A Randomized, Controlled Trial Assessing the Effects of Cognitive Behavioral Therapy to Prevent Worsening Insulin Resistance in Depressed, Virologically-Suppressed, Antiretroviral-Treated Adults With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in HOMA-IR at 24 weeks
研究概览
简要总结
The goal of this clinical trial is to learn if depression treatment improves insulin resistance, or how the body uses insulin to lower blood sugar, in people with HIV on HIV treatment. Researchers will compare an internet-based (online) depression treatment program called cognitive behavioral therapy with depression education. In the online group, participants will undergo 9 weekly treatment sessions. The education group will receive learning materials about depression and will be monitored every month. All participants will have 4 study visits over 12 months.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection, documented as listed clinically in the participant's electronic medical record by any of the following tests: (1) any licensed rapid HIV test, (2) HIV enzyme test kit at any time prior to study entry, (3) at least one detectable HIV-1 antigen, or (4) at least one detectable plasma HIV-1 RNA viral load.
- •Age ≥ 18 years.
- •Ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to Screening
- •Meets the depression definition for this trial:
- •(1) repeat PHQ-9 ≥10100 result at the Screening Visit (suggesting moderate to severe depressive symptoms), AND
- •(2) PHQ-9 depressive disorder diagnosis (2 or more of the 9 depressive symptoms, including depressed mood or anhedonia, present in the past 2 weeks), AND
- •(3) functional impairment (using the tenth PHQ-9 item assessing social/occupational impairment), AND
- •(4) no evidence that the direct physiological effects of a substance, medication, or medical condition clearly account for the depressive symptoms, AND
- •(5) no bipolar or psychotic disorders
- •NOTE: The use of antidepressant medications is not exclusionary.
- •HbA1c < 6.5% at Screening
- •HIV-1 RNA level < 75 copies/mL at Screening
- •NOTE: There are no CD4 cell count eligibility criteria for this trial.
排除标准
- •Inability to complete written, informed consent
- •Inability to read and understand English as seen on a computer screen
- •Diagnosed diabetes mellitus or any previously recorded HbA1c ≥6.5%
- •History of bipolar disorder or a psychotic disorder, including schizophrenia
- •NOTE: Depressive disorders are not exclusionary.
- •Incarceration at the time of any study visit
- •Active suicidality at Entry, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions (for Question #3, the previous attempt must be within the past 10 years) on the Patient Suicidality Form (see Appendix).
- •Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, or other collagen vascular diseases).
- •NOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation
- •End stage renal disease requiring renal replacement therapy (dialysis, transplantation).
- •Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.
- •NOTE: Localized treatment for skin cancers is not exclusionary.
- •Therapy for serious medical illnesses within 14 days prior to the Entry Visit
- •NOTE: Therapy for serious medical illnesses that overlaps with a study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation.
- •Pregnancy or breastfeeding during the study.
- •Receipt of investigational agents, cytotoxic chemotherapy, systemic immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit
- •NOTE: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled/nasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors
- •NOTE: Use of NSAIDS and aspirin are allowed
- •Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
研究组 & 干预措施
Active Control (AC)
Our AC comparator will include depression education and depressive symptom monitoring along with usual depression care as provided by the participants HIV clinicians. Trial staff will fist have a 30-minute call with AC participants to review depression materials, including their HIV provider's role in its management and treatment options and also provide a list of local mental health services. There are no care restrictions by the primary HIV clinicians. Trial staff will call AC participants every 4 weeks to assess depressive symptoms (PHQ-9) and will notify clinic staff to encourage additional care when indicated.
干预措施: Active Control (AC) (Behavioral)
Internet Cognitive Behavioral Therapy (iCBT-D)
Intervention participants will receive the empirically supported, HIPAA-compliant, therapist-assisted iCBT-D called Good Days Ahead (GDA; MindStreet, Inc.).
GDA uses an interactive, multimedia format (including video, exercises, calls to action, newsfeeds, and customized feedback) to deliver nine 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT. Topics include identifying and modifying automatic thoughts, using behavioral activation and other behavioral methods, identifying and modifying schemas, using effective coping strategies, and employing other core CBT methods.
干预措施: Internet cognitive behavioral therapy (iCBT-D) (Behavioral)
结局指标
主要结局
Change from baseline in HOMA-IR at 24 weeks
时间窗: 24 weeks
Homeostasis Model Assessment-Insulin, where higher values indicate greater insulin resistance
次要结局
未报告次要终点
研究者
Samir K. Gupta, MD
Professor of Medicine
Indiana University