Feasibility Study: Self-guided iCBT for Mothers With Postpartum Depression.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Southern Denmark

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • iCARE

    Device

    iCARE 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

20 Participants
are divided into 2 treatment groups
Group A: Internet-based cognitive behavioural therapy programExperimental treatment 1 intervention
Group B: Treatment as usualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, two-month follow-up, and the six-month follow-up

Secondary outcomes

1

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.

Time frame
Two-month follow-up

Other outcomes

1

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.

Time frame
Baseline, two-month follow-up, and the six-month follow-up
2

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.

Time frame
Two-month follow-up
3

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.

Time frame
Two-month follow-up
4

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.

Time frame
Two-month follow-up

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern Denmark

Lead sponsor

Region of Southern Denmark

Collaborator

University of Copenhagen

Collaborator

University of Aarhus

Collaborator

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