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

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression (PPD)
• Intervention / Treatment: Behavioral: Internet-based therapy (iCARE) and treatment as usual; Other: Treatment as usual (TAU)

• Study Type: Interventional
• Enrollment (Estimated): 352
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trine Munk-Olsen, PhD; Phone Number: +4524466297; Email: tmun@sdu.dk

Study Locations

• Denmark
  • Odense, Denmark, 5250
    • Recruiting
    • Research Unit of Child and Adolescent Psychiatry, Department of Clinical Research, University of Southern Denmark
    • Contact: Trine Munk-Olsen, PhD; Phone Number: +4524466297; Email: tmun@sdu.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based therapy (iCARE) and treatment as usual; 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; 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.
Active Comparator: Treatment as usual; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of anxiety	The Generalized Anxiety Disorder assessment (GAD-7) is a validated self-report questionnaire designed to assess symptoms of generalized anxiety disorder and overall anxiety severity. It consists of seven items scored from 0 (not at all) to 3 (nearly every day), producing a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptoms. While the GAD-7 was originally developed to measure Generalized Anxiety Disorder, it has also been validated as a general measure of symptom severity of anxiety across different anxiety disorders in heterogeneous samples. In this trial, changes in GAD-7 scores from baseline to 2 and 6 months will indicate whether the intervention reduces anxiety symptoms.	Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)
Health-related disability and functioning	World Health Organization Disability Assessment Schedule (WHODAS 2.0) is a generic, internationally validated tool for assessing health-related disability and functioning. The 12-item version used here provides a total score from 0 (no disability) to 48 (severe disability). It captures the broader impact of mental health symptoms on daily functioning and quality of life. Changes from baseline to 2 and 6 months will help determine whether iCARE improves overall functioning beyond symptom reduction.	Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)
Parental Stress	The Danish Parental Stress Scale (DPSS) measures stress related to parenting responsibilities. It consists of 18 items rated on a 5-point scale, with total scores ranging from 18 (low stress) to 90 (high stress). Assessing DPSS at 2 months will help determine whether the intervention reduces stress associated with caring for an infant.	At 2-months (primary endpoint)
Automatic negative thoughts/negative self-statements	The Automatic Thoughts Questionnaire (ATQ) measures the frequency of automatic negative thoughts (negative self-statements). The shortened 8 item version will be used. It includes 8 items rated on a 5-point Likert scale, assessing thoughts such as self-criticism, hopelessness, and personal failure. Scores range from 0 (few negative thoughts) to 32 (frequent negative thoughts). Evaluating between-group differences in ATQ at 2 months follow-up will indicate whether the intervention effectively targets maladaptive thinking patterns.	At 2-months (primary endpoint)

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Odense University Hospital; University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Randomised controlled trial; Cognitive behavioural therapy; Postpartum depression; Acceptance and commitment therapy; Internet-based therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum; Therapeutics
• Other Study ID Numbers: 16-0302-23 (Other Identifier: The Danish Health Research Ethics Committee); 12.250 (Other Identifier: University of Southern Denmark); 23/15327 (Other Identifier: Region of Southern Denmark); 514-1114/25-3000 (Other Identifier: Copenhagen University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual de-identified participant data will be stored in (Open Patient data Explorative Network) and access might be available for affiliated researchers under data governance and approvals. The code will be available from the corresponding author on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No