Back to resultsArt Therapy in High-risk Obstetric Patients
Primary Purpose
High Risk Pregnancy, Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
art therapy
nothing
Sponsored by
About this trial
This is an interventional supportive care trial for High Risk Pregnancy
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, and plan to deliver at Washington Hospital Center
Exclusion Criteria:
- Women who do not meet those criteria will be excluded from recruitment
Sites / Locations
- Washington Hospital CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Engage in six art therapy sessions
Engage in usual activities
Outcomes
Primary Outcome Measures
changes in Edinburgh Postnatal Depression Scale scores
raw score on scale
change in maternal-infant bonding scores
raw score on scale
utilization of behavioral health/psychology/psychiatry services during pregnancy and postpartum
chart review to see if patients utilized services "yes" vs. "no"
use of psychiatry medications during and after pregnancy
chart review to see if patients utilized services "yes" vs. "no"
Secondary Outcome Measures
obstetrical complications (postpartum hemorrhage, OASIS, ICU admission)
chart review
gestational age at time of delivery
chart review
mode of delivery
chart review
reason for delivery (iatrogenic vs spontaneous)
chart review
birth weight
chart review
APGAR scores
chart review
NICU admissions
chart review
delivery complications (shoulder dystocia, low birth weight)
chart review
Full Information
NCT ID
NCT05503056
First Posted
March 20, 2022
Last Updated
September 15, 2022
Sponsor
Medstar Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05503056
Brief Title
Art Therapy in High-risk Obstetric Patients
Official Title
The Impact of Art Therapy on Maternal Depression and Mother-infant Bonding in High-risk Pregnancies
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medstar Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Risk Pregnancy, Depression
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Engage in six art therapy sessions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Engage in usual activities
Intervention Type
Other
Intervention Name(s)
art therapy
Intervention Description
six sessions of art therapy with licensed therapists
Intervention Type
Other
Intervention Name(s)
nothing
Intervention Description
no intervention to this group
Primary Outcome Measure Information:
Title
changes in Edinburgh Postnatal Depression Scale scores
Description
raw score on scale
Time Frame
start, middle, and end of intervention period, time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
Title
change in maternal-infant bonding scores
Description
raw score on scale
Time Frame
start, middle, and end of intervention period, time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
Title
utilization of behavioral health/psychology/psychiatry services during pregnancy and postpartum
Description
chart review to see if patients utilized services "yes" vs. "no"
Time Frame
12-16 months
Title
use of psychiatry medications during and after pregnancy
Description
chart review to see if patients utilized services "yes" vs. "no"
Time Frame
12-16 months
Secondary Outcome Measure Information:
Title
obstetrical complications (postpartum hemorrhage, OASIS, ICU admission)
Description
chart review
Time Frame
one month postpartum
Title
gestational age at time of delivery
Description
chart review
Time Frame
one month postpartum
Title
mode of delivery
Description
chart review
Time Frame
one month postpartum
Title
reason for delivery (iatrogenic vs spontaneous)
Description
chart review
Time Frame
one month postpartum
Title
birth weight
Description
chart review
Time Frame
one month postpartum
Title
APGAR scores
Description
chart review
Time Frame
one month postpartum
Title
NICU admissions
Description
chart review
Time Frame
one month postpartum
Title
delivery complications (shoulder dystocia, low birth weight)
Description
chart review
Time Frame
one month postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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, and plan to deliver at Washington Hospital Center
Exclusion Criteria:
Women who do not meet those criteria will be excluded from recruitment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatimah Fahimuddin, MD
Phone
202-877-3067
Email
fatimah.z.fahimuddin@medstar.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara N Iqbal, MD
Organizational Affiliation
Medstar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatimah Fahimuddin, MD
Phone
202-877-3067
Email
fatimah.z.fahimuddin@medstar.net
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29412335
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.
Results Reference
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Art Therapy in High-risk Obstetric Patients
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