IMPAACT 2002: Cognitive Behavioral Therapy and Medication Management for Treatment of Depression in US Youth With HIV

NCT02939131 | Completed Results DMC

• 4 other identifiers: IMPAACT 2002UM1AI068632UM1AI068616UM1AI106716
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 13

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).

Conditions

HIV; Depression

Keywords

Cognitive Behavioral Therapy; Medication Management

Outcome Measures

Primary Outcomes (5)

• Depression Outcomes: Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR) Score

  The QIDS-SR ranges from 0-27 and assesses the severity and number of depression symptoms. Data completed through the Audio Computer Assisted Interview (ACASI) system are used for this outcome. A lower score indicates fewer depression symptoms and lower depression symptom severity. Scores for all participants at a site were averaged. The site-specific averages were then analyzed.

  Week 24

• Depression Outcomes: Response to Treatment, Defined as a Decrease in QIDS-SR Score by >50%

  We are assessing the percentage of participants with a response to treatment.The percentage of participants at each site with a response was calculated. These percentages were averaged for each treatment and the treatment averages were compared. A response to treatment is considered a decrease in Quick Inventory of Depression Symptomatology, Self Report (QIDS-SR) from Study entry to Week 24 by more than 50%. The week 0 value is generally considered the entry value. Priority is given to the ACASI score at week 0. In certain cases, the week 1 ACASI value is used if there is no ACASI score at week 0, but there is one at week 1. Paper form scores are used for "study entry" if there is no ACASI record, with the value at week 0 prioritized over the value at week 1. Otherwise, ACASI data are used for this outcome. The QIDS-SR is scored from 0 to 27 with a lower score indicating less symptomatology.

  Week 0 and Week 24

• Depression Outcomes: Remission, Defined as a QIDS-SR Score <= 5

  We computed the percentage of participants at each site with remission and then compared the percentages. Remission is defined as a Quick Inventory of Depression Symptomatology, self-report (QIDS-SR) score \<= 5. ACASI data are used for this outcome. The QIDS-SR scale is from 0-27 with a lower score indicating tess symptomatology.

  Week 24

• Biological Outcomes: Cluster of Differentiation 4 (CD4) Cell Count at Week 24

  CD4 cell counts are cells/microL (uL). CD4 cell counts of all participants at a site were averaged. The averages were then analyzed.

  Week 24

• Biological Outcomes: Plasma HIV RNA Level at Week 24

  Plasma HIV RNA data are calculated on the log10 scale as log10(RNA copies/mL) For this analysis, HIV-1 RNA values (copies per mL) that were censored below the lower limit of quantification (LLQ) were imputed to be equal to the LLQ - 1. The LLQ was considered to be 40 copies/mL. Viral load was calculated on the log10 scale as log10(RNA copies/mL). Viral load suppression was also measured as copies \< 40. The log10 (RNA copies/mL) values were averaged by site and those averages were analyzed.

  Week 24

Secondary Outcomes (43)

• Adherence Outcomes: Adherence to Anti-HIV Medications - Number of Days in Last 30 With Any Missed Doses

  Weeks 24 and 48

• Adherence Outcomes: Adherence to Anti-HIV Medications - How Good Participant Was at Taking Medicines as Instructed

  Weeks 24 and 48

• Adherence Outcomes: Adherence to Anti-HIV Medications - How Often Did Participant Take Medications as Instructed

  Weeks 24 and 48

• Adherence Outcomes: Adherence to Psychiatric Medications - Number of Days in Last 30 With Any Missed Doses

  Weeks 24 and 48

• Adherence Outcomes: Adherence to Psychiatric Medications - How Good Participant Was at Taking Medications as Instructed

  Weeks 24 and 48

Study Arms (2)

COMB-R

EXPERIMENTAL

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

Enhanced Standard of Care

ACTIVE COMPARATOR

Enhanced Standard of Care (ESC)

Behavioral: Enhanced Standard of Care

Interventions

Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm BEHAVIORAL

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).

COMB-R

Enhanced Standard of Care BEHAVIORAL

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.

Enhanced Standard of Care

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (13)

University of Southern California - MCA Center (CRS 5048),

Alhambra, California, 91803, United States

Location

University California, San Diego (CRS 4601)

La Jolla, California, 92093, United States

Location

David Geffen School of Medicine at UCLA (CRS 5112)

Los Angeles, California, 90095, United States

Location

Children's Hospital of Colorado (CRS 5052)

Aurora, Colorado, 80045, United States

Location

Children's Diagnostic and Treatment Center (CRS 5055)

Fort Lauderdale, Florida, 33316, United States

Location

Emory University School of Medicine (CRS 5030)

Atlanta, Georgia, 30308, United States

Location

Rush University Medical Center (CRS 5083)

Chicago, Illinois, 60612, United States

Location

Johns Hopkins University School of Medicine (CRS 5092)

Baltimore, Maryland, 21287, United States

Location

Stony Brook University Medical Center (CRS 5040)

Stony Brook, New York, 11794, United States

Location

Bronx-Lebanon Hospital Center (CRS 5114)

The Bronx, New York, 10457, United States

Location

Jacobi Medical Center (CRS 5013)

The Bronx, New York, 10461, United States

Location

St Jude Children's Research Hospital (CRS 6501)

Memphis, Tennessee, 38105, United States

Location

Texas Children's/Baylor (CRS 3801)

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 26761270 BACKGROUND

• 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.

  PMID: 20683845 BACKGROUND

Related Links

• The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (AE) (DAIDS AE Grading Table), Corrected Version 2.1, July 2017
• Richard M Selik, Eve D Mokotoff, Bernard Branson, et al. Revised Surveillance Case Definition for HIV Infection - United States, 2014. Morbidity and Mortality Weekly Report (MMWR) 2014; 63 (No. 3):7
• Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS Expedited Adverse Events (EAE) Manual), Version 2.0, January 2010

MeSH Terms

Conditions

Depression

Interventions

Health

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Results Point of Contact

• Title: IMPAACT Clinicaltrials.gov Coordinator
• Organization: Family Health International (FHI 360)

IMPAACT.ctgov@fstrf.org

(919) 405-1429

Study Officials

• Larry Brown, MD

  Rhode Island Hospital; Brown University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 19, 2016
• Study Start: March 6, 2017
• Primary Completion: September 12, 2019
• Study Completion: January 21, 2020
• Last Updated: March 3, 2021
• Results First Posted: September 22, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
• Access Criteria: * With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT network, * For what types of analyses? To achieve aims in the proposal approved by the IMPAACT network. * By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.

Locations

US (13)