Depression, Postpartum Clinical Trial
— PEARLSOfficial title:
Perinatal Emotion and Relationships Longitudinal Study
NCT number | NCT03027037 |
Other study ID # | 49683 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | January 2018 |
Verified date | March 2020 |
Source | University of Colorado, Boulder |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | January 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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) - 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Boulder | Boulder | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Boulder | Columbia University, Emory University, John Templeton Foundation, Queen's University, University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of mood episodes and anxiety disorders | Assessed via interview | Throughout study (pregnancy to 6 months postpartum) | |
Primary | Mood and anxiety symptoms | Assessed via questionnaires | Throughout study (pregnancy to 6 months postpartum) | |
Primary | Emotion reactivity and regulation | Assessed via questionnaires, experimental tasks, and physiological measurement | Throughout study (pregnancy to 6 months postpartum) | |
Primary | Empathic accuracy | Assessed via experimental tasks | Throughout study (pregnancy to 6 months postpartum) | |
Primary | Prosocial behavior | Assessed via questionnaires and experimental tasks | Throughout study (pregnancy to 6 months postpartum) | |
Primary | Well-being and social support | Assessed via questionnaires | Throughout study (pregnancy to 6 months postpartum) | |
Primary | Parenting sensitivity, efficacy, stress, bond with infant | Assessed via questionnaires and behavioral observation | Throughout study (pregnancy to 6 months postpartum) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04012580 -
Examining the Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy in New Mothers Experiencing Anxiety and Depression
|
N/A | |
Recruiting |
NCT05813782 -
The Effect of Baby Massage on Postpartum Depression and Maternal Attachment
|
N/A | |
Recruiting |
NCT05907213 -
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery
|
Phase 1 | |
Completed |
NCT00602732 -
Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse
|
Phase 1 | |
Completed |
NCT00053651 -
Prevention of Postpartum Depression in Low-Income Women
|
Phase 1 | |
Completed |
NCT00043602 -
Clinician Managed Interpersonal Psychotherapy
|
Phase 0 | |
Completed |
NCT04169334 -
Look - Your Baby is Talking to You.
|
N/A | |
Completed |
NCT03573713 -
Decreasing Stunting by Reducing Maternal Depression in Uganda: A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes
|
N/A | |
Completed |
NCT04043533 -
The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women
|
N/A | |
Completed |
NCT06070168 -
Determining the Effect of Telephone Counseling Service Provided to Primiparous Mothers on Postpartum Depression
|
N/A | |
Recruiting |
NCT05050266 -
Enhancing Mental and Physical Health of Women Veterans
|
N/A | |
Completed |
NCT02505984 -
Preventing Postpartum Depression With Intranasal Oxytocin
|
Phase 2 | |
Recruiting |
NCT00251342 -
Outcome of Postnatal Depression Screening Using Edinburgh Postnatal Depression Scale
|
Phase 2/Phase 3 | |
Completed |
NCT02526433 -
The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)
|
N/A | |
Completed |
NCT02526407 -
The Impact of Creative Interventions on Symptoms of Postnatal Depression
|
N/A | |
Completed |
NCT03574766 -
Meditation for NICU Moms
|
N/A | |
Completed |
NCT03646539 -
RCT of Automated Conversational Agent vs. Treatment as Usual for the Management of Perinatal Mood
|
N/A | |
Active, not recruiting |
NCT05110456 -
To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk
|
N/A | |
Recruiting |
NCT04154423 -
Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study
|
N/A | |
Not yet recruiting |
NCT04093791 -
MAMA NO STRESS Project. The Effects of the "HAPPY MAMA" Intervention
|
N/A |