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临床试验/NCT05425290
NCT05425290已完成不适用

Emotion Regulation Training to Reduce Cardiovascular Disease Risk Among Depressed Young Adults in Southern Mississippi: A Single-Session Design

University of Southern Mississippi2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in Diastolic Blood Pressure

研究概览

简要总结

The proposed study will investigate the utility of a single-session emotion regulation training to reduce CVD risk among young adults diagnosed with MDD living in Southern MS. Using an single-arm, non-randomized design, young adults aged 18-29 will undergo a single-session emotion regulation skills training. Before and immediately after the skills training session, participants will supply several biological metrics tied to CVD risk: resting HRV, inflammation (measured via c-reactive protein [CRP]), and blood pressure. Participants will provide the same biological metrics at a one-week follow-up visit to assess short-term sustained gains following the single-session intervention and complete a 7-day ecological momentary assessment (EMA) of their daily emotion regulation skills use and depressive symptoms between these two visits.

详细描述

Cardiovascular disease (CVD) is a leading cause of death in Mississippi, accounting for over a third of deaths within the state. Mississippians face numerous health disparities that enhance disease risk throughout our community. In addition to behavioral factors, several notable biological markers enhance risk for CVD including low resting heart rate variability (HRV), high blood pressure, and inflammation. In Mississippi, an estimated 20.9% of adults meet criteria for depression. Adults experiencing depressive disorders experience high rates of emotion dysregulation, and psychological interventions that include emotion regulation training components are highly efficacious in reducing psychological and physical symptoms associated with depression. Depression, particularly major depressive disorder, is routinely linked with enhanced CVD risk. Understanding and intervening on the relationship between CVD risk factors and depression in young adulthood offers potential to prevent exacerbation of risk later in life. This pilot study will investigate the utility of a single-session emotion regulation training to reduce CVD risk among young adults living in Southern Mississippi who are diagnosed with major depressive disorder (MDD). The study aims are to: 1) examine whether the single-session emotion regulation training promotes changes in biological risk factors for cardiovascular disease immediately following the training and at a 1-week follow-up visit; 2) to assess whether the single-session emotion regulation training reduces depressive symptoms among research subjects; and 3) to test whether use of emotion regulation skills learned during the training in the week following the intervention session promotes greater changes in cardiovascular disease risk factors. Using a lab-based experimental intervention design, young adults will undergo a single-session emotion regulation skills training. Before and after the skills training session, research subjects will supply several physiological metrics tied to CVD risk: resting HRV, c-reactive protein (CRP) levels, and blood pressure. Subjects will provide the same biological metrics at a one-week follow-up visit to assess short-term sustained gains following the single-session intervention. Results from this study offer potential to reduce emotion regulation difficulties associated with major depression, reduce CVD risk factors among young adults in Mississippi, and advance our knowledge of how psychological interventions can improve both psychological and physical risk factors for chronic health conditions among young adults, potentially buffering depression's long-term health impact.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women ages 18-29
  • Able to speak and read English
  • Outpatient at the time of participation
  • Able to provide informed consent
  • Stable medications for 30 days or more
  • Appropriate diagnoses:
  • Meets diagnostic criteria for current major depressive disorder

排除标准

  • Not fluent in English
  • Not able to provide informed consent
  • Active suicidal ideation
  • Presence of autoimmune and/or inflammatory diseases (e.g., rheumatoid arthritis, ulcerative colitis)
  • Ongoing use of steroids (if use of steroids is temporary, individuals are eligible to participate 30 days after termination)
  • Medication change in the past 30 days (individuals are eligible to participate 30 days after a medication change and may take advantage of delayed scheduling)
  • Meets diagnostic criteria for a schizophrenia-spectrum disorder, substance use disorder, and/or bipolar disorder
  • Presence of a cardiovascular disease (e.g., hypertension) or prescribed cardiovascular medications (e.g., beta blockers, blood pressure medication)

结局指标

主要结局

Change in Diastolic Blood Pressure

时间窗: Change from prior to the single-session emotion regulation training to immediately after and 1-week after

Diastolic blood pressure will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit

Change in Systolic Blood Pressure

时间窗: Change from prior to the single-session emotion regulation training to immediately after and 1-week after

Systolic blood pressure will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit

Change in Resting Heart Rate Variability (HRV)

时间窗: Change from prior to the single-session emotion regulation training to immediately after and 1-week after

Resting heart rate variability (HRV) will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit

Change in C-reactive protein (CRP)

时间窗: Change from prior to the single-session emotion regulation training to immediately after and 1-week after

C-reactive protein (CRP) will be measured prior to the training, immediately afterwards, and during the 1-week follow-up visit

Change in Center for Epidemiological Studies - Depression Scale (CESD)

时间窗: Change from prior to the single-session emotion regulation training to immediately after and 1-week after

Depressive symptoms will be assessed using the CESD prior to the training, immediately afterwards, and at the 1-week follow-up visit. Depressive symptoms will also be assessed during the EMA assessment period.

次要结局

  • Change in Emotion Regulation Questionnaire, Reappraisal subscale (ERQ-R)(Change from prior to the single-session emotion regulation training to immediately after and 1-week after)
  • Change in Experiences Questionnaire - Decentering (EQ-D)(Change from prior to the single-session emotion regulation training to immediately after and 1-week after)
  • Change in Difficulties with Emotion Regulation Scale (DERS)(Change from prior to the single-session emotion regulation training to immediately after and 1-week after)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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