Feasibility Study: Self-guided iCBT for Mothers With Postpartum Depression.
NCT Number: NCT06569875
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postpartum Depression|Internet-based Intervention
Interventions: DEVICE: iCARE
Sponsor: University of Southern Denmark
Collaborators: Region of Southern Denmark|University of Copenhagen|University of Aarhus
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-10-30

Summary:
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.

Primary Outcome Measures: 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., Baseline, two-month follow-up, and the six-month follow-up
Secondary Outcome Measures: 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., Two-month follow-up
Other Outcome Measures: 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., Baseline, two-month follow-up, and the six-month follow-up|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., Two-month follow-up|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., Two-month follow-up|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., Two-month follow-up|Level of stress associated with raising children, Danish Parental Stress Scale (DPSS). This is an 18-item measure of parental stress rated on a five-point scale (Strongly disagree, Disagree, Undecided, Agree, Strongly agree). The total score range is from 18 to 90, and a low score indicates less stress., Two-month follow-up|The social-emotional development of children, The Ages and Stages Questionnaire Social-Emotional Six Month (ASQ-SE-2): The questionnaire comprises 23 scored items with higher scores indicating a worse outcome., Two-month follow-up|Disability/functioning, World Health Organization disability assessment schedule 2.0 12 items: The questionnaire consists of 12 items, measured by a 5-point scale, with scores ranging from 12 to 60. Higher scores indicate a worse outcome., Baseline, two-month follow-up, and the six-month follow-up|levels of anxiety, Generalized Anxiety Disorder Assessment (GAD-7): This questionnaire screens levels of anxiety and consists of 7 items scored on a 0-3 scale from 0 to 21. Higher scores indicate a worse outcome., Baseline, two-month follow-up, and the six-month follow-up