NCT05503056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

March 20, 2022

Last Update Submit

April 16, 2024

Conditions

Pregnancy RelatedDepression

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (8)

  • obstetrical complications (postpartum hemorrhage, OASIS, ICU admission)

    up to 3 months postpartum

  • gestational age at time of delivery

    delivery

  • mode of delivery

    delivery

  • reason for delivery (iatrogenic vs spontaneous)

    delivery

  • birth weight

    delivery

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Engage in six art therapy sessions

Other: art therapy

Control

PLACEBO COMPARATOR

Engage in usual activities

Other: nothing

Interventions

art therapyOTHER

six sessions of art therapy with licensed therapists

Intervention
nothingOTHER

no intervention to this group

Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Women who do not meet those criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related 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.

    PMID: 29412335BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sara N Iqbal, MD

    MedStar Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

March 20, 2022

First Posted

August 16, 2022

Study Start

September 1, 2022

Primary Completion

August 30, 2023

Study Completion

April 13, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)