N/A
N=156
IMPAACT 2002: Cognitive Behavioral Therapy and Medication Management for Treatment of Depression in US Youth With HIV
HIV · Depression
Bottom Line
View on ClinicalTrials.gov: NCT02939131 ↗Enrolled (actual)
156
Serious AEs
7.7%
Results posted
Sep 2020
Primary outcome: Primary: Depression Outcomes: Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR) Score — 6.7; 10.6 units on a scale — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm (Behavioral); Enhanced Standard of Care (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression Outcomes: Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR) Score |
6.7; 10.6 | 0.01 sig |
| PRIMARY Depression Outcomes: Response to Treatment, Defined as a Decrease in QIDS-SR Score by >50% |
62.3; 17.9 | <0.001 sig |
| PRIMARY Depression Outcomes: Remission, Defined as a QIDS-SR Score <= 5 |
47.9; 17.0 | 0.01 sig |
| PRIMARY Biological Outcomes: Cluster of Differentiation 4 (CD4) Cell Count at Week 24 |
703; 683 | 0.86 |
| PRIMARY Biological Outcomes: Plasma HIV RNA Level at Week 24 |
2.23; 2.06 | 0.66 |
| SECONDARY Adherence Outcomes: Adherence to Anti-HIV Medications - Number of Days in Last 30 With Any Missed Doses |
4.4; 2.3; 4.8; 4.7 | 0.04 sig |
| SECONDARY Adherence Outcomes: Adherence to Anti-HIV Medications - How Good Participant Was at Taking Medicines as Instructed |
4.3; 4.7; 4.4; 4.2 | 0.27 |
| SECONDARY Adherence Outcomes: Adherence to Anti-HIV Medications - How Often Did Participant Take Medications as Instructed |
4.8; 5.2; 4.8; 4.5 | 0.14 |
| SECONDARY Adherence Outcomes: Adherence to Psychiatric Medications - Number of Days in Last 30 With Any Missed Doses |
3.4; 1.2; 3.6; 6.4 | 0.05 |
| SECONDARY Adherence Outcomes: Adherence to Psychiatric Medications - How Good Participant Was at Taking Medications as Instructed |
4.5; 5.2; 4.5; 4.0 | 0.13 |
| SECONDARY Adherence Outcomes: Adherence to Psychiatric Medications - How Often Did Participant Take Medicines as Instructed |
4.8; 5.4; 5.1; 4.3 | 0.07 |
| SECONDARY Adherence Outcomes: Adherence to Psychotherapy Sessions |
3.5; 3.7 | 0.44 |
| SECONDARY Adherence Outcomes: Adherence to COMB-R Medication Management Sessions |
3.6 | — |
| SECONDARY Adherence Outcomes: Adherence to Study Visits |
4.7; 4.7; 6.4; 6.5 | 0.67 |
| SECONDARY Depression Outcomes: Quick Inventory of Depression Symptomatology Self-Report (QIDS-SR) Score Over 48 Weeks. |
7.09; 9.08 | 0.14 |
| SECONDARY 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% |
58.7; 33.4 | 0.05 |
| SECONDARY Depression Outcomes: Quick Inventory of Depression Symptomatology Self-Report (QIDS-SR) Score Remission Over 48 Weeks |
43.7; 27.5 | 0.24 |
| SECONDARY Effect of Demographic, Behavioral, and Biological Modifiers on Depression Outcomes: Quick Inventory of Depression Symptomatology (QIDS-SR) Score |
8.15; 6.11; 6.78; 11.53; 6.57; 10.13 | 0.01 sig |
| SECONDARY Effect of Demographic, Behavioral, and Biological Modifiers on Depression Outcomes: Response to Treatment |
54.95; 67.30; 64.58; 7.82; 71.11; 22.22 | 0.01 sig |
| SECONDARY Effect of Demographic, Behavioral, and Biological Modifiers on Depression Outcomes: Remission |
44.54; 56.59; 42.13; 7.82; 31.11; 22.22 | 0.09 |
| SECONDARY Behavioral Risk Outcomes: Alcohol Use - Ever Used |
75.8; 66.0; 70.4; 76.6 | 0.26 |
| SECONDARY Behavioral Risk- Alcohol Use - Past 3 Months Regular Use Frequency |
37.0; 32.3; 56.9; 30.2 | 0.71 |
| SECONDARY Behavioral Risk - Alcohol Use - Number of Drinks Per Day |
1.7; 2.8; 2.1; 1.9 | 0.09 |
| SECONDARY Behavioral Risk - Alcohol Use - Binge Drinking |
1.0; 1.1; 0.8; 0.8 | 0.87 |
| SECONDARY Behavioral Risk Outcomes: Tobacco Use- Ever Used |
42.5; 39.3; 48.8; 34.1 | 0.77 |
| SECONDARY Behavioral Risk - Tobacco Use - Past 3 Months Regular Use Frequency |
65.4; 50.2; 62.3; 41.7 | 0.09 |
| SECONDARY Behavioral Risk Outcomes: Drug Use - Ever Used |
70.1; 62.2; 69.2; 56.2; 19.8; 15.1 | 0.41 |
| SECONDARY Behavioral Risk - Drug Use - Past 3 Months Regular Frequency of Use |
57.3; 47.2; 64.9; 65.0; 27.8; 3.1 | 0.53 |
| SECONDARY Behavioral Risk Outcomes: Sex-Risk Behaviors - Sex as Exchange Commodity |
31.6; 18.2; 24.2; 20.4 | 0.29 |
| SECONDARY Behavioral Risk Outcomes: Sex-Risk Behaviors - Importance of Using Condom |
83.6; 80.7; 80.2; 84.9 | 0.71 |
| SECONDARY Behavioral Risk- Sex Risk Behaviors - Confidence in Condom Use |
78.0; 70.7; 78.4; 80.8 | 0.23 |
| SECONDARY Behavioral Risk - Sex Risk Behaviors - Number of Sexual Partners in Past Three Months |
1.9; 1.4; 1.6; 1.2 | 0.24 |
| SECONDARY Behavioral Risk - Sex Risk Behaviors. Low Use Frequency of Condom Use in Last Three Months - Main Partner |
31.9; 40.1; 26.4; 48.2 | 0.57 |
| SECONDARY Behavioral Risk - Sex Risk Behavior - Low Use Frequency of Condom Use in Past 3 Months - Other Partner |
28.9; 35.7; 14.4; 52.1 | 0.65 |
| SECONDARY 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 |
11.5; 9.0 | 0.33 |
| SECONDARY Implementation Fidelity (COMB-R Sites) - Count of Participants Having Been Administered Various COMB-R Counseling Approaches |
80; 77; 63; 79; 70; 68 | — |
| SECONDARY Counseling Strategies (ESC Sites) - Count of Participants Having Been Administered Various ESC Counseling Approaches |
47; 35; 24; 15; 12; 12 | — |
| SECONDARY Implementation Fidelity (COMB-R Sites); Medication Management - Number of Sessions |
5.3 | — |
| SECONDARY Implemental Fidelity (COMB-R) - Medication Management - Stages |
54; 19; 1; 4; 46; 22 | — |
| SECONDARY Acceptability: Frequency of Psychiatric Medication Use - Percent of Participants on Psychiatric Medications |
49.1; 30.4; 44.9; 27.5; 40.7; 18.4 | 0.06 |
| SECONDARY Acceptability - Frequency of Psychiatric Medication Use - Percent of Study Time on Psychiatric Medications Through Week 24 |
69.3; 73.1; 60.9; 62.8; 39.2; 55.8 | 0.77 |
| SECONDARY Acceptability: Number of Interim Visits - Counseling Sessions |
7.9; 5.3 | 0.29 |
| SECONDARY Acceptability - Number of Interim Medication Management Visits (COMB-R) |
1.7 | — |
| SECONDARY COMB-R and ESC Acceptability Among Participants |
3.67; 3.47 | 0.03 sig |
| SECONDARY COMB-R and ESC Acceptability Among Counseling Clinicians |
2.26; 2.33 | 0.69 |
| SECONDARY COMB-R MM and ESC Acceptability Among Prescribing Clinicians |
3.05; 2.40 | 0.004 sig |
| SECONDARY Grade 3 or Higher Adverse Events (AE), Psychological Hospitalizations, and Suicide Attempts |
13.12; 12.98; 19.22; 13.57; 6.88; 3.87 | 0.98 |
| SECONDARY Grade 3 or Higher Adverse Events (AE), Psychological Hospitalizations, and Suicide Attempts |
13.12; 12.98; 19.22; 13.57; 6.88; 3.87 | 0.98 |
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).
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
Data sourced from ClinicalTrials.gov (NCT02939131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.