Willkommen Mutterglück: Online CBT for Pregnant and Postpartum Women With Depression and Anxiety

November 28, 2019 updated by: University of Zurich

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8050
        • University of Zurich, Department of Psychology - Clinical Psychology and Psychotherapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Online Cognitive Behavioural Therapy
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.
Behavioral: Online Cognitive Behavioural Therapy

The "Willkommen Mutterglück" program is an 8-session, interactive web-based CBT intervention for prenatal and postpartum depression and anxiety. The sessions are administered online via audio and video images. Each weekly session has a duration of 40-50 minutes during which the participants are asked to actively participate through exercises and quizzes.

A SCID interview for screening will be conducted by a trained clinical psychologist and an experienced psychiatrist from our outpatient clinic will verify the diagnosis. Screened and consented participants will answer baseline questionnaires, provide sociodemographic information and receive a private login to access the program. After completing the 2nd, 4th and 8th intervention session participants will fill in psychological questionnaires.

During the intervention, participants will be contacted three times by telephone by coaches (psychotherapists in training) who follow a manualized script.

Other Names:
  • Willkommen Mutterglück: Online CBT program for pre-postnatal depression & anxiety

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant's satisfaction with the program and it's usability
Time Frame: At week 16 of the intervention
This is reported with open-ended questions about satisfaction with the program and with self-report measure that assesses the patient's attitude on the overall usability to the program (System Usability Scale, SUS) The scores range from 0-100. It is agreed that score above 68 would be considered above average, whilst scores below 68 would be considered below average.
At week 16 of the intervention
Program's evaluation of feasibility with prenatal and postpartum women
Time Frame: From baseline until 1 month follow-up of the intervention
This is reported with user engagement, such as duration spent on web-intervention-site and number of log-ins into the intervention. These different measures should give an overview over how the participants perceive and evaluate the program and how they rate its feasibility.
From baseline until 1 month follow-up of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Ambulatorium für kognitive Verhaltenstherapie und Verhaltensmedizin - UZH
Lamprecht AG

Investigators

  • Study Chair: Ulrike Ehlert, Prof. Dr., University of Zurich, Department of Psychology - Clinical Psychology and Psychotherapy
  • Principal Investigator: Rita Amiel Castro, Dr. phil., University of Zurich, Department of Psychology - Clinical Psychology and Psychotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

November 28, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

November 28, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Willkommen Mutterglück Program

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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