About this trial
The purpose of this study is to conduct a feasibility study to test the study procedure and a newly developed self-guided internet-based cognitive behavioral therapy program for mothers with postpartum depression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Edinburgh Postnatal Depression Scale (EPDS) score 11-18
≥age 18
Access to the internet
Disqualifiers
Thoughts of self-harm≥2 on EPDS item 10
Do not understand Danish language,
Substance abuse or dependence
Alcohol abuse, defined as a weekly consumption of alcohol exceeding ten units,
Trial design
Parallel
Treatments tested in this trial
iCARE
DeviceiCARE is an internet-based cognitive behavioral therapy program designed for women experiencing symptoms of postpartum depression, including anxiety, irritability, and sadness. The program offers digital therapy through an online platform tailored to mothers with mild to moderate postpartum depression. The program consists of 7 modules, each with its own theme, incorporating cognitive behavioral therapy, a well-established therapeutic approach for depression. The content includes text, images, audio files, and short films, supplemented with small tasks to provide knowledge and tools to understand and manage one's situation. The treatment course is self-directed, allowing participants to engage with the content at their own pace and at times that are most convenient for them
Treatment groups
Trial outcomes
Primary outcomes
The feasibility of the trial procedure will be assessed as a composite outcome consisting of:
* Data collection feasibility: measured as assessment completion * Recruitment: measured as the total number of eligible participants, the number who completed the screening questionnaire, and the number of participants completing enrollment per month * Experiences with the trial procedures: Post-intervention, all enrolled participants will participate in a semi-structured interview to evaluate their experiences with the trial procedures. A member of the research team will conduct the interviews.
Secondary outcomes
The acceptability of the intervention will be assessed as a composite outcome consisting of:
The acceptability of the intervention will be assessed as a composite outcome consisting of: * The Client Satisfaction Questionnaire (CSQ-8) will measure participants' satisfaction with the intervention. The questionnaire consists of eight items measured on a four-point scale, with total scores ranging from 8 to 32, with a higher number indicating greater satisfaction. * The System Usability Scale (SUS) will measure participants' perceptions of the software's usability. The questionnaire consists of ten items measured on a five-point scale, with total scores ranging from 0 to 100, with a higher number indicating a better outcome. * Experiences using the intervention: Post-intervention, participants in the intervention group will assess their experiences using the intervention and any issues related to it. A research team member will conduct semi-structured interviews with the participants.
Other outcomes
Severity of depressive symptoms
Edinburg Postnatal Depression Scale (EPDS). It is a ten-item questionnaire, with scores ranging from 0 to 30. Higher scores indicate a worse outcome.
Adverse effects of the intervention
Negative Effects Questionnaire (NEQ). The questionnaire includes general information about the possibility of experiencing negative effects and is comprised of three separate parts: 1) "Did you experience this?" (yes/no) 2) "If yes-here is how negatively it affected me" (not at all, slightly, moderately, very, and extremely), and 3) "Probably caused by" (the treatment I received/other circumstances). The questionnaire contains 32 items, and how negatively the negative effect was is measured on a four-point Likert scale, ranging from 0-4 ("0" being minimum and "4" being maximum). Higher scores indicate a worse outcome.
The frequency of occurrence of automatic negative thoughts
The Automatic Thoughts Questionnaire (ATQ). The questionnaire consists of 30 items with a 5-point Likert scale. Scores range from 30 to 150, with higher scores indicating a worse outcome.
Individuals' typical levels of difficulties in emotion regulation
The Difficulties in Emotion Regulation Scale - 16-item version (DERS-16). The questionnaire consists of 16 items that assess emotion regulation difficulties. The total score ranges from 16 to 80, with higher scores indicating more difficulties with emotion regulation.
Locations
Sponsors and contacts
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University of Southern Denmark
Lead sponsor
Region of Southern Denmark
Collaborator
University of Copenhagen
Collaborator
University of Aarhus
Collaborator
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