Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07384273

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Evaluating the Effectiveness of an Internet-based Therapy (iCARE) to Treat Symptoms of Postpartum Depression | DecenTrialz