Depression Clinical Trial
Official title:
The Utilization of Art Therapy During Pregnancy to Reduce the Incidence of Postpartum Depression
| Verified date | April 2024 |
| Source | Medstar Health Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a prospective study examining the potential impact art therapy has on postpartum depression and mother-baby bonding in women. Women who receive care at Washington Hospital Center's will be recruited for this study.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | April 13, 2024 |
| Est. primary completion date | August 30, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Washington Hospital Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Medstar Health Research Institute |
United States,
Ciasca EC, Ferreira RC, Santana CLA, Forlenza OV, Dos Santos GD, Brum PS, Nunes PV. Art therapy as an adjuvant treatment for depression in elderly women: a randomized controlled trial. Braz J Psychiatry. 2018 Jul-Sep;40(3):256-263. doi: 10.1590/1516-4446-2017-2250. Epub 2018 Feb 1. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | changes in Edinburgh Postnatal Depression Scale scores | raw score on scale | start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum | |
| Primary | change in maternal-infant bonding scores | raw score on scale | start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum | |
| Primary | utilization of behavioral health/psychology/psychiatry services during pregnancy and 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 | |
| Primary | use of psychiatry medications during and after pregnancy | 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 | obstetrical complications (postpartum hemorrhage, OASIS, ICU admission) | chart review | up to 3 months postpartum | |
| Secondary | gestational age at time of delivery | chart review | delivery | |
| Secondary | mode of delivery | chart review | delivery | |
| Secondary | reason for delivery (iatrogenic vs spontaneous) | chart review | delivery | |
| Secondary | birth weight | chart review | delivery | |
| Secondary | APGAR scores | chart review | delivery | |
| Secondary | NICU admissions | chart review | delivery | |
| Secondary | delivery complications (shoulder dystocia, low birth weight) | chart review | delivery |
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