- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05503056
Art Therapy in Obstetric Patients
The Utilization of Art Therapy During Pregnancy to Reduce the Incidence of Postpartum Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this research study is to assess whether alternative mental health interventions positively impacts maternal-infant bonding and postpartum depression rates in women. Postpartum depression continues to be a prevalent concern for mothers and families in the United States, with current estimates demonstrating 10-20% of women being diagnosed within one year of birth. The risks of developing postpartum depression are not well known, with maternal anxiety and stress during pregnancy being one of the proposed predisposing factors. Women with high-risk pregnancies are particularly susceptible to higher levels of stress and depression, during their pregnancy thus leaving them at great risk for postnatal depression. Given this association, finding ways to alleviate stressors is important.
Music therapy is a known intervention linked with improved outcomes in women undergoing procedural interventions, including labor and delivery. Art therapy is also associated with improved outcomes, though outside of obstetrics. In elderly women with depression and those with breast cancer diagnoses, visual art therapy has been shown to be superior to other non-medicinal interventions in improving mood. Current data is both qualitative as well as quantitative, demonstrating positive impacts on patients.
While evidence exists to support the utilization of these alternative forms of therapy, they have not been adequately applied to pregnant and postpartum women outside of music therapy. With the understanding that other art forms are tied with improvement in anxiety, depression, and quality of life, the implementation in this special patient population is paramount. Investigating how a relatively benign intervention can possibly promote improvement in maternal mental health, thus allowing for better mother-baby bonding in the first year of life, is key in finding ways to support the growth and development of healthy families.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fatimah Fahimuddin, MD
- Phone Number: 202-877-3067
- Email: fatimah.z.fahimuddin@medstar.net
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Washington Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants will have to be eighteen years of age or older
- in the second trimester of pregnancy at time of recruitment
- speak and read English as their primary language
- have access to a reliable internet/wifi connection to participate in therapy sessions
- plan to deliver at Washington Hospital Center
Exclusion Criteria:
- Women who do not meet those criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Engage in six art therapy sessions
|
six sessions of art therapy with licensed therapists
|
Placebo Comparator: Control
Engage in usual activities
|
no intervention to this group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in Edinburgh Postnatal Depression Scale scores
Time Frame: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
|
raw score on scale
|
start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
|
change in maternal-infant bonding scores
Time Frame: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
|
raw score on scale
|
start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
|
utilization of behavioral health/psychology/psychiatry services during pregnancy and postpartum
Time Frame: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
|
chart review to see if patients utilized services "yes" vs. "no"
|
start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
|
use of psychiatry medications during and after pregnancy
Time Frame: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
|
chart review to see if patients utilized services "yes" vs. "no"
|
start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
obstetrical complications (postpartum hemorrhage, OASIS, ICU admission)
Time Frame: up to 3 months postpartum
|
chart review
|
up to 3 months postpartum
|
gestational age at time of delivery
Time Frame: delivery
|
chart review
|
delivery
|
mode of delivery
Time Frame: delivery
|
chart review
|
delivery
|
reason for delivery (iatrogenic vs spontaneous)
Time Frame: delivery
|
chart review
|
delivery
|
birth weight
Time Frame: delivery
|
chart review
|
delivery
|
APGAR scores
Time Frame: delivery
|
chart review
|
delivery
|
NICU admissions
Time Frame: delivery
|
chart review
|
delivery
|
delivery complications (shoulder dystocia, low birth weight)
Time Frame: delivery
|
chart review
|
delivery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sara N Iqbal, MD, Medstar
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20223247
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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