Determining Relationships Among Maternity Stress & Sleep

Depression Clinical Trial

— DREAMSS  

Official title:

Sleep Dysregulation and Neuroendocrine Stress Reactivity: Towards a Biopsychosocial Model of Vulnerability to Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133963
• Other study ID #: 13-3229
• Status: Completed
• Phase: N/A
• First received: May 6, 2014
• Last updated: May 15, 2015
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		20-22 weeks gestation through 22-24 weeks gestation	No
Secondary	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.		Phone interviews will be administered at 8 weeks and 12 weeks postpartum.	No
Secondary	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.	The mild psychosocial stressor paradigm will occur during the stress testing lab visit, which will be scheduled during gestational weeks 22-24	No
Secondary	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.	The mild psychosocial stressor paradigm will occur during the stress testing lab visit, which will be scheduled during gestational weeks 22-24	No
Secondary	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).		The Endinburgh Postnatal Depression Scale (EPDS) will be administered during the enrollment visit, scheduled during gestational weeks 20-22.	No
Secondary	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.		The trait version of the Spielberger State-Trait Anxiety Inventory (STAI) will be administered during the enrollment visit, scheduled during gestational weeks 20-22.	No
Secondary	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).		The Life Events Scale (LES) will be administered during the enrollment visit, scheduled during gestational weeks 20-22.	No
Secondary	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).		The Pittsburgh Sleep Quality Index (PSQI) will be administered during the enrollment visit, scheduled during gestational weeks 20-22.	No