Therapeutic Writing to Reduce Stress (RESeT)
Writing to Reduce Stress in Expectant Moms: The RESet Study
Purpose: The investigators hypothesize that exposure to chronic environmental stress is a risk factor for adverse pregnancy outcomes related to preterm birth and preeclampsia among high-risk pregnant women. Additionally, the investigators hypothesize that women can be screened for high levels of environmental stress through the perceived stress scale, and therapeutic writing can be used as a low-resource intervention to help decrease maternal perceived stress and inflammation - measured through analysis of maternal serum and placental samples.
Participants: Pregnant women at high risk for adverse pregnancy outcomes, including pre-eclampsia and preterm birth, enrolled in prenatal care at UNC will be recruited for participation
Procedures: Using results from the perceived stress scale, the investigators will identify women who screen positive for high environmental stress. Women meeting inclusion criteria will be contacted for possible participation at regularly scheduled prenatal visits. Women who are enrolled will be randomized to generalized writing prompts, therapeutic writing prompts, or no writing during their pregnancy to be administered at each prenatal visit. Maternal blood sample for biochemical markers of stress and gene expression will be obtained at the initial visit; a followup blood sample will be obtained later in pregnancy, and a small portion of the placenta saved at delivery. Delivery outcomes will be obtained through medical record review.
研究概览
详细说明
During pregnancy, women regularly interact with healthcare professionals, an often untapped resource and opportune time to optimize mental health, positively impacting outcomes. Cumulative psychosocial stress is a risk factor for several adverse obstetric outcomes including preterm birth (PTB), preeclampsia, fetal growth restriction, and postpartum depression.
The overarching hypothesis of this study is that pregnant women with high levels of stress can be identified through easily-implemented screening tools; importantly, the investigators propose that these women can be engaged in care via a cost-effective therapeutic writing intervention combined with the availability of expert pastoral and perinatal psychiatry resources.
Women will be enrolled early in pregnancy and followed prospectively. Some women (if randomized to a writing group) will complete a standardized writing prompt at several time points during gestation. The investigators will follow their outcomes prospectively.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- University of North Carolina Women's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Women will be prospectively recruited.
- Gestational age: All women presenting for prenatal care at 8.0 to 19.9 weeks' gestation through the UNC-Hospitals High Risk obstetrics clinic will be screened for high risk of an adverse pregnancy outcome (ex: preterm birth or pre-eclampsia) through review of their medical record.
- Singleton viable intrauterine pregnancy, with dating confirmed by ultrasound or plans for ultrasound to confirm dating prior to study enrollment
- No structural abnormalities or aneuploidy
- Ability to communicate in and provide consent in English
Women with at least ONE of the following high risk criteria:
a. Short cervix by endovaginal ultrasound, measuring <25mm b. Prior spontaneous preterm birth 16.0 - 33.9 weeks' gestation i. Documentation of the prior spontaneous preterm birth in the patient's medical records is desirable but is not required for eligibility.
ii. The previous preterm delivery cannot be an antepartum stillbirth but an intrapartum stillbirth (due to extreme prematurity) is allowable.
c. Chronic hypertension on medications d. History of pre-eclampsia requiring delivery <37 weeks' gestation, or history of severe pre-eclampsia delivering at any gestational age
OR
Women with at least TWO of the following moderate risk criteria:
- Prior preterm birth 34.0-36.9 weeks
- Chronic hypertension not requiring medications
- History of term pre-eclampsia
- Type II diabetes on insulin
- Obesity with a BMI >30
- Smoking during pregnancy
- Black race
- Maternal age <18 years old or >40 years old
- Nulliparous
- Uninsured, or medicaid insurance
- Women who meet at least one major or 2 minor inclusion criteria along with the other criteria above will then be screened for high levels of acute and chronic stress and trauma using the Perceived Stress questionnaire to determine final eligibility for the study
Exclusion Criteria:
- Persistent Illicit drug or alcohol abuse during current pregnancy >12 weeks. Use of tobacco and/or marijuana is not an exclusion. Methadone or suboxone use in an approved treatment program is not an exclusion.
- Prior preterm birth or preeclampsia was in a pregnancy complicated by fetal aneuploidy or major congenital fetal anomalies in the absence of another pregnancy meeting above inclusion criteria
Major congenital anomaly such as major structural deficit of the heart, lungs, or brain or aneuploidy
- Mild renal abnormalities, clubfoot, isolated cleft lip/palate, etc. in the fetus are not a reason for exclusion
- For a detailed list of major anomalies, see Table 3 - Major Fetal Anomalies / Congenital Malformations, below. Two or more minor anomalies observed together (see Table 2 - Minor Fetal Anomalies / Congenital Malformations) count as a "major" anomaly
- Isolated 'soft markers' for aneuploidy (such as choroid plexus cysts, echogenic bowel, etc.) are not a reason for exclusion
- If aneuploidy screening is performed, any aneuploidy screen positive test with a risk for aneuploidy greater than 1 in 25 without negative confirmatory definitive aneuploidy testing is reason for exclusion
- Spanish speaking women
- Women participating in other intervention-based studies
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Therapeutic Writing Prompts
Participants will be given writing prompts that discuss events that have been perceived as stressful in their lives and how they may or may not have cultivated resilience and coping strategies because of it.
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Participants will be given journals with writing prompts to be completed throughout their pregnancy.
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安慰剂比较:General Writing Prompts
Participants will be given writing prompts that discuss "neutral" topics unrelated to their life stress, resilience, or coping.
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Participants will be given journals with writing prompts to be completed throughout their pregnancy.
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无干预:No Writing
Participants will not be given writing prompts during their prenatal care.
They will be given blank journals that will NOT contain any instructions or writing prompts.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Percent Participation in Writing Activity
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
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The percentage of women who respond that they completed their assigned writing activity will be measured.
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through study completion, an average of 7 months per participant and 2 years for entire study
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Statistically significant improvement (reduction) in the Perceived Stress Scale Score
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
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Psychological instrument used to measure one's perception of stress (score range 0-40) will be assessed before and after the assigned writing activity.
Higher scores on the scale indicate a higher vulnerability for those with a high levels of perceived stress in their life.
Prior studies have noted the average score for a female age 30-44 is approximately 14.
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through study completion, an average of 7 months per participant and 2 years for entire study
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Proportion of women with adverse perinatal outcomes
大体时间:outcome will be ascertained at delivery
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We will define adverse pregnancy outcomes as a composite of preterm birth <37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
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outcome will be ascertained at delivery
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Change in pro-inflammatory biomarkers in maternal blood by randomization group
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
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All women participating in the study will have a blood draw.
Levels of stress biomarkers (e.g., interleukin-6) will be compared by randomization group
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through study completion, an average of 7 months per participant and 2 years for entire study
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Change in pro-inflammatory biomarkers in maternal blood by outcome
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
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All women participating in the study will have a blood draw.
Levels of stress biomarkers (e.g., interleukin-6) will be compared between women who develop the adverse perinatal outcome and those who do not
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through study completion, an average of 7 months per participant and 2 years for entire study
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Change in stress-related gene expression in maternal blood by randomization group
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
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All women participating in the study will have a blood draw.
We will evaluate gene expression of the CTRA gene panel (conserved transcriptional response to adversity gene panel) by randomization group
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through study completion, an average of 7 months per participant and 2 years for entire study
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Change in stress-related gene expression in maternal blood by outcome
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
|
All women participating in the study will have a blood draw.
We will evaluate gene expression of the CTRA gene panel (conserved transcriptional response to adversity gene panel) by whether or not the patient developed the adverse perinatal outcome
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through study completion, an average of 7 months per participant and 2 years for entire study
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Utilization of professional psychiatric care
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
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proportion of women who initiate or continue therapy with professional psychiatric care provider
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through study completion, an average of 7 months per participant and 2 years for entire study
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Stress related pathways gene expression - placental tissue - by randomization group
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
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After delivery, we will evaluate whether there are differences in the conserved transcriptional response to adversity gene panel (CTRA gene panel) by randomization groups
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through study completion, an average of 7 months per participant and 2 years for entire study
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Stress related pathways gene expression - placental tissue - by diagnosis of adverse perinatal outcome
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
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After delivery, we will evaluate whether there are differences in the conserved transcriptional response to adversity gene panel (CTRA gene panel) by whether or not the patient developed the adverse perinatal outcome
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through study completion, an average of 7 months per participant and 2 years for entire study
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Rate of preterm birth less than 37 weeks' gestation by randomization group
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
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we will individually evaluate the outcomes of preterm birth <37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
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through study completion, an average of 7 months per participant and 2 years for entire study
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Rate of diagnosis of intrauterine growth restriction, using sex-specific curves, by randomization group
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
|
we will individually evaluate the outcomes of preterm birth <37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
|
through study completion, an average of 7 months per participant and 2 years for entire study
|
Rate of diagnosis of preeclampsia by randomization group
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
|
we will individually evaluate the outcomes of preterm birth <37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
|
through study completion, an average of 7 months per participant and 2 years for entire study
|
Rate of diagnosis of placental abruption by randomization group
大体时间:through study completion, an average of 7 months per participant and 2 years for entire study
|
we will individually evaluate the outcomes of preterm birth <37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
|
through study completion, an average of 7 months per participant and 2 years for entire study
|
合作者和调查者
调查人员
- 首席研究员:Tracy A Manuck, MD、University of North Carolina
出版物和有用的链接
一般刊物
- McEwen BS. Stress, adaptation, and disease. Allostasis and allostatic load. Ann N Y Acad Sci. 1998 May 1;840:33-44. doi: 10.1111/j.1749-6632.1998.tb09546.x.
- Geronimus AT, Hicken M, Keene D, Bound J. "Weathering" and age patterns of allostatic load scores among blacks and whites in the United States. Am J Public Health. 2006 May;96(5):826-33. doi: 10.2105/AJPH.2004.060749. Epub 2005 Dec 27.
- Schulkin J, Gold PW, McEwen BS. Induction of corticotropin-releasing hormone gene expression by glucocorticoids: implication for understanding the states of fear and anxiety and allostatic load. Psychoneuroendocrinology. 1998 Apr;23(3):219-43. doi: 10.1016/s0306-4530(97)00099-1.
- Anding JE, Rohrle B, Grieshop M, Schucking B, Christiansen H. Couple comorbidity and correlates of postnatal depressive symptoms in mothers and fathers in the first two weeks following delivery. J Affect Disord. 2016 Jan 15;190:300-309. doi: 10.1016/j.jad.2015.10.033. Epub 2015 Oct 28.
- Edwards B, Galletly C, Semmler-Booth T, Dekker G. Does antenatal screening for psychosocial risk factors predict postnatal depression? A follow-up study of 154 women in Adelaide, South Australia. Aust N Z J Psychiatry. 2008 Jan;42(1):51-5. doi: 10.1080/00048670701739629.
- Juul SH, Hendrix C, Robinson B, Stowe ZN, Newport DJ, Brennan PA, Johnson KC. Maternal early-life trauma and affective parenting style: the mediating role of HPA-axis function. Arch Womens Ment Health. 2016 Feb;19(1):17-23. doi: 10.1007/s00737-015-0528-x. Epub 2015 May 9.
- Meltzer-Brody S, Boschloo L, Jones I, Sullivan PF, Penninx BW. The EPDS-Lifetime: assessment of lifetime prevalence and risk factors for perinatal depression in a large cohort of depressed women. Arch Womens Ment Health. 2013 Dec;16(6):465-73. doi: 10.1007/s00737-013-0372-9. Epub 2013 Aug 1.
- Oh W, Muzik M, McGinnis EW, Hamilton L, Menke RA, Rosenblum KL. Comorbid trajectories of postpartum depression and PTSD among mothers with childhood trauma history: Course, predictors, processes and child adjustment. J Affect Disord. 2016 Aug;200:133-41. doi: 10.1016/j.jad.2016.04.037. Epub 2016 Apr 20.
- McDonald SW, Kingston D, Bayrampour H, Dolan SM, Tough SC. Cumulative psychosocial stress, coping resources, and preterm birth. Arch Womens Ment Health. 2014 Dec;17(6):559-68. doi: 10.1007/s00737-014-0436-5. Epub 2014 Jun 20.
- Meshberg-Cohen S, Svikis D, McMahon TJ. Expressive writing as a therapeutic process for drug-dependent women. Subst Abus. 2014;35(1):80-8. doi: 10.1080/08897077.2013.805181.
- Blasio PD, Camisasca E, Caravita SC, Ionio C, Milani L, Valtolina GG. THE EFFECTS OF EXPRESSIVE WRITING ON POSTPARTUM DEPRESSION AND POSTTRAUMATIC STRESS SYMPTOMS. Psychol Rep. 2015 Dec;117(3):856-82. doi: 10.2466/02.13.PR0.117c29z3. Epub 2015 Nov 23.
- Smyth JM, Hockemeyer JR, Tulloch H. Expressive writing and post-traumatic stress disorder: effects on trauma symptoms, mood states, and cortisol reactivity. Br J Health Psychol. 2008 Feb;13(Pt 1):85-93. doi: 10.1348/135910707X250866.
- Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 18-2187
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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