Art Therapy in High-risk Obstetric Patients

Sponsor

Medstar Health Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05503056

Collaborator

(none)

100

Enrollment

Location

Arms

22.5

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective study examining the potential impact art therapy has on postpartum depression and mother-baby bonding in women with high-risk pregnancies. Women who receive care at Washington Hospital Center's high-risk obstetrics clinic will be recruited for this study.

Condition or Disease	Intervention/Treatment	Phase
High Risk Pregnancy Depression	Other: art therapy Other: nothing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

The Impact of Art Therapy on Maternal Depression and Mother-infant Bonding in High-risk Pregnancies

Anticipated Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Engage in six art therapy sessions	Other: art therapy six sessions of art therapy with licensed therapists
Placebo Comparator: Control Engage in usual activities	Other: nothing no intervention to this group

Arm

Intervention/Treatment

Experimental: Intervention

Engage in six art therapy sessions

Other: art therapy

six sessions of art therapy with licensed therapists

Placebo Comparator: Control

Engage in usual activities

Other: nothing

no intervention to this group

Outcome Measures

Primary Outcome Measures

changes in Edinburgh Postnatal Depression Scale scores [start, middle, and end of intervention period, time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum]
raw score on scale
change in maternal-infant bonding scores [start, middle, and end of intervention period, time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum]
raw score on scale
utilization of behavioral health/psychology/psychiatry services during pregnancy and postpartum [12-16 months]
chart review to see if patients utilized services "yes" vs. "no"
use of psychiatry medications during and after pregnancy [12-16 months]
chart review to see if patients utilized services "yes" vs. "no"

Secondary Outcome Measures

obstetrical complications (postpartum hemorrhage, OASIS, ICU admission) [one month postpartum]
chart review
gestational age at time of delivery [one month postpartum]
chart review
mode of delivery [one month postpartum]
chart review
reason for delivery (iatrogenic vs spontaneous) [one month postpartum]
chart review
birth weight [one month postpartum]
chart review
APGAR scores [one month postpartum]
chart review
NICU admissions [one month postpartum]
chart review
delivery complications (shoulder dystocia, low birth weight) [one month postpartum]
chart review

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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, and plan to deliver at Washington Hospital Center

Exclusion Criteria:

Women who do not meet those criteria will be excluded from recruitment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington Hospital Center	Washington	District of Columbia	United States	20010

Sponsors and Collaborators

Medstar Health Research Institute

Investigators

Principal Investigator: Sara N Iqbal, MD, Medstar

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Sara N. Iqbal, Primary Investigator, Medstar Health Research Institute

ClinicalTrials.gov Identifier:

NCT05503056

Other Study ID Numbers:

20223247

First Posted:

Aug 16, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Aug 16, 2022