Depression - Major Depressive DisorderBIDAPNCT06807801
Baby Swim As an Intervention for Depressive Symptoms and Lacking Attachment During the Postpartum Period
A study testing Baby swimming in people with Depression - Major Depressive Disorder and Attachment, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression - Major Depressive Disorder, Attachment, Postpartum
- What is being tested?
- Baby swimming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2024to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Baby swimming
- Keywords
- depression, attachment, postpartum, baby swimming
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby swimmingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Baby swimming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Self-reported depressive symptoms measured by the Edinburgh Postnatal Depression Scale
Measured: Seven months follow up
Secondary outcomes (1)
Attachment
Measured by the Postpartum Bonding Questionnaire
Measured: Seven months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Feb 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807801
- Sponsor's protocol ID
- BIDAP
- Acronym
- BIDAP
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIDAP - Baby Swim As an Intervention for Depressive Symptoms and Lacking Attachment During the Postpartum Period
- ClinicalTrials.gov ID
- NCT06807801
- Acronym / sponsor ID
- BIDAP / BIDAP
- Keywords
- depression, attachment, postpartum, baby swimming
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 4 Feb 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Waiting list | Active comparator | Behavioral: Baby swimmingAfter 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). |
| Intervention | Active comparator | Behavioral: Baby swimmingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Baby swimmingParticipants 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. | Behavioural | Intervention, Waiting list |
Primary outcome
Depressive symptoms
Time frame: Seven months follow up
Self-reported depressive symptoms measured by the Edinburgh Postnatal Depression Scale
1 secondary outcome
Attachment
Time frame: Seven months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Depression - Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby swimming in people with Depression - Major Depressive Disorder and Attachment, run by Uppsala University at 1 site in Sweden.
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 3 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: looking for participants now, as of the sponsor's last update on 4 Feb 2025. 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 Sweden. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alkistis Skalkidou, PhD, MD (+46 6110000, alkistis.skalkidou@kbh.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: Seven months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2025.