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ID
Source
Brief title
Health condition
Antepartum depression
Sponsors and support
Intervention
Outcome measures
Primary outcome
- depressive symptoms
- resilience
Secondary outcome
Secondary maternal psychosocial outcomes:
- depression incidence
- 'flourishing'
- quality of life
- anxiety
- PTSS symptoms
- experience of birth
- mother-child bonding
- parenting skills (mindful parenting)
Secondary maternal biological outcomes:
- pregnancy outcomes
Secondary child outcomes:
- birth outcomes
- developmental milestones
- temperament
Background summary
Depression among pregnant women is a prevalent public health care problem related to poor maternal and offspring outcome. Up to 20% of women experience depressive symptoms during their pregnancy. Prenatal depressive symptoms are associated with peripartum major depression, low maternal quality of life, premature birth, low birthweight and long-term emotional, cognitive and behavioral problems in the child. Therefore, early detection and intervention is crucial.
However, psychological interventions generally offered to pregnant women, as cognitive behavioural therapy (CBT) or inter personal therapy (IPT), are shown to have inconsistent and only moderate effects in preventing and treating prenatal depression partly due to high drop-out rates. Acceptance and Commitment Therapy (ACT) may be suitable as early easy accessible non-stigmatizing intervention for peripartum depressive symptoms because of its proven effectiveness on mild to moderate depressive symptoms and in the promotion of positive mental health. In this RCT, the effectiveness of a self-guided resilience training based on ACT and mindfulness, Living to the full during pregnancy (Voluit zwanger), will be evaluated.
This RCT is embedded in an observational cohort study investigating the underlying mechanisms of the possible relationship between maternal peripartum resilience, psychological functioning and perinatal and infant development outcomes.
Study objective
The primary aim of the RCT is to evaluate the effect of a guided self-help resilience training for pregnant women with depressive symptomatology on maternal depressive symptoms and resilience and secondary outcomes including maternal psychosocial functioning and developmental outcomes of the (unborn) child.
We expect the intervention group to be superior in outcomes on depression, resilience and secondary outcomes in comparison with the CAU control group at the end of the intervention during pregnancy and follow-up at 6 and 18 weeks postpartum.
Exploratively, we want to examine to what extent certain baseline characteristics are predictive of treatment outcome (effect modification) and to what extent changes in psychosocial factors (e.g. psychological flexibility) mediate the intervention effects.
Experiences of pregnant women that participated in the guided self-help resilience training will be evaluated.
Study design
- second trimester
- third trimester
- 6 weeks postpartum
- 18 weeks postpartum
Intervention
The intervention is based on a self-help book ‘Living to the full’, applying Acceptance and Commitment Therapy (ACT) via 9 chapters that will be followed by the participants during a 9-weeks period. In line with ACT this self-help book uses multiple components and strategies, i.e. acceptance, commitment, and mindfulness based strategies and behavior change strategies to increase both psychological flexibility and resilience.
Inclusion criteria
- Women with singleton pregnancies <18 weeks
- RCT: Edinburgh Postnatal Depression Scale (EPDS) score ≥11
Exclusion criteria
- Poor literacy in Dutch
- Functional illiteracy
- RCT: severe clinical depression
- RCT: psychopharmacological and/or psychological therapy started within the last three months
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7499 |
CCMO | NL64740.029.18 |
OMON | NL-OMON52869 |