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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05503056
Other study ID # 20223247
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date April 13, 2024

Study information

Verified date April 2024
Source Medstar Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
art therapy
six sessions of art therapy with licensed therapists
nothing
no intervention to this group

Locations

Country Name City State
United States Washington Hospital Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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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