Depression / Major Depressive DisorderNCT07639164
Stronger Together: Antenatal Depressive Symptoms - Prevalence and Digital Treatment
A study testing Digitalized CBT with phone coaching in people with Depression / Major Depressive Disorder and Antenatal Depression, run by University of Turku at 1 site in Finland.
Trial summary
The main objective of the current research project is to evaluate the usability, satisfaction of the antenatal iCBT program including telephone coaching for antenatal and postnatal depressive symptoms and collect nationally representative data on population-based screening of antenatal depressive and anxiety symptoms. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Depression / Major Depressive Disorder, Antenatal Depression
- What is being tested?
- Digitalized CBT with phone coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2026to 30 Dec 2030
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- fluent in written and spoken Finnish or Swedish
- access to computer or mobile phone with internet
- between 12 and 22 weeks pregnant
- screening and baseline score on the EPDS ≥10 points
Who cannot join
- lifetime history of psychotic disorder (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, psychotic depression)
- active suicidal ideation
- severe substance abuse or dependence
- participates in another intervention study aiming at treating the symptoms of antenatal depression
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The main objective of the current research project is to evaluate the usability, satisfaction of the antenatal iCBT program including telephone coaching for antenatal and postnatal depressive symptoms and collect nationally representative data on population-based screening of antenatal depressive and anxiety symptoms. The overarching hypothesis is that iCBT, with easy access and affordability, is user friendly and well accepted. In addition to examining the treatment response by questionnaires, we will study the infant development comprehensively as well as potential physiological changes associated with antenatal depression or its treatment.
- Being tested
- Digitalized CBT with phone coaching
- Keywords
- Digital intervention, Cognitive Behaviour Therapy, Antenatal depression
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitalized CBT with phone coachingBehavioural
Digitally delivered CBT intervention with weekly phone coaching
| Study group | Role | What they receive |
|---|---|---|
| CBT Intervention | Experimental | Digitalized CBT intervention with phone coaching Arm Description: Participants receive weekly sessions of internet-based CBT, including telephone coaching Receives: Behavioral: Digitalized CBT with phone coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Edinburgh Postnatal Depression Scale (EPDS)
EPDS is a ten-item self-report questionnaire originally developed to screen for postpartum depression. The respondents are asked about the symptoms of depression. The total score ranges from 0 to 30.
Measured: Baseline and 11 weeks after baseline
Secondary outcomes (5)
Change in the General Anxiety Disorder 7-item scale (GAD-7)
To assess the change in anxiety symptoms from baseline to follow-up, we will use the Generalized Anxiety Disorder 7-item Scale (GAD-7) (Spitzer, Kroenke, Williams, \& Löwe, 2006), which is a brief screening measure including seven items asking about anxiety symptoms experienced in the previous two weeks.
Measured: Baseline and 11 weeks after baseline
Change in the Beck Depression Inventory II (BDI-II)
To assess the change in depressive symptoms BDI-II will be used.
Measured: Baseline and 11 weeks after baseline
Social Phobia Inventory (SPIN)
To assess the change in Social Phobia SPIN will be used
Measured: Baseline and 11 weeks after baseline
Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)
To assess the change in pregnancy related anxiety PRAQ will be used
Measured: Baseline and 11 weeks after baseline
Perceived Stress Scale (PSS)
To assess the change in perceived stress PSS will be used
Measured: Baseline and 11 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression / Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Sourander, University of Turku
- Investigators
- Andre Sourander, Professor, Principal investigator, Uiniversity of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639164
- Sponsor's protocol ID
- DEPMOM-2026
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stronger Together: Antenatal Depressive Symptoms - Prevalence and Digital Treatment
- ClinicalTrials.gov ID
- NCT07639164
- Acronym / sponsor ID
- DEPMOM-2026
- Keywords
- Digital intervention, Cognitive Behaviour Therapy, Antenatal depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 10 Jun 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.
The main objective of the current research project is to evaluate the usability, satisfaction of the antenatal iCBT program including telephone coaching for antenatal and postnatal depressive symptoms and collect nationally representative data on population-based screening of antenatal depressive and anxiety symptoms. The overarching hypothesis is that iCBT, with easy access and affordability, is user friendly and well accepted. In addition to examining the treatment response by questionnaires, we will study the infant development comprehensively as well as potential physiological changes associated with antenatal depression or its treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT Intervention | Experimental | Behavioral: Digitalized CBT with phone coachingDigitalized CBT intervention with phone coaching Arm Description: Participants receive weekly sessions of internet-based CBT, including telephone coaching |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- fluent in written and spoken Finnish or Swedish
- access to computer or mobile phone with internet
- between 12 and 22 weeks pregnant
- screening and baseline score on the EPDS ≥10 points
Key exclusion criteria (4 listed)
- lifetime history of psychotic disorder (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, psychotic depression)
- active suicidal ideation
- severe substance abuse or dependence
- participates in another intervention study aiming at treating the symptoms of antenatal depression
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 |
|---|---|---|
| Digitalized CBT with phone coachingDigitally delivered CBT intervention with weekly phone coaching | Behavioural | CBT Intervention |
Primary outcome
Change in the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Baseline and 11 weeks after baseline
EPDS is a ten-item self-report questionnaire originally developed to screen for postpartum depression. The respondents are asked about the symptoms of depression. The total score ranges from 0 to 30.
5 secondary outcomes
Change in the General Anxiety Disorder 7-item scale (GAD-7)
Time frame: Baseline and 11 weeks after baseline
Change in the Beck Depression Inventory II (BDI-II)
Time frame: Baseline and 11 weeks after baseline
Social Phobia Inventory (SPIN)
Time frame: Baseline and 11 weeks after baseline
Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)
Time frame: Baseline and 11 weeks after baseline
Perceived Stress Scale (PSS)
Time frame: Baseline and 11 weeks after baseline
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 10 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Andre Sourander, Professor principal investigator
Uiniversity of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitalized CBT with phone coaching in people with Depression / Major Depressive Disorder and Antenatal Depression, run by University of Turku at 1 site in Finland.
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: opening soon, as of the sponsor's last update on 10 Jun 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 Finland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Edinburgh Postnatal Depression Scale (EPDS) (time frame: Baseline and 11 weeks after baseline). 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 10 Jun 2026.