Major Depressive Disorder Clinical Trial
Official title:
Willkommen Mutterglück: A Controlled Trial of Internet Based Cognitive Behavioural Therapy (CBT) for Pregnant and Postpartum Women With Depression and Anxiety
This intervention study aims to evaluate the effectivity of web-based cognitive therapy in
reducing depression and anxiety in pregnant and postpartum women. Moreover, it aims to assess
treatment feasibility and usability of the treatment in the same population.
After an initial screening to determine the eligibility to participate, all participants
fulfilling the inclusion criteria will receive their personal access login in order to start
the intervention.
Introduction: Evidence has shown that 10-20% of women suffer from depression during gestation
and after birth (Barnes, 2014; Zaers, Waschke & Ehlert, 2008), while 7-21% present clinically
relevant anxiety levels prenatally and following delivery (Grant, McMahon & Austin, 2008).
Previous research has shown that if a woman has high levels of depression or anxiety during
pregnancy her child is at about double the risk for attention deficit hyperactivity disorder,
conduct disorders, difficult temperament and behavioural problems later in development
(O'Connor et al., 2002). High levels of prenatal anxiety and depression are frequently
comorbid (Amiel Castro et al., 2016) and together with stress have been shown to increase
risk for preterm delivery, low birth weight, impaired memory and cognitive function among
others (Talge, Neal & Glover, 2007). The important biopsychological changes brought by the
perinatal period (Ehlert et al., 1990) require constant attention from health workers since
they carry relevant risk factors for the mother's health and for the infant's
neurodevelopment (Schetter & Tanner, 2012).
Current depression interventions are not deliverable to a large number of individuals
(Andersson & Titov, 2014). As seen worldwide, the difficulty to receive proper treatment for
depression and anxiety is also evident in Switzerland. About half of people suffering from
depression and/or anxiety are not diagnosed and consequently do not receive any sort of
psychological or pharmaceutical treatment (Baer et al., 2013).
The internet offers an opportunity to deliver tailored interventions such as those based on
cognitive behavioural therapy (CBT) to a large audience, cost-effectively, while preserving
intervention fidelity and anonymity. The potential effectiveness of the internet is indicated
by research demonstrating the successful delivery of CBT by computer and the use of the
internet in the delivery of CBT treatment (Andrews et al., 2010). Recent reviews of the
evidence have recommended further research that includes long-term follow-up and evaluation
of novel treatment modalities such as the ones provided by internet (Dennis et al., 2012).
Moreover, online interventions have been widely explored for different mental health problems
(Sourander et al., 2016) suggesting its potential to increase access to and uptake of
services for women with a perinatal disorder.
The "Willkommen Mutterglück" program is an 8-session, interactive web-based cognitive
behavioural intervention for prenatal and postpartum depression and anxiety.
Given the prevalence rates of depression and anxiety during the perinatal period and the
rates of untreated patients, it is important to propose treatment alternatives. Several
reviews on the area emphasize that topics such as type and amount of CBT material
incorporated to the program, length and frequency of sessions, amount of homework given and
frequency of minimal therapist intervention are related to effectivity of online
interventions and warrant further research. Also, it is unclear whether therapist contact
focusing on motivation to complete the program is more effective than non-therapist contact
in the treatment of the disorders. Therefore, routine use of this online intervention for
depressed and anxious mothers is only possible if this program/the effects are is
scientifically evaluated with biomarkers.
The primary goal of this project is to investigate the effectiveness of an online cognitive
behavioural intervention specifically tailored to pregnant and postpartum women in reducing
depression and anxiety symptoms. The secondary goal is to assess the feasibility and
usability of this intervention on the treatment of depression and anxiety.
Method: The investigators aim to recruit N=300 patients from the first gestational trimester
to one year after birth. The eight intervention sessions are administered online via audio
and video images. The participants are asked to actively participate during their weekly
session through exercises and quizzes. Each weekly session has a duration of 40-50 minutes.
A SCID interview for screening will be conducted by a trained clinical psychologist and an
experienced psychiatrist from a trusted Outpatient Clinic will verify the diagnosis. Screened
and consented participants will then fill in some baseline questionnaires, provide
sociodemographic information and receive a private login to access the program in order to
start the intervention. After completing the second, fourth and eight intervention session
participants will fill in the same and other psychological questionnaires.
Throughout the intervention, the investigators will frequently monitor patient's progress and
potential worsening of depressive and anxiety symptoms. The investigating team will be
particularly attentive to suicidal ideation. Patients identified with suicidal thoughts will
be immediately contacted by the study team and advised to an appropriate course of action.
Moreover, in all online pages of the "Willkommen Mutterglück" intervention participants can
find an SOS button, providing contact information of emergency psychiatric units and suicide
hotlines.
During the online intervention, participants will be contacted three times by telephone by
coaches (psychotherapists in training). The content of coaching calls will adhere to a
manualized script with defined aims of reviewing patient's progress, problem solving,
encourage skill acquisition and introducing topics in upcoming sessions. Coaches will be
trained with a specific manual developed by the investigation team. Training for the coaching
role will involve reading the coach manual, knowledge of the program content and explanations
from a senior researcher about the role and the tasks involved.
Importance: In view of the substantial challenge posed by the global burden of depression and
anxiety, it is relevant to investigate how a disorder, which is a leading cause of disability
worldwide, may affect mothers and mothers-to-be. Pregnant and postpartum women are often
reluctant to take medication due to concerns about breast milk transmission or potential side
effects. Therefore, non-pharmacologic interventions are a desirable first-line treatment
option for this population. Given that despite frequent interactions with health workers
during pregnancy and postpartum, rates of treatment for perinatal disorders are low, online
therapy may be a viable treatment alternative. The planned longitudinal study is relevant in
investigating the feasibility of an interactive CBT online intervention including minimal
psychotherapist involvement and tailored specifically for this population. At the same time,
it assesses the effectiveness of it in reducing depression and/or anxiety in pregnant and
postpartum women. The results will help to better understand if an intervention (online
program with coaching) with few barriers (e.g. no travel, no childcare costs, reduced
stigma), may serve as an effective treatment option for pregnant and postpartum women who
experience significant stigma or are underresourced in their local community.
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