Clinical trial NCT02939131: IMPAACT 2002: Cognitive Behavioral Therapy and Medication Management for Treatment of Depression in US Youth With HIV
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Depression
Keywords: Cognitive Behavioral Therapy
Medication Management
Lead sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Mental Health (NIMH)
First posted: 2016-10-19
Enrollment: 156
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 United States (US) compared to enhanced standard care (ESC).

Detailed description: IMPAACT 2002 was a prospective, multi-site, two-arm, cluster-randomized study that evaluated whether a health and wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention for depression demonstrated improved depression outcomes (e.g., decreased depressive symptoms and greater remission and response rates) and medical outcomes (e.g., increased cluster of differentiation 4 (CD4) T-cell count, decreased HIV RNA level) among HIV-infected youth in the US compared to enhanced standard care (ESC). Sites were randomized to either the COMB-R intervention or the ESC control arm. Youth enrolled in the study attended a Screening/Entry Visit and study visits at Weeks 1, 6, 12, and 24. They had two additional follow-up visits at Weeks 36 and 48 for the study team to evaluate if observed effects of the intervention were maintained. The intervention was a treatment for depression that included a manualized Health and Wellness Cognitive Behavioral Therapy and an algorithm-driven Medication Management designed to address the unique challenges faced by this population.

Eligibility criteria: Inclusion Criteria:

* Receiving mental health or HIV-related care at participating US IMPAACT site
* Confirmed HIV-1 Infection
* Aware of his or her HIV infection
* Per clinician assessment, primary diagnosis of nonpsychotic depression, including Major Depressive Disorder, Depression Not Otherwise Specified (NOS), or Dysthymia, as defined by Diagnostic and Statistical Manual of Mental Disorders (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 standard operating procedure (SOP), by State law, and/or Institutional Review Board (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

Primary outcomes:
measure: Depression Outcomes: Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR) Score
timeFrame: Week 24
measure: Depression Outcomes: Response to Treatment, Defined as a Decrease in QIDS-SR Score by >50%
timeFrame: Week 0 and Week 24
measure: Depression Outcomes: Remission, Defined as a QIDS-SR Score <= 5
timeFrame: Week 24
measure: Biological Outcomes: Cluster of Differentiation 4 (CD4) Cell Count at Week 24
timeFrame: Week 24
measure: Biological Outcomes: Plasma HIV RNA Level at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Adherence Outcomes: Adherence to Anti-HIV Medications - Number of Days in Last 30 With Any Missed Doses
timeFrame: Weeks 24 and 48
measure: Adherence Outcomes: Adherence to Anti-HIV Medications - How Good Participant Was at Taking Medicines as Instructed
timeFrame: Weeks 24 and 48
measure: Adherence Outcomes: Adherence to Anti-HIV Medications - How Often Did Participant Take Medications as Instructed
timeFrame: Weeks 24 and 48
measure: Adherence Outcomes: Adherence to Psychiatric Medications - Number of Days in Last 30 With Any Missed Doses
timeFrame: Weeks 24 and 48
measure: Adherence Outcomes: Adherence to Psychiatric Medications - How Good Participant Was at Taking Medications as Instructed
timeFrame: Weeks 24 and 48
measure: Adherence Outcomes: Adherence to Psychiatric Medications - How Often Did Participant Take Medicines as Instructed
timeFrame: Weeks 24 and 48
measure: Adherence Outcomes: Adherence to Psychotherapy Sessions
timeFrame: Weeks 1, 6, 12 and 24
measure: Adherence Outcomes: Adherence to COMB-R Medication Management Sessions
timeFrame: Weeks 1, 6, 12 and 24
measure: Adherence Outcomes: Adherence to Study Visits
timeFrame: Weeks 0, 1, 6, 12, 24, 36 and 48
measure: Depression Outcomes: Quick Inventory of Depression Symptomatology Self-Report (QIDS-SR) Score Over 48 Weeks.
timeFrame: Week 48
measure: Depression Outcomes: Quick Inventory of Depression Symptomatology Self-Report (QIDS-SR) Response to Treatment Over 48 Weeks, Defined as a Decrease in QIDS-SR Score by > 50%
timeFrame: Week 0 and Week 48
measure: Depression Outcomes: Quick Inventory of Depression Symptomatology Self-Report (QIDS-SR) Score Remission Over 48 Weeks
timeFrame: Week 48
measure: Effect of Demographic, Behavioral, and Biological Modifiers on Depression Outcomes: Quick Inventory of Depression Symptomatology (QIDS-SR) Score
timeFrame: Week 48
measure: Effect of Demographic, Behavioral, and Biological Modifiers on Depression Outcomes: Response to Treatment
timeFrame: Week 0 and Week 48
measure: Effect of Demographic, Behavioral, and Biological Modifiers on Depression Outcomes: Remission
timeFrame: Week 48
measure: Behavioral Risk Outcomes: Alcohol Use - Ever Used
timeFrame: Weeks 24 and 48
measure: Behavioral Risk- Alcohol Use - Past 3 Months Regular Use Frequency
timeFrame: weeks 24 and 48
measure: Behavioral Risk - Alcohol Use - Number of Drinks Per Day
timeFrame: weeks 24 and 48
measure: Behavioral Risk - Alcohol Use - Binge Drinking
timeFrame: Weeks 24 and 48
measure: Behavioral Risk Outcomes: Tobacco Use- Ever Used
timeFrame: Weeks 24 and 48
measure: Behavioral Risk - Tobacco Use - Past 3 Months Regular Use Frequency
timeFrame: weeks 24 and 48
measure: Behavioral Risk Outcomes: Drug Use - Ever Used
timeFrame: Weeks 24 and 48
measure: Behavioral Risk - Drug Use - Past 3 Months Regular Frequency of Use
timeFrame: week 24 and 48
measure: Behavioral Risk Outcomes: Sex-Risk Behaviors - Sex as Exchange Commodity
timeFrame: Weeks 24 and 48
measure: Behavioral Risk Outcomes: Sex-Risk Behaviors - Importance of Using Condom
timeFrame: weeks 24 and 48
measure: Behavioral Risk- Sex Risk Behaviors - Confidence in Condom Use
timeFrame: Week 24 and 48
measure: Behavioral Risk - Sex Risk Behaviors - Number of Sexual Partners in Past Three Months
timeFrame: week 24 and 48
measure: Behavioral Risk - Sex Risk Behaviors. Low Use Frequency of Condom Use in Last Three Months - Main Partner
timeFrame: week 24 and 48
measure: Behavioral Risk - Sex Risk Behavior - Low Use Frequency of Condom Use in Past 3 Months - Other Partner
timeFrame: week 24 and 48
measure: To Describe the Implementation Fidelity at COMB-R Sites and the Counseling Strategies and Medication Patterns at ESC Sites: The Total Numbers of Counseling Sessions
timeFrame: over 24 weeks
measure: Implementation Fidelity (COMB-R Sites) - Count of Participants Having Been Administered Various COMB-R Counseling Approaches
timeFrame: over 24 Weeks
measure: Counseling Strategies (ESC Sites) - Count of Participants Having Been Administered Various ESC Counseling Approaches
timeFrame: Over 24 weeks
measure: Implementation Fidelity (COMB-R Sites); Medication Management - Number of Sessions
timeFrame: Over 24 Weeks
measure: Implemental Fidelity (COMB-R) - Medication Management - Stages
timeFrame: week 1, 6, 12, 24
measure: Acceptability: Frequency of Psychiatric Medication Use - Percent of Participants on Psychiatric Medications
timeFrame: week 24
measure: Acceptability - Frequency of Psychiatric Medication Use - Percent of Study Time on Psychiatric Medications Through Week 24
timeFrame: over 24 weeks
measure: Acceptability: Number of Interim Visits - Counseling Sessions
timeFrame: Over 24 Weeks
measure: Acceptability - Number of Interim Medication Management Visits (COMB-R)
timeFrame: Over 24 weeks
measure: COMB-R and ESC Acceptability Among Participants
timeFrame: Week 24
measure: COMB-R and ESC Acceptability Among Counseling Clinicians
timeFrame: Week 24
measure: COMB-R MM and ESC Acceptability Among Prescribing Clinicians
timeFrame: Week 24
measure: Grade 3 or Higher Adverse Events (AE), Psychological Hospitalizations, and Suicide Attempts
timeFrame: Over 24 Weeks
measure: Grade 3 or Higher Adverse Events (AE), Psychological Hospitalizations, and Suicide Attempts
timeFrame: Over 48 weeks
Other outcomes:
Locations:
city: Alhambra
country: United States
facility: University of Southern California - MCA Center (CRS 5048),
state: California
city: La Jolla
country: United States
facility: University California, San Diego (CRS 4601)
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA (CRS 5112)
state: California
city: Aurora
country: United States
facility: Children's Hospital of Colorado (CRS 5052)
state: Colorado
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic and Treatment Center (CRS 5055)
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine (CRS 5030)
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center (CRS 5083)
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine (CRS 5092)
state: Maryland
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital Center (CRS 5114)
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center (CRS 5013)
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center (CRS 5040)
state: New York
city: Memphis
country: United States
facility: St Jude Children's Research Hospital (CRS 6501)
state: Tennessee
city: Houston
country: United States
facility: Texas Children's/Baylor (CRS 3801)
state: Texas
Study officials:
affiliation: Rhode Island Hospital; Brown University
name: Larry Brown, MD
role: STUDY_CHAIR
References:
citation: Brown LK, Kennard BD, Emslie GJ, Mayes TL, Whiteley LB, Bethel J, Xu J, Thornton S, Tanney MR, Hawkins LA, Garvie PA, Subramaniam GA, Worrell CJ, Stoff LW; Adolescent Trials Network for HIVAIDS Interventions. Effective Treatment of Depressive Disorders in Medical Clinics for Adolescents and Young Adults Living With HIV: A Controlled Trial. J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):38-46. doi: 10.1097/QAI.0000000000000803.
citation: Bernstein IH, Rush AJ, Trivedi MH, Hughes CW, Macleod L, Witte BP, Jain S, Mayes TL, Emslie GJ. Psychometric properties of the Quick Inventory of Depressive Symptomatology in adolescents. Int J Methods Psychiatr Res. 2010 Dec;19(4):185-94. doi: 10.1002/mpr.321.