States, 77030

Sponsors and Collaborators

International Maternal Pediatric Adolescent AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)

Investigators

Study Chair: Larry Brown, MD Brown University
More Information

More Information


Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group  
ClinicalTrials.gov Identifier: NCT02939131   History of Changes  
Other Study ID Numbers: IMPAACT 2002  
Study First Received: October 7, 2016  
Last Updated: July 14, 2017  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Cognitive Behavioral Therapy
Medication Management

Additional relevant MeSH terms:
Depression
Depressive Disorder

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.