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
130 weeks
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 9.5% of women in high-income countries, and around 8% in Denmark. It shares core features with major depression, including low mood, loss of interest, and impaired functioning. Untreated PPD can persist for months, negatively impacting maternal well-being, child development, and family dynamics. In Denmark, systematic screening using the Edinburgh Postnatal Depression Scale (EPDS) is standard practice, but access to PPD treatment varies widely across municipalities. Cognitive behavioral therapy (CBT) is the most effective psychological intervention for perinatal depression, yet limited availability and long wait times create barriers to access to care. Internet-based CBT (iCBT) offers a scalable, cost-effective alternative that can be delivered flexibly at home. Evidence supports the efficacy of self-guided iCBT for depression, though challenges such as high dropout rates have been reported. International trials in Norway, Portugal, Iran, South Korea, and the US have shown promising results for iCBT in perinatal populations. Some recent iCBT based interventions have also incorporated elements of Acceptance and Commitment Therapy (ACT) - which emphasizes psychological flexibility via mindfulness-based acceptance and values-driven action-and have demonstrated efficacy in reducing postpartum depression symptoms. These kinds of interventions (either iCBT or iCBT + ACT) have not yet been tested and evaluated in Denmark. This clinical trial aims to evaluate whether adding an iCBT intervention with elements from ACT (iCARE) to treatment as usual (TAU) is more effective than TAU alone in reducing depressive symptoms in mothers with symptoms of PPD. Moreover, a qualitative process evaluation of the iCARE will explore implementation, acceptability, and mechanisms of impact. Its primary aim is to understand how participants experience the iCARE intervention and TAU, focusing on implementation fidelity, acceptability, and contextual influences. The secondary aim is to explore perceived mechanisms of change (e.g., cognitive, emotional, behavioral) and barriers/facilitators to engagement.
CONDITIONS
Official 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 years or older
- Access to the internet
You will not qualify if you...
- Do not understand Danish language
- Substance abuse or dependence
- Alcohol abuse defined as weekly consumption exceeding 10 units
- Diagnosis of schizophrenia, other psychotic disorders, or immediate need of psychiatric treatment
AI-Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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