Therapeutic Writing to Reduce Stress

NCT03904979 | Terminated

• 1 other identifier: 18-2187
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complications; Stress, Physiological; High Risk Pregnancy

Outcome Measures

Primary Outcomes (7)

• Percent Participation in Writing Activity

  The percentage of women who respond that they completed their assigned writing activity will be measured.

  through study completion, an average of 7 months per participant and 2 years for entire study

• Statistically significant improvement (reduction) in the Perceived Stress Scale Score

  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.

  through study completion, an average of 7 months per participant and 2 years for entire study

• Proportion of women with adverse perinatal outcomes

  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

  outcome will be ascertained at delivery

• Change in pro-inflammatory biomarkers in maternal blood by randomization group

  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

  through study completion, an average of 7 months per participant and 2 years for entire study

• Change in pro-inflammatory biomarkers in maternal blood by outcome

  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

  through study completion, an average of 7 months per participant and 2 years for entire study

• Change in stress-related gene expression in maternal blood by randomization group

  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

  through study completion, an average of 7 months per participant and 2 years for entire study

• Change in stress-related gene expression in maternal blood by outcome

  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

  through study completion, an average of 7 months per participant and 2 years for entire study

Secondary Outcomes (7)

• Utilization of professional psychiatric care

  through study completion, an average of 7 months per participant and 2 years for entire study

• Stress related pathways gene expression - placental tissue - by randomization group

  through study completion, an average of 7 months per participant and 2 years for entire study

• Stress related pathways gene expression - placental tissue - by diagnosis of adverse perinatal outcome

  through study completion, an average of 7 months per participant and 2 years for entire study

• Rate of preterm birth less than 37 weeks' gestation by randomization group

  through study completion, an average of 7 months per participant and 2 years for entire study

• Rate of diagnosis of intrauterine growth restriction, using sex-specific curves, by randomization group

  through study completion, an average of 7 months per participant and 2 years for entire study

Study Arms (3)

Therapeutic Writing Prompts

EXPERIMENTAL

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.

Other: Writing exercises

General Writing Prompts

PLACEBO COMPARATOR

Participants will be given writing prompts that discuss "neutral" topics unrelated to their life stress, resilience, or coping.

Other: Writing exercises

No Writing

NO INTERVENTION

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.

Interventions

Writing exercises OTHER

Participants will be given journals with writing prompts to be completed throughout their pregnancy.

General Writing Prompts; Therapeutic Writing Prompts

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• Major congenital anomaly such as major structural deficit of the heart, lungs, or brain or aneuploidy
• 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
• Spanish speaking women
• Women participating in other intervention-based studies

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Women's Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (13)

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• 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.

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• 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.

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• 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.

  PMID: 25956587 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

  PMID: 24588298 BACKGROUND

• 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.

  PMID: 26595300 BACKGROUND

• 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.

  PMID: 18230238 BACKGROUND

• 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.

  PMID: 2926629 BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Tracy A Manuck, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will have identical journals regardless of the intervention or control group status, and providers will be blinded to the writing prompts that participants are given. Women who are randomized to 'no writing' will be provided a blank journal without any instruction. this will be considered a 'gift' for study participation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: October 22, 2019
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: February 10, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)