DepressionNCT04223115
A Randomized Controlled Study of Digitalized Cognitive Behavioral Intervention for Antenatal Depression
A study testing Digitalized CBT with phone coaching and Psychoeducation about depression in people with Depression 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 effectiveness of the digitalized cognitive behavioral therapy program including telephone coaching for antenatal depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Depression, Antenatal Depression
- What is being tested?
- Digitalized CBT with phone coaching and Psychoeducation about depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- 1 siteFinland
- Study dates
- 10 Jun 2021to Dec 2026
- 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
- actively ongoing psychotherapy
- participates in another intervention study aiming at treating the symptoms of antenatal depression
- multiple pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Digitalized Cognitive Behavioral Therapy With Telephone Coaching for Mothers Suffering From Depression During Pregnancy
The main objective of the current research project is to evaluate the effectiveness of the digitalized cognitive behavioral therapy program including telephone coaching for antenatal depressive symptoms. The participants are screened from the general population of pregnant women, as a part of the routine maternity health care check-ups. Mothers with depressive symptoms will be randomized into intervention group receiving guided digitalized treatment program or control group receiving education material about depression in digital form.
- Conditions
- Depression, Antenatal Depression
- Being tested
- Digitalized CBT with phone coaching, Psychoeducation about depression
- Keywords
- digital intervention, cognitive behavioral therapy, antenatal depression
- Medical subject headings
- Depression
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
Psychoeducation about depressionOther
Psychoeducational material about depression in a digitalized form
| Study group | Role | What they receive |
|---|---|---|
| Digitalized CBT intervention with phone coaching | Experimental | Participants receive weekly sessions of internet-based CBT, including telephone coaching Receives: Behavioral: Digitalized CBT with phone coaching |
| Psychoeducation about depression | Active comparator | Participants receive psychoeducative material about depression in digitalized form. Receives: Other: Psychoeducation about depression |
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 randomization
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 randomization
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 randomization
Social Phobia Inventory (SPIN)
To assess the change in Social Phobia SPIN will be used
Measured: Baseline and 11 weeks after randomization
Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)
To assess the change in pregnancy related anxiety PRAQ will be used
Measured: Baseline and 11 weeks after randomization
Perceived Stress Scale (PSS)
To assess the change in perceived stress PSS will be used
Measured: Baseline and 11 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start10 Jun 2021
- Primary completion31 Jul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 634 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, University of Turku, Research Center for Child Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223115
- Sponsor's protocol ID
- DEPMOM-2020
- Status last verified
- May 2026
- First submitted
- 7 Jan 2020
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sourander A, Korpilahti-Leino T, Ristkari T, Koffert T, Arrhenius B, Stahlberg T, Hinkka-Yli-Salomaki S, Berglund M, Upadhyaya S, Wan Mohd Yunus WMA, Sinokki A, Hagg R, Marjamaki A, Kankaanranta I, Palmroth J, Sourander S, Zadkova A, Casagrande L, Yamada Y, Karjalainen S, Matinolli HM, Vuori M. Internet-assisted cognitive behavioral therapy with telephone coaching versus an educational control for antenatal depression: protocol for a randomized controlled trial with population-based screening. Front Psychiatry. 2025 Nov 3;16:1604352. doi: 10.3389/fpsyt.2025.1604352. eCollection 2025.
PubMed 41256941
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Digitalized Cognitive Behavioral Therapy With Telephone Coaching for Mothers Suffering From Depression During Pregnancy
- ClinicalTrials.gov ID
- NCT04223115
- Acronym / sponsor ID
- DEPMOM-2020
- Conditions
- Depression, Antenatal Depression
- Keywords
- digital intervention, cognitive behavioral therapy, antenatal depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 634 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jan 2020 (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 effectiveness of the digitalized cognitive behavioral therapy program including telephone coaching for antenatal depressive symptoms. The participants are screened from the general population of pregnant women, as a part of the routine maternity health care check-ups. Mothers with depressive symptoms will be randomized into intervention group receiving guided digitalized treatment program or control group receiving education material about depression in digital form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digitalized CBT intervention with phone coaching | Experimental | Behavioral: Digitalized CBT with phone coachingParticipants receive weekly sessions of internet-based CBT, including telephone coaching |
| Psychoeducation about depression | Active comparator | Other: Psychoeducation about depressionParticipants receive psychoeducative material about depression in digitalized form. |
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 (6 listed)
- lifetime history of psychotic disorder (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, psychotic depression)
- active suicidal ideation
- severe substance abuse or dependence
- actively ongoing psychotherapy
- 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 | Digitalized CBT intervention with phone coaching |
| Psychoeducation about depressionPsychoeducational material about depression in a digitalized form | Other | Psychoeducation about depression |
Primary outcome
Change in the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Baseline and 11 weeks after randomization
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 randomization
Change in the Beck Depression Inventory II (BDI-II)
Time frame: Baseline and 11 weeks after randomization
Social Phobia Inventory (SPIN)
Time frame: Baseline and 11 weeks after randomization
Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)
Time frame: Baseline and 11 weeks after randomization
Perceived Stress Scale (PSS)
Time frame: Baseline and 11 weeks after randomization
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 15 Jun 2026.
- Derived from this study: PubMed 41256941Sourander A, Korpilahti-Leino T, Ristkari T, Koffert T, Arrhenius B, Stahlberg T, Hinkka-Yli-Salomaki S, Berglund M, Upadhyaya S, Wan Mohd Yunus WMA, Sinokki A, Hagg R, Marjamaki A, Kankaanranta I, Palmroth J, Sourander S, Zadkova A, Casagrande L, Yamada Y, Karjalainen S, Matinolli HM, Vuori M. Internet-assisted cognitive behavioral therapy with telephone coaching versus an educational control for antenatal depression: protocol for a randomized controlled trial with population-based screening. Front Psychiatry. 2025 Nov 3;16:1604352. doi: 10.3389/fpsyt.2025.1604352. eCollection 2025.
- 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. This study is not recruiting at the moment.
Andre Sourander, Professor principal investigator
University of Turku, Research Center for Child Psychiatry
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 and Psychoeducation about depression in people with Depression 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 6 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: under way, not looking for participants, as of the sponsor's last update on 15 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 randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04223115, which also lists 1 linked publication.
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 15 Jun 2026.