Pregnancy RelatedNCT05503056
Art Therapy in Obstetric Patients
A study testing art therapy and nothing in people with Pregnancy Related and Depression, run by Medstar Health Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Depression
- What is being tested?
- art therapy and nothing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 13 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women who do not meet those criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: The Utilization of Art Therapy During Pregnancy to Reduce the Incidence of Postpartum Depression
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.
Read the 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.
- Conditions
- Pregnancy Related, Depression
- Being tested
- art therapy, nothing
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
art therapyOther
six sessions of art therapy with licensed therapists
nothingOther
no intervention to this group
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Engage in six art therapy sessions Receives: Other: art therapy |
| Control | Placebo comparator | Engage in usual activities Receives: Other: nothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in Edinburgh Postnatal Depression Scale scores
raw score on scale
Measured: 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
Measured: 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"
Measured: 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"
Measured: 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)
chart review
Measured: up to 3 months postpartum
gestational age at time of delivery
chart review
Measured: delivery
mode of delivery
chart review
Measured: delivery
reason for delivery (iatrogenic vs spontaneous)
chart review
Measured: delivery
birth weight
chart review
Measured: delivery
APGAR scores
chart review
Measured: delivery
NICU admissions
chart review
Measured: delivery
delivery complications (shoulder dystocia, low birth weight)
chart review
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Sep 2022
- Primary completion30 Aug 2023
- Study completion13 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara N. Iqbal, Medstar Health Research Institute
- Investigators
- Sara N Iqbal, MD, Principal investigator, MedStar Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503056
- Sponsor's protocol ID
- 20223247
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29412335
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of Art Therapy During Pregnancy to Reduce the Incidence of Postpartum Depression
- ClinicalTrials.gov ID
- NCT05503056
- Acronym / sponsor ID
- 20223247
- Conditions
- Pregnancy Related, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 13 Apr 2024 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: art therapyEngage in six art therapy sessions |
| Control | Placebo comparator | Other: nothingEngage in usual activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Women who do not meet those criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| art therapysix sessions of art therapy with licensed therapists | Other | Intervention |
| nothingno intervention to this group | Other | Control |
Primary outcome
changes in Edinburgh Postnatal Depression Scale scores
Time frame: start, 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
Time frame: start, 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
Time frame: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
chart review to see if patients utilized services "yes" vs. "no"
use of psychiatry medications during and after pregnancy
Time frame: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum
chart review to see if patients utilized services "yes" vs. "no"
8 secondary outcomes
obstetrical complications (postpartum hemorrhage, OASIS, ICU admission)
Time frame: up to 3 months postpartum
gestational age at time of delivery
Time frame: delivery
mode of delivery
Time frame: delivery
reason for delivery (iatrogenic vs spontaneous)
Time frame: delivery
birth weight
Time frame: delivery
APGAR scores
Time frame: delivery
NICU admissions
Time frame: delivery
delivery complications (shoulder dystocia, low birth weight)
Time frame: delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 29412335Ciasca 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara N Iqbal, MD principal investigator
MedStar Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing art therapy and nothing in people with Pregnancy Related and Depression, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in Edinburgh Postnatal Depression Scale scores (time frame: start, and end of intervention period; time of delivery, two weeks postpartum, six weeks postpartum, three months postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05503056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.