NCT07384273 Evaluating the Effectiveness of an Internet-based Therapy (iCARE) to Treat Symptoms of Postpartum Depression
| NCT ID | NCT07384273 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Southern Denmark |
| Condition | Postpartum Depression (PPD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 352 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 352 participants in total. It began in 2026-02-01 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Given birth within 6 months * Edinburgh Postnatal Depression Scale (EPDS) score above 7 * ≥age 18 * Access to the internet Exclusion Criteria: * Do not understand Danish language, * Substance abuse or dependence * Alcohol abuse, defined by a weekly consumption of alcohol exceeding 10 units * A diagnosis of schizophrenia, other psychotic disorders or in immediate need of psychiatric treatment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07384273 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postpartum Depression (PPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07384273 currently recruiting?
Yes, NCT07384273 is actively recruiting participants. Contact the research team at tmun@sdu.dk for enrollment information.
Where is the NCT07384273 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT07384273 clinical trial?
NCT07384273 is sponsored by University of Southern Denmark. The trial plans to enroll 352 participants.
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