Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID07384273

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

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 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 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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

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

Follow-up

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

Loading map...

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

A Mobile Application for Early Detection and Symptoms Trajec...

Postpartum Depression (PPD)

Actively Recruiting

1 location

A Prospective Validation of the Enlighten Device in Predicti...

Postpartum Depression (PPD)

Actively Recruiting

1 location

Clinical Validation of a Predictive Test for Postpartum Depr...

Postpartum Depression (PPD)

Actively Recruiting

2 locations

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