Depression, PostpartumPEARLSNCT03027037
Perinatal Emotion and Relationships Longitudinal Study
An observational study of Depression, Postpartum, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
This study, funded by the John Templeton Foundation, will examine birth and the early postpartum period (BEPP) as a transformative life experience that may shift women's experience of emotion in such ways as to a) support enhanced other-oriented emotions and b) underlie risk or resilience from psychopathology. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jan 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will include up to 200 pregnant adult women over the age of 18 across the United States. Two roughly equal groups of participants will be recruited: women with a history of major depressive disorder, currently in remission (MDD) and healthy controls with no current or lifetime history of mental illness (CTL).
Who may be able to join
- Over age 18
- Female
- Currently pregnant - approximately no more than 34 weeks gestational age
- Able to read and write in English fluently
- MDD Group: Meet DSM-IV/DSM-5 criteria for at least 1 past episode of Major Depressive Disorder
- MDD Group: DO NOT meet DSM-IV/DSM-5 criteria for any episodes of Major Depressive Disorder in past 2 months (currently in symptom remission)
Who cannot join
- Previous birth to a living child (i.e., this pregnancy is not their first child)
- Imminently suicidal or homicidal
- History of severe head trauma, stroke, neurological disease
- History of brain tumors or surgery
- Severe medical illness (e.g., autoimmune disorder, blindness, cardiovascular disease, HIV/AIDS)
- Endocrine disorders (e.g., Cushing's disease, thyroid disorder)
Show all 10Show fewer
- Alcohol/substance abuse or dependence within the past six months
- Current psychotic episode (impairing ability to consent, participate, or keep patient and experimenter safe)
- Inability to follow study procedures
- CTL Group: Current or lifetime Axis I disorder (i.e., anxiety disorders, major depression, mania/hypomania, dysthymia, schizophrenia, schizoaffective disorder, substance abuse/dependence, eating disorders, hypochondriasis, pain disorder, or adjustment disorders)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
This study, funded by the John Templeton Foundation, will examine birth and the early postpartum period (BEPP) as a transformative life experience that may shift women's experience of emotion in such ways as to a) support enhanced other-oriented emotions and b) underlie risk or resilience from psychopathology.
Read the detailed description
Specifically, the study will investigate the extent to which women can accurately have knowledge about and predict changes in self- and other-oriented emotion processes associated with BEPP. The investigators will also characterize the extent to which BEPP changes self- and other-oriented emotion processes and self- and other-oriented social behaviors. Further, the investigators will identify distinct trajectories of change in cognitive processes and self- and other-oriented emotion processes related to BEPP, and examine how those trajectories are associated with psychological adjustment (e.g., risk and relapse of psychopathology). Finally, the investigators will identify which particular features of BEPP are related to distinct patterns of change in self- and other-oriented emotion processes.
- Conditions
- Depression, Postpartum
- Medical subject headings
- Depression, Postpartum
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 |
|---|---|---|
| Remitted Major Depression Group | Women in this group will have experienced at least one episode of major depression in their lifetime, but no episodes in the two months prior to study enrollment. | |
| Control Group | Women in this group will never have experienced any Diagnostic and Statistical Manual of Mental Disorders, 5th Edition Axis I psychological disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of mood episodes and anxiety disorders
Assessed via interview
Measured: Throughout study (pregnancy to 6 months postpartum)
Mood and anxiety symptoms
Assessed via questionnaires
Measured: Throughout study (pregnancy to 6 months postpartum)
Emotion reactivity and regulation
Assessed via questionnaires, experimental tasks, and physiological measurement
Measured: Throughout study (pregnancy to 6 months postpartum)
Empathic accuracy
Assessed via experimental tasks
Measured: Throughout study (pregnancy to 6 months postpartum)
Prosocial behavior
Assessed via questionnaires and experimental tasks
Measured: Throughout study (pregnancy to 6 months postpartum)
Well-being and social support
Assessed via questionnaires
Measured: Throughout study (pregnancy to 6 months postpartum)
Parenting sensitivity, efficacy, stress, bond with infant
Assessed via questionnaires and behavioral observation
Measured: Throughout study (pregnancy to 6 months postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startNov 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- John Templeton Foundation, Emory University, University of Michigan, Columbia University, Queen's University
- Responsible party
- Principal investigator, Sona Dimidjian, University of Colorado, Boulder
- Investigators
- Sona Dimidjian, PhD, Principal investigator, University of Colorado, BoulderJune Gruber, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027037
- Sponsor's protocol ID
- 49683
- Acronym
- PEARLS
- Status last verified
- Mar 2020
- First submitted
- 17 Jan 2017
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Emotion and Relationships Longitudinal Study
- ClinicalTrials.gov ID
- NCT03027037
- Acronym / sponsor ID
- PEARLS / 49683
- Conditions
- Depression, Postpartum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- John Templeton Foundation, Emory University, University of Michigan, Columbia University, Queen's University
- Study start
- Nov 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 20 Jan 2017 (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.
This study, funded by the John Templeton Foundation, will examine birth and the early postpartum period (BEPP) as a transformative life experience that may shift women's experience of emotion in such ways as to a) support enhanced other-oriented emotions and b) underlie risk or resilience from psychopathology.
Detailed description
Specifically, the study will investigate the extent to which women can accurately have knowledge about and predict changes in self- and other-oriented emotion processes associated with BEPP. The investigators will also characterize the extent to which BEPP changes self- and other-oriented emotion processes and self- and other-oriented social behaviors. Further, the investigators will identify distinct trajectories of change in cognitive processes and self- and other-oriented emotion processes related to BEPP, and examine how those trajectories are associated with psychological adjustment (e.g., risk and relapse of psychopathology). Finally, the investigators will identify which particular features of BEPP are related to distinct patterns of change in self- and other-oriented emotion processes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remitted Major Depression Group | – | –Women in this group will have experienced at least one episode of major depression in their lifetime, but no episodes in the two months prior to study enrollment. |
| Control Group | – | –Women in this group will never have experienced any Diagnostic and Statistical Manual of Mental Disorders, 5th Edition Axis I psychological disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include up to 200 pregnant adult women over the age of 18 across the United States. Two roughly equal groups of participants will be recruited: women with a history of major depressive disorder, currently in remission (MDD) and healthy controls with no current or lifetime history of mental illness (CTL).
Key inclusion criteria (6 listed)
- Over age 18
- Female
- Currently pregnant - approximately no more than 34 weeks gestational age
- Able to read and write in English fluently
- MDD Group: Meet DSM-IV/DSM-5 criteria for at least 1 past episode of Major Depressive Disorder
Key exclusion criteria (10 listed)
- Previous birth to a living child (i.e., this pregnancy is not their first child)
- Imminently suicidal or homicidal
- History of severe head trauma, stroke, neurological disease
- History of brain tumors or surgery
- Severe medical illness (e.g., autoimmune disorder, blindness, cardiovascular disease, HIV/AIDS)
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
Occurrence of mood episodes and anxiety disorders
Time frame: Throughout study (pregnancy to 6 months postpartum)
Assessed via interview
Mood and anxiety symptoms
Time frame: Throughout study (pregnancy to 6 months postpartum)
Assessed via questionnaires
Emotion reactivity and regulation
Time frame: Throughout study (pregnancy to 6 months postpartum)
Assessed via questionnaires, experimental tasks, and physiological measurement
Empathic accuracy
Time frame: Throughout study (pregnancy to 6 months postpartum)
Assessed via experimental tasks
Prosocial behavior
Time frame: Throughout study (pregnancy to 6 months postpartum)
Assessed via questionnaires and experimental tasks
Well-being and social support
Time frame: Throughout study (pregnancy to 6 months postpartum)
Assessed via questionnaires
Parenting sensitivity, efficacy, stress, bond with infant
Time frame: Throughout study (pregnancy to 6 months postpartum)
Assessed via questionnaires and behavioral observation
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 31 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Sona Dimidjian, PhD principal investigator
University of Colorado, Boulder
June Gruber, PhD principal investigator
University of Colorado, Boulder
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 Depression, Postpartum, run by University of Colorado, Boulder 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 6 inclusion and 10 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 31 Mar 2020. 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?
Occurrence of mood episodes and anxiety disorders (time frame: Throughout study (pregnancy to 6 months postpartum)). 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?
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 31 Mar 2020.