Clinical trial NCT05503056: Art Therapy in Obstetric Patients
Official title: The Utilization of Art Therapy During Pregnancy to Reduce the Incidence of Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Depression
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in Edinburgh Postnatal Depression Scale scores
timeFrame: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
measure: change in maternal-infant bonding scores
timeFrame: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
measure: utilization of behavioral health/psychology/psychiatry services during pregnancy and postpartum
timeFrame: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
measure: use of psychiatry medications during and after pregnancy
timeFrame: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
Secondary outcomes:
measure: obstetrical complications (postpartum hemorrhage, OASIS, ICU admission)
timeFrame: up to 3 months postpartum
measure: gestational age at time of delivery
timeFrame: delivery
measure: mode of delivery
timeFrame: delivery
measure: reason for delivery (iatrogenic vs spontaneous)
timeFrame: delivery
measure: birth weight
timeFrame: delivery
measure: APGAR scores
timeFrame: delivery
measure: NICU admissions
timeFrame: delivery
measure: delivery complications (shoulder dystocia, low birth weight)
timeFrame: delivery
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: MedStar Health
name: Sara N Iqbal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.