Clinical trial NCT03904979: Therapeutic Writing to Reduce Stress
Official title: Writing to Reduce Stress in Expectant Moms: The RESet Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy Complications
Stress, Physiological
High Risk Pregnancy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women will be prospectively recruited.

  1. 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.
  2. Singleton viable intrauterine pregnancy, with dating confirmed by ultrasound or plans for ultrasound to confirm dating prior to study enrollment
  3. No structural abnormalities or aneuploidy
  4. Ability to communicate in and provide consent in English
  5. 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
  6. Women with at least TWO of the following moderate risk criteria:

     1. Prior preterm birth 34.0-36.9 weeks
     2. Chronic hypertension not requiring medications
     3. History of term pre-eclampsia
     4. Type II diabetes on insulin
     5. Obesity with a BMI \>30
     6. Smoking during pregnancy
     7. Black race
     8. Maternal age \<18 years old or \>40 years old
     9. Nulliparous
     10. Uninsured, or medicaid insurance
  7. 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:

1. 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.
2. 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
3. Major congenital anomaly such as major structural deficit of the heart, lungs, or brain or aneuploidy

   1. Mild renal abnormalities, clubfoot, isolated cleft lip/palate, etc. in the fetus are not a reason for exclusion
   2. 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
   3. Isolated 'soft markers' for aneuploidy (such as choroid plexus cysts, echogenic bowel, etc.) are not a reason for exclusion
   4. 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
4. Spanish speaking women
5. Women participating in other intervention-based studies

Primary outcomes:
measure: Percent Participation in Writing Activity
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
measure: Statistically significant improvement (reduction) in the Perceived Stress Scale Score
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
measure: Proportion of women with adverse perinatal outcomes
timeFrame: outcome will be ascertained at delivery
measure: Change in pro-inflammatory biomarkers in maternal blood by randomization group
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
measure: Change in pro-inflammatory biomarkers in maternal blood by outcome
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
measure: Change in stress-related gene expression in maternal blood by randomization group
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
measure: Change in stress-related gene expression in maternal blood by outcome
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
Secondary outcomes:
measure: Utilization of professional psychiatric care
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
measure: Stress related pathways gene expression - placental tissue - by randomization group
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
measure: Stress related pathways gene expression - placental tissue - by diagnosis of adverse perinatal outcome
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
measure: Rate of preterm birth less than 37 weeks' gestation by randomization group
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
measure: Rate of diagnosis of intrauterine growth restriction, using sex-specific curves, by randomization group
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
measure: Rate of diagnosis of preeclampsia by randomization group
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
measure: Rate of diagnosis of placental abruption by randomization group
timeFrame: through study completion, an average of 7 months per participant and 2 years for entire study
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Women's Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Tracy A Manuck, MD
role: PRINCIPAL_INVESTIGATOR
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