Exercise and Therapeutic Learning Among Women With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Participant Skin Conductance Responding (SCR)
研究概览
简要总结
This study aims to test whether aerobic exercise performed after fear extinction learning improves the consolidation and subsequent recall of the learned safety memories (i.e., fear extinction memories) among adult women with PTSD related to interpersonal violence exposure, and whether this effect is mediated by the ability of exercise to increase acute levels of Brain-Derived Neurotrophic Factor (BDNF) and endocannabinoids (eCB). Participants can expect to be on study for up to 90 days, participating in 4 study stages: Day 1 of Assessments, Day 2 of Fear Learning, Day 3 of Fear Extinction (and activity), and Day 4 of Recall of Fear Extinction.
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
- 21 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
- •English speaking
- •Medically healthy
排除标准
- •Any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease and as assessed via the Physical Activity Readiness Questionnaire (PAR-Q), which probes into participants' history of heart conditions, chest pain, dizziness, loss of consciousness, bone/joint problems, and medication history). Participants would not be excluded if they report this condition being "controlled" or "addressed" through medication or lifestyle change, such as regular exercise.
- •Major medical disorders (such as cancer, AIDS)
- •Physical discomfort or difficulty with blood draws
- •Psychotic disorders
- •Intellectual disabilities
- •Developmental disorders
- •Active substance use disorders
- •Pregnancy
- •Due to safety concerns, participants with these conditions will be ineligible to participate:
- •Major medical disorders (e.g., HIV, cancer)
- •Daily cannabis use
- •History of light headedness or fainting during blood draws or physical activity
- •History of chest pain during physical activity
- •Abnormal EKG finding at intake visit screening, without follow-up clearance from their physician
- •Bone, joint, cardiac, pulmonary, metabolic, or other medical conditions that may be worsened by physical activity (e.g., Chronic Obstructive Pulmonary Disease (COPD), diabetes, hypertension) that is not currently addressed via medication or lifestyle change.
- •A positive pregnancy test
- •A self-reported history of loss of consciousness (greater than 30 minutes)
- •Physical disabilities that prohibit task performance (such as blindness or deafness)
- •Psychotic disorders (e.g., schizophrenia)
- •Any other condition that the investigator believes might put the participant at risk
结局指标
主要结局
Participant Skin Conductance Responding (SCR)
时间窗: up to Day 4
Aim 1 fear extinction analyses consists of a 2 (group: low-intensity exercise vs moderate-intensity exercise) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) mixed design focused on Day 4 fear responding (skin conductance responses). SCR data will be acquired on a BIOPAC MP150 Data Acquisition System (BIOPAC Systems, Inc.) with electrodes placed on participant's left hand. Participants will be instructed to select an intensity of a 7/10 on the subjective pain scale, which should be "uncomfortable, but not painful." Average intensity of participant skin conductance will be reported.
Group Differences in Serum Brain-Derived Neurotrophic Factor (BDNF)
时间窗: before and after 30 min exercise on Day 3
Aim 2 group differences in BDNF consists of a 2 (group: moderate-intensity vs low-intensity) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) x 2 (timepoint: pre condition vs post condition,) mixed design. The hypothesis is BDNF increases following exercise will separately mediate the relationship between aerobic exercise and enhanced fear extinction recall.
Group Differences in Serum Endocannabinoid (eCB) Content
时间窗: before and after 30 min exercise on Day 3
Aim 2 group differences in eCB consists of a 2 (group: moderate-intensity vs low-intensity) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) x 2 (timepoint: pre condition vs post condition,) mixed design. The hypothesis is eCBs increases following exercise will separately mediate the relationship between aerobic exercise and enhanced fear extinction recall.
次要结局
- Change in State-Trait Anxiety Inventory (STAI)(at each visit, up to Day 4)
- Change in Profile of Mood States (POMS) Questionnaire(at each visit, up to Day 4)
- Change in Positive and Negative Affect Scale (PANAS)(at each visit, up to Day 4)