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Therapeutic Writing to Reduce Stress (RESeT)

12 september 2022 uppdaterad av: University of North Carolina, Chapel Hill

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

15

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599
        • University of North Carolina Women's Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 50 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Participants will be given journals with writing prompts to be completed throughout their pregnancy.
Placebo-jämförare: General Writing Prompts
Participants will be given writing prompts that discuss "neutral" topics unrelated to their life stress, resilience, or coping.
Participants will be given journals with writing prompts to be completed throughout their pregnancy.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percent Participation in Writing Activity
Tidsram: through study completion, an average of 7 months per participant and 2 years for entire study
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
Tidsram: through study completion, an average of 7 months per participant and 2 years for entire study
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
Tidsram: outcome will be ascertained at delivery
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
Tidsram: 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. 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
Tidsram: 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. 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
Tidsram: 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 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
Tidsram: 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
through study completion, an average of 7 months per participant and 2 years for entire study

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Utilization of professional psychiatric care
Tidsram: through study completion, an average of 7 months per participant and 2 years for entire study
proportion of women who initiate or continue therapy with professional psychiatric care provider
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
Tidsram: through study completion, an average of 7 months per participant and 2 years for entire study
After delivery, we will evaluate whether there are differences in the conserved transcriptional response to adversity gene panel (CTRA gene panel) by randomization groups
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
Tidsram: through study completion, an average of 7 months per participant and 2 years for entire study
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
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
Tidsram: 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 intrauterine growth restriction, using sex-specific curves, by randomization group
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Tracy A Manuck, MD, University of North Carolina

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 oktober 2019

Primärt slutförande (Förväntat)

22 december 2024

Avslutad studie (Förväntat)

22 december 2024

Studieregistreringsdatum

Först inskickad

3 april 2019

Först inskickad som uppfyllde QC-kriterierna

4 april 2019

Första postat (Faktisk)

5 april 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 september 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 september 2022

Senast verifierad

1 september 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 18-2187

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

IPD-planbeskrivning

All information that is collected for this study will be stored in locked filing cabinets and/or offices and on the secure UNC server on the RedCap database. Participants will be assigned a unique study-id number for this study. Only the PI and Sponsor for the study will have access to the key linking this study id number to their personal clinical information and identifiers.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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