In a randomized control trial (RCT) with mothers with postpartum depressive symptoms the following main hypotheses will be tested:• Oxytocin will promote more sensitive caregiving during mother-infant interactions and while interacting with a life-…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are:
- Maternal sensitivity during interaction with mother*s own infant and with a
crying infant simulator
- Maternal stress reactivity, assessed with heart rate and salivary cortisol
- Recognition of infant facial emotional expressions
Secondary outcome
• We will examine the extent to which effects of oxytocin are moderated by
mothers* early childhood experiences. Early childhood experiences are known to
moderate effects of nasally administered oxytocin (Ellis et al., 2021, see
research protocol), possibly also in mothers with postpartum depression.
• We will examine whether oxytocin affects mothers* mood and the perceived
relationship with her child.
Background summary
Postpartum depression is a serious mental health concern affecting 10-15% of
all mothers in Western societies. Postpartum depression does not only
negatively impact on the mother, but has also been associated with insensitive
caregiving and with poor child outcomes. One candidate that may play a crucial
role in the relation between depressed mood, maternal care, and child outcomes
is oxytocin, a hormone important for affiliation and parenting. Previous
studies have shown that oxytocin levels are lower in mothers with postpartum
symptoms and that intranasal oxytocin administration can positively affect the
perceived relationship with the child. However, still little is known about the
effects of oxytocin on caregiving behavior in mothers with postpartum
depression. Here, we propose to conduct a randomized double-blind
within-subject control study to test the effects of intranasal oxytocin on
caregiving behaviors of mothers with depressive symptoms in the postpartum
period.
Study objective
In a randomized control trial (RCT) with mothers with postpartum depressive
symptoms the following main hypotheses will be tested:
• Oxytocin will promote more sensitive caregiving during mother-infant
interactions and while interacting with a life-like crying infant simulator.
• Oxytocin will reduce depressed mothers* stress reactivity while interacting
with their own infant and the crying infant simulator, as reflected in reduced
heart rate activity and cortisol.
• Oxytocin administration will result in a bias towards the recognition of
happy infant emotions.
Secondary objectives are 1) to examine whether oxytocin affects mothers* mood
and the perceived relationship with her child and 2) to examine the extent to
which effects of oxytocin are moderated by mothers* early childhood
experiences.
Study design
A randomized controlled-trial with a within-subject design. Mothers with
postpartum depression will be invited for two lab sessions during which they
will receive a nasal spray containing 24 IU oxytocin or a placebo.
Intervention
24 IU intranasal oxytocin and placebo
Study burden and risks
There are no risks associated with the assessments used in this study. Possible
side effects of oxytocin are negligible. No adverse effects have been reported
in participants/patients. The burden for participants consists of spending time
on two lab sessions (approximately 75 minutes each), during which four saliva
samples will be collected, heart rate will be measured, questionnaires will be
completed, an infant emotion recognition task will be performed, and
mother-infant interactions will be observed. Although there is no direct
benefit to the participants from the proposed research, there are greater
benefits to society from the potential knowledge gained from this study. Once
we understand the neurobiological underpinnings of poor maternal sensitivity
among mothers with postpartum depression, better attempts can be made to
improve parenting and reduce the adverse effects of poor parenting. Moreover,
the study will reveal insight into the potential therapeutic effects of
oxytocin administration in mothers with depressive symptoms. Thus, the
importance of the benefits gained from this research outweighs the minimal
risks involved.
Montessorilaan 3
Nijmegen 6525 HR
NL
Montessorilaan 3
Nijmegen 6525 HR
NL
Listed location countries
Age
Inclusion criteria
• Mothers with a healthy infant between 0 and 9 months of age
• With a diagnosis of postpartum depression, that is, scores of >=7 on the
Edinburgh Postnatal Depression Scale and a postpartum depression diagnosis
confirmed through the Structured Clinical Interview for the DSM-5
Exclusion criteria
• Current mental disorder other than depression or an anxiety disorder
• PPD with psychotic symptoms
• Neurological disorders, endocrine diseases, cardiovascular diseases, nose
injuries and disorders, use of medication other than oral contraceptives or
anti-depressant medication
• Regular use of soft drugs, hard drug use within the past three months, or
excessive alcohol intake
• Pregnancy
• Preterm birth (< 37 weeks)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2022-000603-12-NL |
CCMO | NL80655.000.22 |