Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Change in connectivity of the negative valence system
研究概览
简要总结
The purpose of this randomized controlled trial is to understand how a cognitive-behavioral treatment (a form of psychological treatment) for depression changes the gut microbiome (micro-organisms that regulate the health of the gut), immune system, and the brain functioning in people living with HIV.
详细描述
The overarching goal of this randomized controlled trial (RCT) is to identify the causal pathways that drive depressive symptoms among people with HIV (PWH). The scientific premise is that evidence-based depression treatment is an innovative, experimental probe to determine the neural substrates of depression and mechanistic relevance of microbiome-gut-brain (MGB) axis changes during and after Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) on brain and behavioral function. The proposed causal pathway is that reductions in depressive symptoms following the delivery of CBT-AD treatment will trigger a cascade of alterations in the MGB axis. Specifically, CBT-AD related decreases in depressive symptoms will induce alterations in gut dysbiosis, decrease microbial translocation, and improve soluble neuroactive markers of peripheral immune dysregulation. Our efforts to elucidate the immunologic mechanisms whereby CBT-AD could improve neurobehavioral outcomes will also focus on an established leukocyte signaling pathway, the Conserved Transcriptional Response to Adversity (CTRA), which has been shown to be responsive to behavioral interventions and psychosocial factors outside of HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, 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
- •Age 18 or older
- •Speaks and reads English
- •Verified HIV+ status with antiretroviral medications bearing his/her name
- •Current diagnosis on Major Depressive Disorder (MDD) using a structured clinical interview (DIAMOND) or Hamilton Rating Scale for Depression scores of 7 or greater
- •If prescribed antidepressants, on a stable regimen and dose for at least 2 months
- •Suppressed HIV viral load (< 200 copies/mL)
- •Able to complete Functional Magnetic Resonance Imaging (fMRI) scans (i.e., no claustrophobia, no metal implants, no pacemaker, and BMI < 40)
排除标准
- •Unable to provide informed consent
- •Active, untreated major mental illness
- •Pregnancy at baseline
- •Received CBT for depression in the past 2 years
- •5. Otherwise eligible but does not complete the run-in period that includes the baseline assessment, biospecimen collection, the fMRI visit, and a separately scheduled randomization visit
研究组 & 干预措施
Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)
Participants randomized to receive CBT-AD immediately will complete up to 15 individual sessions (12 session with 3 booster sessions) focused on depression and one session of ART Adherence counseling during the four months following randomization.
干预措施: Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) (Behavioral)
Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)
Participants randomized to receive CBT-AD immediately will complete up to 15 individual sessions (12 session with 3 booster sessions) focused on depression and one session of ART Adherence counseling during the four months following randomization.
干预措施: Antiretroviral Therapy (ART) Adherence Counseling (Behavioral)
Wait-List Control (WLC)
Participants randomized to the WLC condition will receive one session of ART adherence counseling immediately following randomization. After six months, WLC participants will have the opportunity to receive 15 individually delivered CBT-AD sessions (12 sessions and 3 booster sessions) focused on depression.
干预措施: Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) (Behavioral)
Wait-List Control (WLC)
Participants randomized to the WLC condition will receive one session of ART adherence counseling immediately following randomization. After six months, WLC participants will have the opportunity to receive 15 individually delivered CBT-AD sessions (12 sessions and 3 booster sessions) focused on depression.
干预措施: Antiretroviral Therapy (ART) Adherence Counseling (Behavioral)
结局指标
主要结局
Change in connectivity of the negative valence system
时间窗: 6 Months
Measured by functional Magnetic Resonance Imaging (fMRI)
Change in resting state activation of the negative valence system
时间窗: 6 Months
Measured by functional Magnetic Resonance Imaging (fMRI)
次要结局
- Depressive Symptoms(6 Months)
- Soluble Markers of Microbial Translocation(4 Months)
- Alterations in gut microbiota(4 months)
- Soluble Markers of Dysregulated Neurotransmitter Synthesis(4 Months)
- Neurocognitive Functioning(6 Months)
- Conserved transcriptional response to adversity (CTRA) leukocyte signaling pathway(4 Months)
- Soluble Markers of Immune Activation and Inflammation(4 Months)
研究者
Adam Carrico, PhD
Professor
Florida International University