Actively Recruiting
Evaluating the Effectiveness of an Internet-based Therapy (iCARE) to Treat Symptoms of Postpartum Depression
Led by University of Southern Denmark · Updated on 2026-02-05
352
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Southern Denmark
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Postpartum depression (PPD) is a common and serious condition affecting women after childbirth, characterized by symptoms like low mood, loss of interest, and impaired functioning. This trial evaluates whether adding an internet-based cognitive behavioral therapy (iCBT) program with Acceptance and Commitment Therapy (ACT) elements, called iCARE, to usual treatment can better reduce depressive symptoms in mothers with PPD in Denmark. The study also includes a qualitative process evaluation to understand participant experiences and factors affecting the intervention's impact. The iCARE program is a self-guided online therapy consisting of four core modules focused on self-care, mindfulness, self-compassion, positive experiences, and challenging negative thinking. Four optional modules offer additional support for presence, communication, bonding with the baby, and coping with difficult thoughts. Participants are randomly assigned to receive either iCARE alongside treatment as usual (TAU) or TAU alone. TAU varies by municipality and may include psychological support, follow-up by health nurses, general practitioner visits, antidepressants, or private psychologist services. Women in the study will be assessed at baseline, 2 months, and 6 months for postpartum depression symptoms, anxiety, health-related functioning, negative thoughts, and parental stress. Researchers will collect data through questionnaires and evaluate how well participants engage with the program. The total duration of participation covers these timepoints, with safety and acceptability monitored throughout. This approach aims to provide flexible, accessible support for mothers facing PPD.
CONDITIONS
Brief Title
Evaluating the Effectiveness of an Internet-based Therapy (iCARE) to Treat Symptoms of Postpartum Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Given birth within 6 months
- Edinburgh Postnatal Depression Scale (EPDS) score above 7
- Age 18 or older
- Access to the internet
You will not qualify if you...
- Do not understand Danish language
- Substance abuse or dependence
- Alcohol abuse, defined by a weekly consumption of alcohol exceeding 10 units
- Diagnosis of schizophrenia, other psychotic disorders, or immediate need of psychiatric treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 months
Participants engage in self-guided internet-based therapy (iCARE) combined with treatment as usual or receive treatment as usual alone to address symptoms of postpartum depression.
Regular online participation during the 2-month treatment period
Duration - 4 months
Participants are monitored for ongoing symptoms of postpartum depression, anxiety, health-related disability, and parental stress after completing the treatment period.
Assessments conducted at 6 months after treatment start
Trial Site Locations
Total: 1 location
1
Research Unit of Child and Adolescent Psychiatry, Department of Clinical Research, University of Southern Denmark
Odense, Denmark, 5250
Actively Recruiting
Research Team
T
Trine Munk-Olsen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here