Postpartum DepressionNCT06711809
Sleep, Oxytocin and Reward Processing in Women in the Postpartum Phase
An observational study of Postpartum Depression, run by International Research Training Group 2804 at 1 site in Sweden.
Trial summary
During and after pregnancy, a woman's body and brain undergo significant changes that help her adapt to caregiving and emotional needs. However, this period also makes women more susceptible to emotional disorders, such as peripartum depression (PPD), which affects about 10-15% of new mothers. 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
- Postpartum Depression
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Research participants will be recruited in the area of Uppsala, Sweden.
Who may be able to join
- Age: 18-40
- Biological sex/gender: female
- Swedish/English fluency
- Postpartum phase: 6 weeks to 1 year
Who cannot join
- Age < 18
- Neonatal complications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
University of Uppsala
Uppsala, Sweden, 751 24
Christian Benedict, PhD
About this study
Official title: The Role of Sleep, Oxytocin and Reward Processing in Women in the Postpartum Phase
During and after pregnancy, a woman's body and brain undergo significant changes that help her adapt to caregiving and emotional needs. However, this period also makes women more susceptible to emotional disorders, such as peripartum depression (PPD), which affects about 10-15% of new mothers. PPD can negatively impact both the mother and her baby, disrupting mood, motivation, and mothering abilities. Hormonal changes and poor sleep are some of the risk factors that might worsen these depressive symptoms.
Traditionally, sleep studies on PPD have relied on questionnaires and short-term sleep assessments. With the advent of smartwatches and digital devices, we can now monitor sleep in a home environment over longer periods. Oxytocin, a hormone crucial for childbirth, breastfeeding, and bonding with the baby, is thought to play a role in PPD. Studies suggest that higher levels of oxytocin might be linked to lower levels of postpartum depression, though findings are not always consistent. Oxytocin also affects sleep and is connected to brain areas that regulate reward and motivation.
Read more
This study aims to explore the relationship between sleep, oxytocin, and reward processing in new mothers. The investigators will include women with varying levels of depressive symptoms and use home-based sleep assessments to gather data. Our goal is to better understand how these factors interact in the postpartum period and how they might influence a mother's mental health and caregiving abilities.
The investigators expect that oxytocin levels are reduced in women with higher depressive symptoms and that these reductions are associated with sleep impairments, breastfeeding and altered reward processing.
Read the detailed description
The study will be conducted at Uppsala University. Data will be mainly collected at the participants' home. The investigators plan to include 100 women in the postpartum phase in total, including women with different depressive scores according to the Edinburgh Postnatal Depression Scale (EPDS). Ideally, the investigators aim to include 50 women with depressive symptoms (EPDS ≥12) and 50 women without depressive symptoms (EPDS score ≤6). However, depending on the number of available participants and recruitment efforts the investigators will possibly include all interested women in the postpartum phase to increase the feasibility of the study and use a continuous categorization of the depressive (EPDS) scores.
The participants will be asked to fill out (online) questionnaires. The investigators will assess their demographic data and socioeconomic status as well depressive symptoms (Montgommery Asberg Depression Scale (MADRS); Edinburgh Postnatal Depression Score (EPDS)) and sleep/chronotype (morningness-eveningness questionnaire (MEQ); Pittsburg Sleep Quality Index (PSQI); Ford Insomnia Response to Stress Test (FIRST); Insomnia severity index (ISI); Epworth sleepiness scale (ESS); Fatigue Severity Scale (FSS)). Additionally, the investigators will include sleep questionnaires which are specific for the postpartum phase (Postpartum Sleep Quality Scale (PSQS)) and ask the mothers to rate the infants sleep using the Brief Infant Sleep Questionnaire (BISQ-R). Participants will be asked to fill out questionnaire regarding their breastfeeding behavior (Breastfeeding Self-Efficacy Scale Short Form (BSES-SF); Baby Eating Behavior Questionnaire (BEBQ)), bonding (Postpartum Bonding Questionnaire (PBQ); Swedish mother to infant bonding scale (S-MIBS)) and reward processing (indecisiveness scale IS, action regulation ARES).
Participants will take part in an online behavioral task ("Effort Allocation Task (EAT)") that assesses reward processing, in particular motivation for primary rewards (i.e. food) and secondary rewards (i.e. money) (approximately 20 minutes).
The experimenter will explain all the procedures for the at-home assessment and participants will be given the devices accordingly. For the at-home measurement of sleep, participants will receive tracking devices (Fitbit Inspire; Withings sleep analyser) which they should use for one week (7 days) to assess sleep multimodally. The Fitbit will also assess daily physiological measures i.e., physical activity during the day and heart rate. Additionally, subjective sleep, breastfeeding and the current mood will be assessed at several timepoints throughout the week using standardized diaries and questionnaires.
Furthermore, the participants will receive saliva sample kits to use at different timepoints throughout the measurement period to assess endogenous oxytocin levels. If participants are breastfeeding, the investigators will additionally ask them to take saliva samples before and after a breastfeeding period to assess changes in salivary oxytocin associated with breastfeeding.
- Conditions
- Postpartum Depression
- Keywords
- oxytocin, peripartum depression, postpartum depression, sleep, sleep assessment, reward processing, motivation
- Medical subject headings
- Depression, Postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
objective sleep
Objective sleep measures assessed with tracking devices (Fitbit Inspire; Withings sleep analyser) e.g., total time spent in bed, wake time, wake frequency, sleep stages duration.
Measured: 7 consecutive nights
subjective sleep
Subjective sleep assessed by a daily sleep diary.
Measured: 7 consecutive days
oxytocin levels
Oxytocin levels assessed with saliva kits.
Measured: 7 consecutive days
breastfeeding
Assessment of breastfeeding behavior (onset, frequency and duration) with breastfeeding diaries.
Measured: 7 consecutive days
bonding
Bonding of mother and child assessed with questionnaires.
Measured: 7 consecutive days
reward processing/motivation
Assessment of effort-based motivation using the effort allocation task.
Measured: 7 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Research Training Group 2804
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, Uppsala University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711809
- Sponsor's protocol ID
- IRTG_P06_2
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 2 Dec 2024
- 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 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sleep, Oxytocin and Reward Processing in Women in the Postpartum Phase
- ClinicalTrials.gov ID
- NCT06711809
- Acronym / sponsor ID
- IRTG_P06_2
- Conditions
- Postpartum Depression
- Keywords
- oxytocin, peripartum depression, postpartum depression, sleep, sleep assessment, reward processing, motivation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- International Research Training Group 2804University, hospital or other
- Collaborators
- Uppsala University, Uppsala University Hospital
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Dec 2024 (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.
During and after pregnancy, a woman's body and brain undergo significant changes that help her adapt to caregiving and emotional needs. However, this period also makes women more susceptible to emotional disorders, such as peripartum depression (PPD), which affects about 10-15% of new mothers. PPD can negatively impact both the mother and her baby, disrupting mood, motivation, and mothering abilities. Hormonal changes and poor sleep are some of the risk factors that might worsen these depressive symptoms.
Traditionally, sleep studies on PPD have relied on questionnaires and short-term sleep assessments. With the advent of smartwatches and digital devices, we can now monitor sleep in a home environment over longer periods. Oxytocin, a hormone crucial for childbirth, breastfeeding, and bonding with the baby, is thought to play a role in PPD. Studies suggest that higher levels of oxytocin might be linked to lower levels of postpartum depression, though findings are not always consistent. Oxytocin also affects sleep and is connected to brain areas that regulate reward and motivation.
This study aims to explore the relationship between sleep, oxytocin, and reward processing in new mothers. The investigators will include women with varying levels of depressive symptoms and use home-based sleep assessments to gather data. Our goal is to better understand how these factors interact in the postpartum period and how they might influence a mother's mental health and caregiving abilities.
The investigators expect that oxytocin levels are reduced in women with higher depressive symptoms and that these reductions are associated with sleep impairments, breastfeeding and altered reward processing.
Detailed description
The study will be conducted at Uppsala University. Data will be mainly collected at the participants' home. The investigators plan to include 100 women in the postpartum phase in total, including women with different depressive scores according to the Edinburgh Postnatal Depression Scale (EPDS). Ideally, the investigators aim to include 50 women with depressive symptoms (EPDS ≥12) and 50 women without depressive symptoms (EPDS score ≤6). However, depending on the number of available participants and recruitment efforts the investigators will possibly include all interested women in the postpartum phase to increase the feasibility of the study and use a continuous categorization of the depressive (EPDS) scores.
The participants will be asked to fill out (online) questionnaires. The investigators will assess their demographic data and socioeconomic status as well depressive symptoms (Montgommery Asberg Depression Scale (MADRS); Edinburgh Postnatal Depression Score (EPDS)) and sleep/chronotype (morningness-eveningness questionnaire (MEQ); Pittsburg Sleep Quality Index (PSQI); Ford Insomnia Response to Stress Test (FIRST); Insomnia severity index (ISI); Epworth sleepiness scale (ESS); Fatigue Severity Scale (FSS)). Additionally, the investigators will include sleep questionnaires which are specific for the postpartum phase (Postpartum Sleep Quality Scale (PSQS)) and ask the mothers to rate the infants sleep using the Brief Infant Sleep Questionnaire (BISQ-R). Participants will be asked to fill out questionnaire regarding their breastfeeding behavior (Breastfeeding Self-Efficacy Scale Short Form (BSES-SF); Baby Eating Behavior Questionnaire (BEBQ)), bonding (Postpartum Bonding Questionnaire (PBQ); Swedish mother to infant bonding scale (S-MIBS)) and reward processing (indecisiveness scale IS, action regulation ARES).
Participants will take part in an online behavioral task ("Effort Allocation Task (EAT)") that assesses reward processing, in particular motivation for primary rewards (i.e. food) and secondary rewards (i.e. money) (approximately 20 minutes).
The experimenter will explain all the procedures for the at-home assessment and participants will be given the devices accordingly. For the at-home measurement of sleep, participants will receive tracking devices (Fitbit Inspire; Withings sleep analyser) which they should use for one week (7 days) to assess sleep multimodally. The Fitbit will also assess daily physiological measures i.e., physical activity during the day and heart rate. Additionally, subjective sleep, breastfeeding and the current mood will be assessed at several timepoints throughout the week using standardized diaries and questionnaires.
Furthermore, the participants will receive saliva sample kits to use at different timepoints throughout the measurement period to assess endogenous oxytocin levels. If participants are breastfeeding, the investigators will additionally ask them to take saliva samples before and after a breastfeeding period to assess changes in salivary oxytocin associated with breastfeeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Research participants will be recruited in the area of Uppsala, Sweden.
Key inclusion criteria (4 listed)
- Age: 18-40
- Biological sex/gender: female
- Swedish/English fluency
- Postpartum phase: 6 weeks to 1 year
Key exclusion criteria (2 listed)
- Age < 18
- Neonatal complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
objective sleep
Time frame: 7 consecutive nights
Objective sleep measures assessed with tracking devices (Fitbit Inspire; Withings sleep analyser) e.g., total time spent in bed, wake time, wake frequency, sleep stages duration.
subjective sleep
Time frame: 7 consecutive days
Subjective sleep assessed by a daily sleep diary.
oxytocin levels
Time frame: 7 consecutive days
Oxytocin levels assessed with saliva kits.
breastfeeding
Time frame: 7 consecutive days
Assessment of breastfeeding behavior (onset, frequency and duration) with breastfeeding diaries.
bonding
Time frame: 7 consecutive days
Bonding of mother and child assessed with questionnaires.
reward processing/motivation
Time frame: 7 consecutive days
Assessment of effort-based motivation using the effort allocation task.
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 2 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression, run by International Research Training Group 2804 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 2 Dec 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 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 Christian Benedict, PhD (+46 18 471 43 30, christian.benedict@farmbio.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective sleep (time frame: 7 consecutive nights). The study lists 6 primary outcomes in all. 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 2 Dec 2024.