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Clinical Trials/NCT04183946
NCT04183946UnknownNot Applicable

Willkommen Mutterglück: A Controlled Trial of Internet Based Cognitive Behavioural Therapy (CBT) for Pregnant and Postpartum Women With Depression and Anxiety

University of Zurich1 site in 1 country300 target enrollmentStarted: June 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
300
Locations
1
Primary Endpoint
Change of depressive symptoms at four measuring points from baseline to follow up

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •pregnant women or women who had given birth in the last year
  • •between 18 and 45 years old
  • •minor to moderate depression and/or generalised anxiety disorder
  • •fluent in German
  • •having a computer, laptop or handheld device with internet access

Exclusion Criteria

  • •women with a severe medical disorder or a severe psychological disorder such as psychosis, drug addiction and other substance abuse
  • •women taking psychotropic medication
  • •women with current suicidality
  • •women who are currently receiving psychological treatment for depression or anxiety

Arms & Interventions

Online Cognitive Behavioural Therapy

Other

Screened participants diagnosed with minor to moderate anxiety and/or depression will receive online CBT therapy (8 interactive sessions) aiming to treat their symptomatology. Each session can be completed at one's own pace.

Intervention: Online Cognitive Behavioural Therapy (Behavioral)

Outcomes

Primary Outcomes

Change of depressive symptoms at four measuring points from baseline to follow up

Time Frame: At baseline, during week 4, 8, 16 of the intervention and at one month after completing intervention.

Measured with Beck's Depression Inventory (BDI)

Change of anxiety symptoms at four measuring points from baseline to follow up

Time Frame: At baseline, during week 4, 8, 16 of the intervention and at one month after completing intervention.

Measured with Beck's Anxiety Inventory (BAI)

Change of depression symptoms from baseline until follow-up

Time Frame: At baseline and during week 16 of the intervention

Measured with Edinburgh Postnatal Depression Scale (EPDS) Minimum score = 0, maximum score = 30. Cut off value is set at 12/13

Change of severity of depressive symptoms at four measuring points from baseline to follow up

Time Frame: At baseline, during week 4, 8, 16 of the intervention and at one month after completing intervention.

Measured with Patient Health Questionnaire (PHQ) Ranges from 0-27 (0-4=none-minimal; 5-9=mild; 10-14=moderate; 15-19=moderately severe; 20-27=severe)

Secondary Outcomes

  • Participant's satisfaction with the program and it's usability(At week 16 of the intervention)
  • Program's evaluation of feasibility with prenatal and postpartum women(From baseline until 1 month follow-up of the intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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