- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06807801
Baby Swim As an Intervention for Depressive Symptoms and Lacking Attachment During the Postpartum Period (BIDAP)
BIDAP - Baby Swim As an Intervention for Depressive Symptoms and Lacking Attachment During the Postpartum Period
Mental health issues are very common during and after pregnancy, and studies from around the world indicate that 10-15% of all pregnant and postpartum women experience depression. Risk factors for developing depression include a history of depression, low levels of social support, and stressful life events. The symptoms are the same as for depression during other periods of life, but often include feelings of inadequacy regarding motherhood, along with associated feelings of shame or guilt. Obsessive thoughts directed toward the baby may also be part of the symptomatology. Such thoughts are typically experienced as frightening by the mother but, in the vast majority of cases, do not pose any risk to the child. Maternal depression can also affect a mother's ability to bond with her baby, and difficulties in forming an attachment can, in turn, increase and perpetuate depressive symptoms. In the long term, insecure attachment between mother and child can lead to behavioral problems in the child, such as aggression and avoidance, anxiety and depression in adolescence, negative effects on cognitive development, and trust issues in close relationships.
Baby swimming is a structured form of interaction that takes place in 34-degree Celsius water in a calm environment, aiming to teach the baby vital skills while stimulating social, intellectual, and motor development. At least one parent actively participates and is encouraged to perform various exercises. These activities strengthen the bond between the baby and the parent and contribute to making time in the water a safe and enjoyable experience. Previous studies have shown that baby swimming can improve attachment between parent and child.
In the present project, the aim is to investigate whether baby swimming can be used as an intervention for depressive symptoms in new mothers and whether this intervention can reduce depressive symptoms while also strengthening the bond between mother and child.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alkistis Skalkidou, PhD, MD
- Phone Number: +46 6110000
- Email: alkistis.skalkidou@kbh.uu.se
Study Contact Backup
- Name: Sara Sylvén, PhD, MD
- Phone Number: +46706110451
- Email: sara.sylven@neuro.uu.se
Study Locations
-
-
-
Uppsala, Sweden
- Recruiting
- Uppsala University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Women who have
- given birth at full term
- are 18 years or older
- have a baby aged 3-7 months at the time of inclusion
- exhibit depressive symptoms according to the EPDS scale.
Exclusion Criteria:
- Multiple pregnancy (twins, triplets)
- Known psychotic disorder or bipolar disorder
- Inability to communicate adequately in Swedish or English, or inability to read and complete digital questionnaires in Swedish or English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Waiting list
After completing the baseline questionnaire at T0, participants will be randomized into two groups: half will receive the intervention immediately (the treatment group), while the other half will receive it after seven months (the waitlist control group).
|
Participants in the treatment group will be contacted by a researcher and invited to an introductory meeting at the swimming facility, where they will receive information about the baby swimming course from the instructor.
The course will take place twice a week for five weeks, totaling 10 sessions of 30 minutes each.
During the sessions, mothers will be encouraged to engage in physical contact, maintain eye contact, and respond to their baby's signals.
The course will also include water safety exercises.
|
|
Active Comparator: Intervention
Participants in the treatment group will be contacted by a researcher and invited to an introductory meeting at the swimming facility, where they will receive information about the baby swimming course from the instructor.
The course will take place twice a week for five weeks, totaling 10 sessions of 30 minutes each.
During the sessions, mothers will be encouraged to engage in physical contact, maintain eye contact, and respond to their baby's signals.
The course will also include water safety exercises.
|
Participants in the treatment group will be contacted by a researcher and invited to an introductory meeting at the swimming facility, where they will receive information about the baby swimming course from the instructor.
The course will take place twice a week for five weeks, totaling 10 sessions of 30 minutes each.
During the sessions, mothers will be encouraged to engage in physical contact, maintain eye contact, and respond to their baby's signals.
The course will also include water safety exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms
Time Frame: Seven months follow up
|
Self-reported depressive symptoms measured by the Edinburgh Postnatal Depression Scale
|
Seven months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attachment
Time Frame: Seven months follow up
|
Measured by the Postpartum Bonding Questionnaire
|
Seven months follow up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIDAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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