Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids

Обзор

Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth.

Вмешательства

• Поведенческое Moderate Intensity Exercise
  Participants randomized to the active (moderate intensity) exercise condition will complete a 3-minute warm-up at low speed on a treadmill. Speed and incline will be increased in 3-minute increments until moderate-intensity exercise, defined as participants staying within a zone of 60-80% AAMHR with the target being to attain and maintain 70-75% AAMHR while briskly walking and/or jogging depending on current fitness status, is reached for a total of 30 min.

Первичные конечные точки

• Skin Conductance Responding (SCR) [Срок оценки: Throughout study completion (3 days)]
• Unconditioned Stimulus (US) Expectancy Ratings [Срок оценки: Throughout study completion (3 days)]
• Fear extinction neural circuitry: Functional activation and coupling [Срок оценки: Neuroimaging will occur during the fear extinction recall phase on Day 3]
• Endocannabinoid (eCB) Concentrations [Срок оценки: eCB concentrations will be measured in plasma and saliva immediately before and after the exercise or control condition on Day 2]

Вторичные конечные точки (3)

• Fear Ratings [Срок оценки: Throughout study completion (3 days)]
• Approach/Avoidance Behavior [Срок оценки: Throughout study completion (3 days)]
• Amygdala response during extinction recall [Срок оценки: Neuroimaging will occur during the fear extinction recall phase on Day 3]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and available for the duration of the study
• 14-17 years of age upon enrollment
• Right-handed
• In good general health as evidenced by medical history
• Adolescent and parent/guardian are English-speaking, as study assessments are in English
• Availability of a parent or legal guardian who is willing to provide consent and attend all study visits

Критерии исключения

• Traumatic brain injury with ongoing symptoms
• Sensory (e.g., hearing) or physical (e.g., motor, balance) impairment or significant developmental delay
• MRI participants: MRI contraindication (e.g., braces, implants, claustrophobia)
• Any condition that would contraindicate blood draws (e.g., hemophilia, sickle cell)
• Past or current diagnosis or presence of likely neurological disorder (e.g., epilepsy), psychotic disorder (e.g., schizophrenia, schizoaffective disorder), or bipolar disorder
• Severe/unstable medical condition (e.g., diabetes, rheumatoid arthritis)
• Current (past 1-month) use of cannabis or cannabinoid products including CBD unless willing to stop for at least 4 weeks prior to entering the study
• Currently pregnant, lactating, or positive pregnancy test at screening visit
• Current homicidal thoughts or suicide attempt in the past year
• Current suicidal thoughts requiring immediate intervention
• Concurrent use (past 6 weeks) of oral contraceptives
• Diagnosed or probable substance use disorder (past 1-month)
• Positive drug test at baseline visit (e.g., THC, cocaine)
• Moderate/severe drug or alcohol use in the past 8 weeks
• Current or recent (past 1-month) COVID-19 diagnosis or febrile illness
• Treatment with investigational drug or intervention (past 1-month)
• Current smoker, vaper, or tobacco or nicotine use (past 1-month)
• Ongoing exposure to abuse

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Tolan Park Medical Building — Detroit

Идентификаторы

NCT: NCT06297278 · IRB-23-01-5444 · R01MH132830

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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