Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)
  CBT-AD is a behavioral intervention administered either in person or via Zoom. Each session lasts approximately 50 minutes. Participants will receive up to 12 individually delivered sessions over 4 months. Participants receive up to three individually delivered booster sessions through 6 months.
• Поведенческое Antiretroviral Therapy (ART) Adherence Counseling
  This treatment involves a single session integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.

Первичные конечные точки

• Change in resting state activation of the negative valence system [Срок оценки: 6 Months]
• Change in connectivity of the negative valence system [Срок оценки: 6 Months]

Вторичные конечные точки (7)

• Depressive Symptoms [Срок оценки: 6 Months]
• Alterations in gut microbiota [Срок оценки: 4 months]
• Conserved transcriptional response to adversity (CTRA) leukocyte signaling pathway [Срок оценки: 4 Months]
• Soluble Markers of Microbial Translocation [Срок оценки: 4 Months]
• Soluble Markers of Immune Activation and Inflammation [Срок оценки: 4 Months]
• Soluble Markers of Dysregulated Neurotransmitter Synthesis [Срок оценки: 4 Months]
• Neurocognitive Functioning [Срок оценки: 6 Months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 2 центра

• University of Miami Neuroimaging Facility — Coral Gables
• Care Resource - Midtown Miami — Miami

Идентификаторы

NCT: NCT05136703 · 20210773 · R01MH128868

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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