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Trial record 34 of 45 for:    Postpartum Depression AND PPD | "Depression" AND "Depression"

Determining Relationships Among Maternity Stress & Sleep (DREAMSS)

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ClinicalTrials.gov Identifier: NCT02133963
Recruitment Status : Completed
First Posted : May 8, 2014
Last Update Posted : May 19, 2015
Sponsor:
Collaborator:
North Carolina Translational and Clinical Sciences Institute
Information provided by (Responsible Party):
Shannon Crowley, PhD, University of North Carolina, Chapel Hill

Brief 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.

Condition or disease
Postpartum Depression Depression

Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Sleep Dysregulation and Neuroendocrine Stress Reactivity: Towards a Biopsychosocial Model of Vulnerability to Postpartum Depression
Study Start Date : May 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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 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.

  3. 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 stress reactivity of adrenocorticotropic hormone (ACTH) [calculated using area under the curve (AUC)] to a mild psychosocial stressor paradigm.

  4. 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. ]
  5. 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. ]
  6. 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. ]
  7. 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. ]

Biospecimen Retention:   Samples Without DNA
Serum, Plasma, Adrenocorticotropic hormone (ACTH), Cortisol


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample of pregnant women
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133963


Locations
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
North Carolina Translational and Clinical Sciences Institute
Investigators
Principal Investigator: Shannon K Crowley, PhD University of North Carolina, Chapel Hill
Study Chair: Susan S Girdler, PhD University of North Carolina, Chapel Hill

Responsible Party: Shannon Crowley, PhD, Postdoctoral Fellow, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02133963     History of Changes
Other Study ID Numbers: 13-3229
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015

Keywords provided by Shannon Crowley, PhD, University of North Carolina, Chapel Hill:
depression
postpartum depression
pregnancy
perinatal depression
sleep
life stress

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications