Postpartum DepressionDREAMSSNCT02133963
Determining Relationships Among Maternity Stress & Sleep
An observational study of Postpartum Depression and Depression, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Psychosocial factors, including a previous history of depression, recent stressful life events, sleep disturbances during pregnancy, and depression and/or anxiety during pregnancy have been shown to be associated with an increased risk for the development of postpartum depression (PPD). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Depression
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2015
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Community sample of pregnant women
Who may be able to join
- nulliparous women in their 2nd trimester of a singleton pregnancy
- women between 18-45 years of age
- women with a past history of depression
- women with no past history of depression
Who cannot join
- under 18 years of age
- over 45 years of age
- pregnancy gestation > 22 weeks at study enrollment
- multiparity
- non-singleton pregnancy
- prior termination of pregnancy at >12 weeks gestation
Show all 23Show fewer
- prior loss of pregnancy >2 times at <12 weeks gestation
- prior history of stillbirth
- current substance use (alcohol and/or elicit drugs)
- current chronic steroid use
- current use of antidepressants, anti-anxiety medications, mood-stabilizers, psychotropic medications, progesterone treatment, or sleep medications
- current tobacco use
- diagnosed obstructive sleep apnea,
- diagnosed restless legs syndrome (RLS)
- certain cancers
- pre-gestational diabetes
- a body mass index (BMI) of > 40kg/m2 just prior to pregnancy
- chronic hypertension (documented or taking medication for hypertension)
- gestational hypertension
- preeclampsia
- current anemia
- current or past history of psychosis, schizoaffective disorder,or bipolar disorder
- current depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Dysregulation and Neuroendocrine Stress Reactivity: Towards a Biopsychosocial Model of Vulnerability to Postpartum Depression
Psychosocial factors, including a previous history of depression, recent stressful life events, sleep disturbances during pregnancy, and depression and/or anxiety during pregnancy have been shown to be associated with an increased risk for the development of postpartum depression (PPD). Biological mechanisms underlying the relationships among these psychosocial risk factors for PPD, and the development of PPD, remain unclear. However, evidence from non-perinatal populations suggest that dysregulation in stress-reactive neuroendocrine factors may play a role. The primary objectives of this study are: (1) to assess the feasibility of enrolling second trimester pregnant women, with or without depression histories, into a laboratory-based study protocol which includes a mild psychosocial stressor and the collection of venous blood for the measurement of stress-reactive adrenocorticotropic hormone (ACTH) and cortisol; (2) to assess the feasibility of retaining participants, for a brief postpartum phone interview, after completion of the second trimester assessments; and (3) to establish proof of concept for measuring group differences, between women with or without depression histories, in second trimester prenatal measures of neuroendocrine stress reactivity, depressive and anxious symptoms, recent stressful life events, and sleep quality.
- Conditions
- Postpartum Depression, Depression
- Keywords
- depression, postpartum depression, pregnancy, perinatal depression, sleep, life stress
- Medical subject headings
- Depression, Postpartum, Depression, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women with no history of depression | Non-Probability Sample of women with no history of depression | |
| women with a past depression history | Non-Probability Sample of women with a past history of depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the study protocol during the prenatal phase. Feasibility will be defined by the successful completion of enrollment and stress testing lab visits in 13 out of the 15 participants designed per group.
Measured: 20-22 weeks gestation through 22-24 weeks gestation
Secondary outcomes (7)
Feasibility with respect to the ability to retain participants / avoid attrition, which will be defined as having at least 90% of participants who completed the prenatal phase of the study, also complete one of the postpartum phone interviews.
Measured: Phone interviews will be administered at 8 weeks and 12 weeks postpartum.
The investigators will test for group differences, between women with or without depression histories, in stress reactivity of cortisol [calculated using area under the curve (AUC)] to a mild psychosocial stressor paradigm.
The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in stress reactivity of cortisol [calculated using area under the curve (AUC)] to a mild psychosocial stressor paradigm.
Measured: The mild psychosocial stressor paradigm will occur during the stress testing lab visit, which will be scheduled during gestational weeks 22-24
The investigators will test for group differences, between women with or without depression histories, in stress reactivity of adrenocorticotropic hormone ACTH [calculated using area under the curve (AUC)] to a mild psychosocial stressor paradigm.
The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in stress reactivity of adrenocorticotropic hormone (ACTH) [calculated using area under the curve (AUC)] to a mild psychosocial stressor paradigm.
Measured: The mild psychosocial stressor paradigm will occur during the stress testing lab visit, which will be scheduled during gestational weeks 22-24
The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in prenatal depressive symptoms using the Endinburgh Postnatal Depression Scale (EPDS).
Measured: The Endinburgh Postnatal Depression Scale (EPDS) will be administered during the enrollment visit, scheduled during gestational weeks 20-22.
The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in prenatal anxious symptoms using the Spielberger State-Trait Anxiety Inventory (STAI), trait version.
Measured: The trait version of the Spielberger State-Trait Anxiety Inventory (STAI) will be administered during the enrollment visit, scheduled during gestational weeks 20-22.
The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in recent stressful life events (last 6 months) using the Life Events Scale (LES).
Measured: The Life Events Scale (LES) will be administered during the enrollment visit, scheduled during gestational weeks 20-22.
The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in prenatal sleep quality (past 30 days) using the Pittsburgh Sleep Quality Index (PSQI).
Measured: The Pittsburgh Sleep Quality Index (PSQI) will be administered during the enrollment visit, scheduled during gestational weeks 20-22.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Principal investigator, Shannon Crowley, PhD, University of North Carolina, Chapel Hill
- Investigators
- Shannon K Crowley, PhD, Principal investigator, University of North Carolina, Chapel HillSusan S Girdler, PhD, Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133963
- Sponsor's protocol ID
- 13-3229
- Acronym
- DREAMSS
- Status last verified
- May 2015
- First submitted
- 6 May 2014
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Dysregulation and Neuroendocrine Stress Reactivity: Towards a Biopsychosocial Model of Vulnerability to Postpartum Depression
- ClinicalTrials.gov ID
- NCT02133963
- Acronym / sponsor ID
- DREAMSS / 13-3229
- Conditions
- Postpartum Depression, Depression
- Keywords
- depression, postpartum depression, pregnancy, perinatal depression, sleep, life stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 May 2014 (estimated)
- 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.
Psychosocial factors, including a previous history of depression, recent stressful life events, sleep disturbances during pregnancy, and depression and/or anxiety during pregnancy have been shown to be associated with an increased risk for the development of postpartum depression (PPD). Biological mechanisms underlying the relationships among these psychosocial risk factors for PPD, and the development of PPD, remain unclear. However, evidence from non-perinatal populations suggest that dysregulation in stress-reactive neuroendocrine factors may play a role. The primary objectives of this study are: (1) to assess the feasibility of enrolling second trimester pregnant women, with or without depression histories, into a laboratory-based study protocol which includes a mild psychosocial stressor and the collection of venous blood for the measurement of stress-reactive adrenocorticotropic hormone (ACTH) and cortisol; (2) to assess the feasibility of retaining participants, for a brief postpartum phone interview, after completion of the second trimester assessments; and (3) to establish proof of concept for measuring group differences, between women with or without depression histories, in second trimester prenatal measures of neuroendocrine stress reactivity, depressive and anxious symptoms, recent stressful life events, and sleep quality.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with no history of depression | – | –Non-Probability Sample of women with no history of depression |
| women with a past depression history | – | –Non-Probability Sample of women with a past history of depression |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample of pregnant women
Key inclusion criteria (4 listed)
- nulliparous women in their 2nd trimester of a singleton pregnancy
- women between 18-45 years of age
- women with a past history of depression
- women with no past history of depression
Key exclusion criteria (23 listed)
- under 18 years of age
- over 45 years of age
- pregnancy gestation > 22 weeks at study enrollment
- multiparity
- non-singleton pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of the study protocol during the prenatal phase. Feasibility will be defined by the successful completion of enrollment and stress testing lab visits in 13 out of the 15 participants designed per group.
Time frame: 20-22 weeks gestation through 22-24 weeks gestation
7 secondary outcomes
Feasibility with respect to the ability to retain participants / avoid attrition, which will be defined as having at least 90% of participants who completed the prenatal phase of the study, also complete one of the postpartum phone interviews.
Time frame: Phone interviews will be administered at 8 weeks and 12 weeks postpartum.
The investigators will test for group differences, between women with or without depression histories, in stress reactivity of cortisol [calculated using area under the curve (AUC)] to a mild psychosocial stressor paradigm.
Time frame: The mild psychosocial stressor paradigm will occur during the stress testing lab visit, which will be scheduled during gestational weeks 22-24
The investigators will test for group differences, between women with or without depression histories, in stress reactivity of adrenocorticotropic hormone ACTH [calculated using area under the curve (AUC)] to a mild psychosocial stressor paradigm.
Time frame: The mild psychosocial stressor paradigm will occur during the stress testing lab visit, which will be scheduled during gestational weeks 22-24
The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in prenatal depressive symptoms using the Endinburgh Postnatal Depression Scale (EPDS).
Time frame: The Endinburgh Postnatal Depression Scale (EPDS) will be administered during the enrollment visit, scheduled during gestational weeks 20-22.
The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in prenatal anxious symptoms using the Spielberger State-Trait Anxiety Inventory (STAI), trait version.
Time frame: The trait version of the Spielberger State-Trait Anxiety Inventory (STAI) will be administered during the enrollment visit, scheduled during gestational weeks 20-22.
The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in recent stressful life events (last 6 months) using the Life Events Scale (LES).
Time frame: The Life Events Scale (LES) will be administered during the enrollment visit, scheduled during gestational weeks 20-22.
The investigators will use a two-group t-test, or a Mann-Whitney-Wilcoxon test for non-normal distributions, to test for group differences in prenatal sleep quality (past 30 days) using the Pittsburgh Sleep Quality Index (PSQI).
Time frame: The Pittsburgh Sleep Quality Index (PSQI) will be administered during the enrollment visit, scheduled during gestational weeks 20-22.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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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.
Shannon K Crowley, PhD principal investigator
University of North Carolina, Chapel Hill
Susan S Girdler, PhD study chair
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression and Depression, 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 4 inclusion and 23 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: finished, as of the sponsor's last update on 19 May 2015. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of the study protocol during the prenatal phase. Feasibility will be defined by the successful completion of enrollment and stress testing lab visits in 13 out of the 15 participants designed per group. (time frame: 20-22 weeks gestation through 22-24 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2015.