The (cost) effectiveness of an online intervention (MamaKits) for pregnant women with affective symptoms: a randomised controlled trial

Background
Women in pregnancy and postpartum have an increased vulnerability to develop an
affective disorder. The prevalence of depressive disorder, respectively anxiety
disorder during pregnancy is 12 and 11% [1]. Prevalence rates of mild affective
symptoms is 17% [2]
Affective disregulation in pregnancy is often not diagnosed because the
overlapping symptomatology with pregnancy itself. It remains therefore often
not recognised as a (developing) depressive or anxiety disorder [3]
Both depression and anxiety disorders - affective disorders - are associated
with adverse perinatal outcomes such as an increased risk of prematurity,
dysmaturity and impaired development [4,5,6]. Untreated affective disorders
and their complications may also result in considerable cost [7] Moreover,
antenatal depressive and/ or anxiety symptoms are a risk factor for the
development of post partum depressive disorder [8,9]. Prevention of the
occurrence of an affective disorder during pregnancy is therefore important for
mother, child and society at large.

A recent meta-analysis, which included 28 RCT*s, showed that pre- and
postpartum psychological interventions reduced the number of women who
developed postpartum depression [10]. Postpartum interventions were more
effective than prepartum interventions, interventions aimed at women at high
risk were more effective than interventions aimed at all women and individual
interventions were more effective than group interventions. Attrition due to
the fact that there are many unique barriers for pregnant women and new mothers
to attend sessions outside their home, was noted as one of the main problems to
accomplish a sufficient intervention dose. The following interventions appear
to show promise in the prevention of postpartum depressive disorder: lay
telephone support, home visits by nurses, and interpersonal therapy (IPT).
There were no studies which used (Internet) self-help programs.

An internet-based self-help intervention can overcome various barriers with
respect to face-to-face interventions as it is easy accessible, home-based and
can be followed in one*s own time. There is no waiting list and there is also
a reduction in therapist time and -costs. The intervention is therefore a
promising approach in the treatment of affective disregulation in pregnant
women.

In recent years self- help programs have become increasingly popular in mental
health care. These interventions are based on evidence based psychological
treatments and can be provided in different formats, e.g. in book-format as
so-called *bibliotherapy* or online. Nowadays, numerous randomized controlled
trials are available that demonstrate the effectiveness of internet-based
self-help interventions for different mental disorders such as depression
[11,12], anxiety [13,14], alcohol [15], and insomnia [16]. Various treatment
modalities have been applied within these trials. For example, Cognitive
Behavioural Therapy (CBT) and Problem-Solving Therapy (PST). It has
demonstrated that (Internet) self-help treatments that are provided with
support are more effective than those without any support [17].
To our best knowledge no evidence based self-help internet intervention for
affective disregulation in pregnancy is available yet.

We will examine effectiveness of the internet-based self-help intervention
compared to a waiting list control condition on (1) reduction of depressive
and anxiety symptoms post intervention and 6 weeks post-partum and (2)
improvement in perinatal outcome (pre-term birth and growth restriction). We
will (3) determine cost-effectiveness using a societal perspective alongside.

Study design
The study is a randomized controlled trial with an active intervention arm and
a waiting list control condition.
The intervention is based on problem solving treatment and will be offered
through the internet. It will be guided by a professional coach. Participants
in the control condition and women who applicate when they are more than 30
weeks pregnant are offered access to an online depression treatment after the
last follow-up of the trial (6 weeks post partum). Both groups are allowed to
use treatment as usual as well. Additional care use will be registered.

*MamaKits online* is based on an internet version of PST, which is proven
effective for reducing anxiety and depressive symptoms in the general adult
population [22]. The core assumption of PST is that depressive and anxiety
symptoms are generated when people become overwhelmed by practical problems
they face in their daily lives. When people are able to make a list of their
worries and problems, and learn structured ways to resolve them, they feel less
overwhelmed, are better able to cope and this will in turn alleviate their mood
[23].
The course takes 6 weeks to complete, with one lesson each week. Each lesson
consists of: information, examples and homework assignments. The intervention
consists of three steps: 1. Participants describe what really matters to them.
2. Participants write down their current worries and problems and categorize
them into three types: (a) unimportant problems (problems unrelated to the
things that matter to them), (b) problems that can be solved, and (c) problems
that cannot be solved (e.g. the loss of a loved one). 3. Participants make a
plan for the future in which they describe how they will try to accomplish
those things that matter most to them.
The core of the intervention consists of a structured approach to solve
potentially solvable problems. It consists of six steps: (1) write a clear
definition of the problem, (2) generate multiple solutions to the problem, (3)
select the best solution, (4) work out a systematic plan for this solution, (5)
carry out the solution, and (6) evaluate as to whether the solution has
resolved the problem.
Trained coaches will give weekly feedback on the assignments through e-mail.
Based on previous experience with e-mail coaching we expect this to take 15
minutes per participant per lesson. Feedback is aimed at supporting
participants to work through the intervention and assignments, not to develop a
therapeutic relationship. The e-mail support will be provided by trained
prevention workers who have experience in providing mental health services to
pregnant women. They work within a mental health care organization in
Amsterdam. The main researcher and experienced psychiatrist (HH) will check the
integrity of these supportive e-mails.

Burden is estimated very small and consists predominantly of filling in
questionnaires for about 2 hours pro participant for the whole study of 9
months. Additionally it is expected from the treatmentgroup that they spend 3
hours a week to the course. In the questionnaires there are one or 2 questions
about the psychiatric history. The remaining questions and also the treatment
course are aimed at present problems and their solvability. The risk of the
intervention is very small.