Pregnancy ComplicationsRESeTNCT03904979
Therapeutic Writing to Reduce Stress
A study testing Writing exercises in people with Pregnancy Complications and Stress, Physiological, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Stress, Physiological, High Risk Pregnancy
- What is being tested?
- Writing exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2019to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 22Show fewer
- 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.
- The previous preterm delivery cannot be an antepartum stillbirth but an intrapartum stillbirth (due to extreme prematurity) is allowable.
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Women's Hospital
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
Read the 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.
- Being tested
- Writing exercises
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Writing exercisesOther
Participants will be given journals with writing prompts to be completed throughout their pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Participation in Writing Activity
The percentage of women who respond that they completed their assigned writing activity will be measured.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 7 months per participant and 2 years for entire study
Secondary outcomes (7)
Utilization of professional psychiatric care
proportion of women who initiate or continue therapy with professional psychiatric care provider
Measured: 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
After delivery, we will evaluate whether there are differences in the conserved transcriptional response to adversity gene panel (CTRA gene panel) by randomization groups
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: through study completion, an average of 7 months per participant and 2 years for entire study
Rate of diagnosis of preeclampsia by randomization group
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
Measured: 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
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
Measured: through study completion, an average of 7 months per participant and 2 years for entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start22 Oct 2019
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Why it stopped: Unable to continue due to loss of staff.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracy A Manuck, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904979
- Sponsor's protocol ID
- 18-2187
- Acronym
- RESeT
- Status last verified
- Aug 2024
- First submitted
- 3 Apr 2019
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 9629234Geronimus 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.
PubMed 16380565Schulkin 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.
PubMed 9695128Anding 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.
PubMed 26546770Edwards 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.
PubMed 18058444Juul 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.
PubMed 25956587Meltzer-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.
PubMed 23904137Oh 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.
PubMed 27131504McDonald 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.
PubMed 24948100Meshberg-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.
PubMed 24588298Blasio 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.
PubMed 26595300Smyth 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.
PubMed 18230238Carver 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.
PubMed 2926629
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Writing to Reduce Stress in Expectant Moms: The RESet Study
- ClinicalTrials.gov ID
- NCT03904979
- Acronym / sponsor ID
- RESeT / 18-2187
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to continue due to loss of staff.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Writing Prompts | Experimental | Other: Writing exercisesParticipants 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. |
| General Writing Prompts | Placebo comparator | Other: Writing exercisesParticipants will be given writing prompts that discuss "neutral" topics unrelated to their life stress, resilience, or coping. |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Women will be prospectively recruited.
- OR
Key exclusion criteria (9 listed)
- 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
- Spanish speaking women
- Women participating in other intervention-based studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Writing exercisesParticipants will be given journals with writing prompts to be completed throughout their pregnancy. | Other | General Writing Prompts, Therapeutic Writing Prompts |
Primary outcome
Percent Participation in Writing Activity
Time frame: 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.
Statistically significant improvement (reduction) in the Perceived Stress Scale Score
Time frame: 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.
Proportion of women with adverse perinatal outcomes
Time frame: 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
Change in pro-inflammatory biomarkers in maternal blood by randomization group
Time frame: 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
Change in pro-inflammatory biomarkers in maternal blood by outcome
Time frame: 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
Change in stress-related gene expression in maternal blood by randomization group
Time frame: 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
Change in stress-related gene expression in maternal blood by outcome
Time frame: 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
7 secondary outcomes
Utilization of professional psychiatric care
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Rate of diagnosis of preeclampsia by randomization group
Time frame: 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
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Results and safety
The study was stopped early (reason given: Unable to continue due to loss of staff.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 9629234McEwen 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.
- Background: PubMed 16380565Geronimus 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.
- Background: PubMed 9695128Schulkin 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.
- Background: PubMed 26546770Anding 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.
- Background: PubMed 18058444Edwards 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.
- Background: PubMed 25956587Juul 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.
- Background: PubMed 23904137Meltzer-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.
- Background: PubMed 27131504Oh 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.
- Background: PubMed 24948100McDonald 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.
- Background: PubMed 24588298Meshberg-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.
- Background: PubMed 26595300Blasio 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.
- Background: PubMed 18230238Smyth 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy A Manuck, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Writing exercises in people with Pregnancy Complications and Stress, Physiological, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to continue due to loss of staff.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Participation in Writing Activity (time frame: through study completion, an average of 7 months per participant and 2 years for entire study). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03904979, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.