IMPAACT 2002: Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression Among Youth Living With HIV in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 13
- 主要终点
- Biological Outcomes: Cluster of Differentiation 4 (CD4) Cell Count at Week 24
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
COMB-R
Health and Wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention
干预措施: Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm (Behavioral)
Enhanced Standard of Care
Enhanced Standard of Care (ESC)
干预措施: Enhanced Standard of Care (Behavioral)
结局指标
主要结局
Biological Outcomes: Cluster of Differentiation 4 (CD4) Cell Count at Week 24
时间窗: 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.
Depression Outcomes: Remission, Defined as a QIDS-SR Score <= 5
时间窗: Week 24
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.
Depression Outcomes: Response to Treatment, Defined as a Decrease in QIDS-SR Score by >50%
时间窗: Week 0 and Week 24
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.
Depression Outcomes: Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR) Score
时间窗: Week 24
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.
Biological Outcomes: Plasma HIV RNA Level at Week 24
时间窗: 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.
次要结局
- 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 - How Good Participant Was at Taking Medications as Instructed(Weeks 24 and 48)
- Adherence Outcomes: Adherence to COMB-R Medication Management Sessions(Weeks 1, 6, 12 and 24)
- Behavioral Risk Outcomes: Tobacco Use- Ever Used(Weeks 24 and 48)
- Adherence Outcomes: Adherence to Anti-HIV Medications - How Good Participant Was at Taking Medicines as Instructed(Weeks 24 and 48)
- 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%(Week 0 and Week 48)
- Behavioral Risk Outcomes: Alcohol Use - Ever Used(Weeks 24 and 48)
- 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 Psychiatric Medications - Number of Days in Last 30 With Any Missed Doses(Weeks 24 and 48)
- Behavioral Risk - Alcohol Use - Binge Drinking(Weeks 24 and 48)
- Behavioral Risk- Sex Risk Behaviors - Confidence in Condom Use(Week 24 and 48)
- Behavioral Risk - Sex Risk Behaviors. Low Use Frequency of Condom Use in Last Three Months - Main Partner(week 24 and 48)
- Effect of Demographic, Behavioral, and Biological Modifiers on Depression Outcomes: Response to Treatment(Week 0 and Week 48)
- Effect of Demographic, Behavioral, and Biological Modifiers on Depression Outcomes: Remission(Week 48)
- Behavioral Risk- Alcohol Use - Past 3 Months Regular Use Frequency(weeks 24 and 48)
- Behavioral Risk Outcomes: Drug Use - Ever Used(Weeks 24 and 48)
- Behavioral Risk - Drug Use - Past 3 Months Regular Frequency of Use(week 24 and 48)
- Behavioral Risk Outcomes: Sex-Risk Behaviors - Sex as Exchange Commodity(Weeks 24 and 48)
- Adherence Outcomes: Adherence to Psychiatric Medications - How Often Did Participant Take Medicines as Instructed(Weeks 24 and 48)
- Adherence Outcomes: Adherence to Psychotherapy Sessions(Weeks 1, 6, 12 and 24)
- Adherence Outcomes: Adherence to Study Visits(Weeks 0, 1, 6, 12, 24, 36 and 48)
- Depression Outcomes: Quick Inventory of Depression Symptomatology Self-Report (QIDS-SR) Score Over 48 Weeks.(Week 48)
- Depression Outcomes: Quick Inventory of Depression Symptomatology Self-Report (QIDS-SR) Score Remission Over 48 Weeks(Week 48)
- Effect of Demographic, Behavioral, and Biological Modifiers on Depression Outcomes: Quick Inventory of Depression Symptomatology (QIDS-SR) Score(Week 48)
- Behavioral Risk - Alcohol Use - Number of Drinks Per Day(weeks 24 and 48)
- Behavioral Risk - Tobacco Use - Past 3 Months Regular Use Frequency(weeks 24 and 48)
- Behavioral Risk Outcomes: Sex-Risk Behaviors - Importance of Using Condom(weeks 24 and 48)
- Behavioral Risk - Sex Risk Behaviors - Number of Sexual Partners in Past Three Months(week 24 and 48)
- Implementation Fidelity (COMB-R Sites) - Count of Participants Having Been Administered Various COMB-R Counseling Approaches(over 24 Weeks)
- Counseling Strategies (ESC Sites) - Count of Participants Having Been Administered Various ESC Counseling Approaches(Over 24 weeks)
- COMB-R and ESC Acceptability Among Counseling Clinicians(Week 24)
- Implementation Fidelity (COMB-R Sites); Medication Management - Number of Sessions(Over 24 Weeks)
- Acceptability - Frequency of Psychiatric Medication Use - Percent of Study Time on Psychiatric Medications Through Week 24(over 24 weeks)
- 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(over 24 weeks)
- Acceptability - Number of Interim Medication Management Visits (COMB-R)(Over 24 weeks)
- COMB-R and ESC Acceptability Among Participants(Week 24)
- COMB-R MM and ESC Acceptability Among Prescribing Clinicians(Week 24)
- Behavioral Risk - Sex Risk Behavior - Low Use Frequency of Condom Use in Past 3 Months - Other Partner(week 24 and 48)
- Implemental Fidelity (COMB-R) - Medication Management - Stages(week 1, 6, 12, 24)
- Acceptability: Frequency of Psychiatric Medication Use - Percent of Participants on Psychiatric Medications(week 24)
- Acceptability: Number of Interim Visits - Counseling Sessions(Over 24 Weeks)
- Grade 3 or Higher Adverse Events (AE), Psychological Hospitalizations, and Suicide Attempts(Over 48 weeks)
- Grade 3 or Higher Adverse Events (AE), Psychological Hospitalizations, and Suicide Attempts(Over 24 Weeks)