Postpartum Depression (PPD)iCARENCT07384273
Evaluating the Effectiveness of an Internet-based Therapy (iCARE) to Treat Symptoms of Postpartum Depression
A study testing Internet-based therapy (iCARE) and treatment as usual and Treatment as usual (TAU) in people with Postpartum Depression (PPD), run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression (PPD)
- What is being tested?
- Internet-based therapy (iCARE) and treatment as usual and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Given birth within 6 months
- Edinburgh Postnatal Depression Scale (EPDS) score above 7
- ≥age 18
- Access to the internet
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Research Unit of Child and Adolescent Psychiatry, Department of Clinical Research, University of Southern Denmark
Odense, 5250
Trine Munk-Olsen, PhD, +4524466297, tmun@sdu.dk
About this study
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.
Read more
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)
- Being tested
- Internet-based therapy (iCARE) and treatment as usual, Treatment as usual (TAU)
- Keywords
- Postpartum depression, Cognitive behavioural therapy, Internet-based therapy, Acceptance and commitment therapy, Randomised controlled trial
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based therapy (iCARE) and treatment as usualBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)
Secondary outcomes (4)
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.
Measured: 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.
Measured: Baseline At 2 months (primary endpoint) At 6 months (secondary 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.
Measured: At 2-months (primary 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.
Measured: At 2-months (primary endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Feb 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Superiority, two-arm, randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Odense University Hospital
- Responsible party
- Principal investigator, Trine Munk-Olsen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384273
- Sponsor's protocol ID
- 16-0302-23
- Other IDs
- 23/15327, 12.250, 514-1114/25-3000, 16-0302-23
- Acronym
- iCARE
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of an Internet-based Therapy (iCARE) to Treat Symptoms of Postpartum Depression
- ClinicalTrials.gov ID
- NCT07384273
- Acronym / sponsor ID
- iCARE / 16-0302-23
- Conditions
- Postpartum Depression (PPD)
- Keywords
- Postpartum depression, Cognitive behavioural therapy, Internet-based therapy, Acceptance and commitment therapy, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Copenhagen, Odense University Hospital
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Superiority, two-arm, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Internet-based therapy (iCARE) and treatment as usual | Experimental | Behavioral: Internet-based therapy (iCARE) and treatment as usualThe 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. |
| Treatment as usual | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Given birth within 6 months
- Edinburgh Postnatal Depression Scale (EPDS) score above 7
- ≥age 18
- Access to the internet
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based therapy (iCARE) and treatment as usualThe 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. | Behavioural | Internet-based therapy (iCARE) and treatment as usual |
| 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. | Other | Treatment as usual |
Primary outcome
Symptoms of postpartum depression
Time frame: Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)
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.
4 secondary outcomes
Symptoms of anxiety
Time frame: Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)
Health-related disability and functioning
Time frame: Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)
Automatic negative thoughts/negative self-statements
Time frame: At 2-months (primary endpoint)
Parental Stress
Time frame: At 2-months (primary endpoint)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based therapy (iCARE) and treatment as usual and Treatment as usual (TAU) in people with Postpartum Depression (PPD), run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trine Munk-Olsen, PhD (+4524466297, tmun@sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of postpartum depression (time frame: Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.