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

NCT07384273 | Recruiting

• 4 other identifiers: 16-0302-2323/1532712.250514-1114/25-3000
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression (PPD)

Keywords

Postpartum depression; Cognitive behavioural therapy; Internet-based therapy; Acceptance and commitment therapy; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Symptoms of postpartum depression

  The Edinburgh Postnatal Depression Scale (EPDS) is a validated screening questionnaire that measures symptoms of postnatal depression, such as low mood, anxiety, and loss of enjoyment, over the past week. It helps identify mothers who may need further assessment or support but does not provide a diagnosis. The primary outcome is the between-group difference in change from baseline to 2-month follow-up in EPDS score (range 0-30; higher scores indicate more severe symptoms). A clinically meaningful response is defined as a ≥3-point reduction from baseline. Participants will be categorized as responders/non-responders, and proportions will be reported for each group.

  Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)

Secondary Outcomes (4)

• Symptoms of anxiety

  Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)

• Health-related disability and functioning

  Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)

• Automatic negative thoughts/negative self-statements

  At 2-months (primary endpoint)

• Parental Stress

  At 2-months (primary endpoint)

Study Arms (2)

Internet-based therapy (iCARE) and treatment as usual

EXPERIMENTAL

The iCARE program is a self-guided iCBT intervention that also incorporates selected exercises and approaches from ACT. The iCARE program consists of four core modules and four optional modules. Together, these exercises aim to enhance psychological flexibility, reduce negative thinking, and promote well-being in daily life. The core modules focus on self-care and mindfulness (Module 1), identifying and reframing unrealistic expectations with self-compassion (Module 2), increasing positive experiences and countering self-critical thoughts (Module 3), and recognizing and challenging thinking traps (Module 4). The additional optional modules provide strategies for practicing being present, communicating needs and asking for support, bonding with the baby, and coping with scary thoughts.

Behavioral: Internet-based therapy (iCARE) and treatment as usual

Treatment as usual

ACTIVE COMPARATOR

In Denmark, there is large variation in the available prevention and treatment municipalities offers for women experiencing symptoms of PPD. Some municipalities offer specialized psychological support and support groups, while others provide only basic follow-up by health nurses. Women can also be referred to their general practitioner, who can provide free ongoing follow-up and prescribe antidepressant medication if needed. Alternatively, it is possible to be referred to a privately practicing psychologist, usually with some out-of-pocket cost.

Other: Treatment as usual (TAU)

Interventions

Internet-based therapy (iCARE) and treatment as usual BEHAVIORAL

The iCARE program is a self-guided iCBT intervention that also incorporates selected exercises and approaches from ACT. The iCARE program consists of four core modules and four optional modules. Together, these exercises aim to enhance psychological flexibility, reduce negative thinking, and promote well-being in daily life. The core modules focus on self-care and mindfulness (Module 1), identifying and reframing unrealistic expectations with self-compassion (Module 2), increasing positive experiences and countering self-critical thoughts (Module 3), and recognizing and challenging thinking traps (Module 4). The additional optional modules provide strategies for practicing being present, communicating needs and asking for support, bonding with the baby, and coping with scary thoughts.

Internet-based therapy (iCARE) and treatment as usual

Treatment as usual (TAU) OTHER

In Denmark, there is large variation in the available prevention and treatment municipalities offers for women experiencing symptoms of PPD. Some municipalities offer specialized psychological support and support groups, while others provide only basic follow-up by health nurses. Women can also be referred to their general practitioner, who can provide free ongoing follow-up and prescribe antidepressant medication if needed. Alternatively, it is possible to be referred to a privately practicing psychologist, usually with some out-of-pocket cost.

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Given birth within 6 months
• Edinburgh Postnatal Depression Scale (EPDS) score above 7
• ≥age 18
• Access to the internet

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead
• University of Copenhagen: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Research Unit of Child and Adolescent Psychiatry, Department of Clinical Research, University of Southern Denmark

Odense, 5250, Denmark

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Trine Munk-Olsen, PhD

CONTACT

+4524466297; tmun@sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Superiority, two-arm, randomised controlled trial

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 3, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

DK (1)