NCT06807801

Brief Summary

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.

Trial Health

77
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
15mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Feb 2024Aug 2027

Study Start

First participant enrolled

February 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

2.6 years

First QC Date

January 29, 2025

Last Update Submit

January 29, 2025

Conditions

Keywords

depressionattachmentpostpartumbaby swimming

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms

    Self-reported depressive symptoms measured by the Edinburgh Postnatal Depression Scale

    Seven months follow up

Secondary Outcomes (1)

  • Attachment

    Seven months follow up

Study Arms (2)

Waiting list

ACTIVE COMPARATOR

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).

Behavioral: Baby swimming

Intervention

ACTIVE COMPARATOR

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.

Behavioral: Baby swimming

Interventions

Baby swimmingBEHAVIORAL

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.

InterventionWaiting list

Eligibility Criteria

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

You may qualify if:

  • Women who have
  • given birth at full term
  • are 18 years or older
  • exhibit depressive symptoms according to the EPDS scale.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Alkistis Skalkidou, PhD, MD

CONTACT

Sara Sylvén, PhD, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The project is an interventional study in the form of an RCT with a waitlist control group and will be conducted at Uppsala University Hospital.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 4, 2025

Study Start

February 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

February 4, 2025

Record last verified: 2025-01

Locations