Aims of the study:1. To evaluate the effect of a guided self-help resilience training for pregnant women with depressive symptomatology on:a) primary outcomes: maternal depressive symptoms and resilience; andb) secondary outcomes including maternal…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
primary maternal outcomes:
- mood disturbances
- resilience
Secondary outcome
secundary maternal psychosocial outcomes:
- depression incidence
- *flourishing*
- quality of life
- anxiety
- PTSS symptoms
- experience of birth
- mother-child bonding
- parenting skills (mindful parenting)
secundary maternal biological outcomes:
- pregnancy outcomes
- stresshormone cortisol
secundary child outcomes:
- birth outcomes
- developmental landmarks
- temperament
Background summary
Depression is an increasing major public health problem in the Netherlands.
Between 10 to 20% of pregnant women experience depressive symptoms. Moreover,
in 60% of the cases these symptoms are not recognized by healthcare providers.
Antepartum depressive symptoms are associated with peripartum depression, low
quality of life, prematurity and long-term developmental and behavioral
problems.
This emphasizes the need to prevent the consequences of antepartum depressive
symptoms for both mother and child. Current evidence regarding the
effectiveness of antepartum psychological interventions is inconsistent and
mainly based on face-to-face interventions with high rates of drop-out and low
rates of adherence. Therefore, an alternative, non-stigmatizing and accessible
approach to prevent peripartum depression is necessary. Resilience, the
ability to deal with challenges, setbacks, and misfortune, is inversely
associated with depressive symptoms and can be trained. Previously, a self-help
resilience training, based on Acceptance and Commitment Therapy (ACT), has
repeatedly been shown to effectively reduce depressive symptoms among
non-pregnant populations. The current project is the first randomized clinical
trial (RCT) with 6 months follow-up which evaluates the efficacy of a
pregnancy-specific guided self-help resilience training, based on ACT, designed
to reduce depressive symptoms and improve resilience.
Correspondingly, there is a need for more knowledge of the underlying
mechanisms of the possible relationship between maternal prepartum resilience,
peripartum psychological functioning and perinatal and infant development
outcomes. One of the neurobiological mechanisms underlying the associations
between maternal antenatal psychological dysfunction such as depression and
adverse maternal and child outcomes may be an altered
hypothalamic-pituitary-adrenal (HPA) axis, reflected by increased or decreased
maternal cortisol levels in pregnancy and henceforth transmitted to the fetus.
There is, however, a need for more research into haircortisol as a (potential)
valid indicator of prenatal depression.
To consider possible effects of experiences of respondents during the *Corona
crisis*, information regarding these experiences will be taken into account.
Study objective
Aims of the study:
1. To evaluate the effect of a guided self-help resilience training for
pregnant women with depressive symptomatology on:
a) primary outcomes: maternal depressive symptoms and resilience; and
b) secondary outcomes including maternal psychosocial functioning and
developmental outcomes of the (unborn) child.
2. To identify psychosocial factors (e.g., anxiety) that predict which pregnant
women with depressive symptomatology do or do not benefit from the guided
self-help resilience training.
3. To identify psychosocial factors (e.g., psychological flexibility) that
mediate the possible effect of the antepartum guided self-help resilience
training on depressive symptoms, resilience and infant developmental outcomes.
4. To examine experiences of pregnant women that participated in the guided
self-help resilience training, their e-mail coaches and midwives.
Cohort study:
5. To explore the psychosocial profiles (based on, e.g., maternal prenatal
stress) and demografic profiles of pregnant women with absent/low, subclinical
and clinical depressive symptoms and flourishing
6. To identify a) longitudinal trajectories of different levels of depressive
symptoms in the peripartum period and b) to identify maternal psychosocial
characteristics (e.g. maternal prenatal stress), infant characteristics and the
level of resilience characterizing these trajectories.
7. To study the relationship between resilience and different levels of
peripartum depressive symptoms during time.
8. (a) To study the association of maternal prepartum factors associated with
resilience (e.g. psychological flexibility, mindfulness) and maternal prenatal
stress (due to the Corona-crisis) with pregnancy and birth outcomes, perinatal
outcomes, and infant behavioral and cognitive developmental outcomes; and (b)
to study whether maternal prenatal resilience and experienced continuity of
midwifery care ameliorate the influence of maternal prenatal stress on
peripartum depressive symptoms and infant behavioral and cognitive
difficulties.
9.To assess the cortisol concentration from scalphair of pregnant women with a
low, moderate or severe lvel of depressive symptoms in the second trimester of
pregnancy.
10. To study the association between haircortisol and the level of depressive
symptoms, resilience, anxiety and birth-outcomes and infant development.
Study design
A RCT with two conditions: A guided self-help resilience training
(intervention) versus care as usual (control group = regular perinatal care)
An observational longitudinal cohort study. Additional analysis of haircortisol
from randomly selected participants of the main study with varying
symptomlevels of antenatal depression.
Intervention
The resilience training includes multiple components designed to increase
resilience and to reduce depressive symptoms.
The training is based on a self-help book *Living to the full*, applying
Acceptance and Commitment Therapy (ACT) via 9 modules that will be followed by
the participants during a 9-weeks period (Bohlmeijer & Hulsbergen, 2008). 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 (Hayes et
al., 2006). During the 9-weeks training participants will follow 9 modules as
described in the self-help book *Living to the full* (Bohlmeijer & Hulsbergen,
2008). These modules are clustered into three parts. In the first part of the
book, participants are asked to reflect on their avoidance and control
strategies and whether these strategies are effective on the long run. In the
second part, participants learn how to come into contact with their present
experiences without trying to avoid or control them. In addition, they practice
cognitive defusion and experiencing self as context. In the third part,
participants learn to become aware of the most important personal values and to
make decisions based on these values. Each module includes experiential
exercises and metaphors for illustrating the processes of ACT. Moreover, the
participants were asked to do daily mindfulness exercises, based on
mindfulness-based stress reduction (Kabat-Zinn, 1990, 1994). The mindfulness
exercises lasted on average 10-15 minutes and were on an audio CD which was
included in the book. Next to the book, participants receive a
pregnancy-specific supplement describing in a positive and non-stigmatizing
manner how pregnant women with depressive symptomatology can use to the
self-help book.
Each week during the training period participants receive an e-mail by their
trained coach referring to the content of the respective module participants
followed in the week before, in line with the approach by Fledderus et al.
(2012). In this e-mail participants are asked about their experiences with the
respective module and about their progress. The purpose of the e-mail support
is to motivate and to support participants while following the training and
modules. To follow the development of the depressive symptomatology,
participants will be asked to fill in the PGIC. The e-mail support will be
supervised by a trained clinical psychologist.
Study burden and risks
During 5 measurement periods participants will be asked to fill in digital
questionnaires. Those with a score >=11 on the Edinburgh Depression Scale
(EPDS) during T0 (baseline measurement) will be asked to partcipate in a short
psychiatric interview (MINI; 10-15 minutes) to further assess the severity of
depressive symptomatology. The half of the participants will follow a guided
self-help resilience training whereas the other half participates in the
control group (i.e., regular perinatal care).
There are no risks involved for the participants of this study.
The intervention will be supervised by a clinical psychologist and the
development of depressive symptomatology will repeatedly be monitored during
the intervention period. The intervention concerns a guided self-help
intervention asking participants to carry out experiential practices. They will
receive e-mail support from their coaches. Such support is known to increase
participants* motivation and adherence levels. The study population concerns a
subclinical population with depressive symptomatology.
Pregnant women will participate in a preventative intervention for which they
will be selected based on a two-steps psycho-diagnostic recruitment procedure.
As the current intervention has already been proven to be effective in other
populations, it is likely that included pregnant women may benefit from the
intervention (even on the long run).
Hairsampling for cortisol is non-invasive and will take place via one homevisit
of a trained researchnurse- or researchassistant. Only a small randomly
selected subpopulation will be approached for the hairsampling substudy.
van der Boechorststraat 7
Amsterdam 1081BT
NL
van der Boechorststraat 7
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
- pregnant <18 weeks
- RCT: Edinburgh Postnatal Depression Scale (EPDS) score >= 11 (Bergink et
al., 2011)
- Haircortisol: a hairlength of at least 3 cm. and sufficiënt hair growth
at the posterior vertex position of the head.
Exclusion criteria
- poor literacy in Dutch
- functional illiteracy
- RCT: severe clinical depression
- RCT: psychopharmacological and/or psychological therapy started within the
last three months
- Haarcortisol: cortisocosteroids intake in the past 3 months.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL64740.029.18 |
OMON | NL-OMON20234 |