- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06711809
Sleep, Oxytocin and Reward Processing in Women in the Postpartum Phase
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.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christian Benedict, PhD
- Phone Number: +46 18 471 43 30
- Email: christian.benedict@farmbio.uu.se
Study Contact Backup
- Name: Nina Goll, M. Sc.
- Phone Number: +49170 29 88918
- Email: nina.goll@uni-tuebingen.de
Study Locations
-
-
-
Uppsala, Sweden, 751 24
- University of Uppsala
-
Contact:
- Christian Benedict, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age: 18-40
- Biological sex/gender: female
- Swedish/English fluency
- Postpartum phase: 6 weeks to 1 year
Exclusion Criteria:
- Age < 18
- Neonatal complications
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
7 consecutive nights
|
|
subjective sleep
Time Frame: 7 consecutive days
|
Subjective sleep assessed by a daily sleep diary.
|
7 consecutive days
|
|
oxytocin levels
Time Frame: 7 consecutive days
|
Oxytocin levels assessed with saliva kits.
|
7 consecutive days
|
|
breastfeeding
Time Frame: 7 consecutive days
|
Assessment of breastfeeding behavior (onset, frequency and duration) with breastfeeding diaries.
|
7 consecutive days
|
|
bonding
Time Frame: 7 consecutive days
|
Bonding of mother and child assessed with questionnaires.
|
7 consecutive days
|
|
reward processing/motivation
Time Frame: 7 consecutive days
|
Assessment of effort-based motivation using the effort allocation task.
|
7 consecutive days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
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
- IRTG_P06_2
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.
Clinical Trials on Postpartum Depression
-
Women and Infants Hospital of Rhode IslandNot yet recruitingPostpartum Anxiety | Paternal Postpartum Depression
-
Bekelu Teka WorkuJimma UniversityNot yet recruitingPrenatal Depression | Mental Health Related Quality of Life | Maternal Postpartum Depression | Paternal Postpartum DepressionEthiopia
-
Jordan University of Science and TechnologyActive, not recruitingPostpartum Depression | Postpartum Depression (PPD)Jordan
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
Afyonkarahisar Health Sciences UniversityNot yet recruitingPostpartum Depression | Postpartum Anxiety
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States