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Active, not recruitingNCT04223115Updated Jun 15, 2026

A Randomized Controlled Study of Digitalized Cognitive Behavioral Intervention for Antenatal Depression

An interventional study of Digitalized CBT with phone coaching and Psychoeducation about depression in Depression and Antenatal Depression, sponsored by University of Turku. Active, not recruiting at 1 site in Finland. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by University of Turku · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
634
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Depression
  • Antenatal Depression

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Keywords

  • digital intervention
  • cognitive behavioral therapy
  • antenatal depression
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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 634 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Turku is the lead sponsor of 122 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
634 participants (estimated)

Study arms

  • Experimental
    Digitalized CBT intervention with phone coaching

    Participants receive weekly sessions of internet-based CBT, including telephone coaching

    Behavioral: Digitalized CBT with phone coaching

  • Active comparator
    Psychoeducation about depression

    Participants receive psychoeducative material about depression in digitalized form.

    Other: Psychoeducation about depression

Interventions

  • BehavioralDigitalized CBT with phone coaching

    Digitally delivered CBT intervention with weekly phone coaching

  • OtherPsychoeducation about depression

    Psychoeducational material about depression in a digitalized form

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 11 weeks after randomization

Secondary outcomes

  1. 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.

    Time frame: Baseline and 11 weeks after randomization

  2. Change in the Beck Depression Inventory II (BDI-II)

    To assess the change in depressive symptoms BDI-II will be used.

    Time frame: Baseline and 11 weeks after randomization

  3. Social Phobia Inventory (SPIN)

    To assess the change in Social Phobia SPIN will be used

    Time frame: Baseline and 11 weeks after randomization

  4. Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)

    To assess the change in pregnancy related anxiety PRAQ will be used

    Time frame: Baseline and 11 weeks after randomization

  5. Perceived Stress Scale (PSS)

    To assess the change in perceived stress PSS will be used

    Time frame: Baseline and 11 weeks after randomization

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Study locations

1 site
  • University of Turku
    Turku, Finland
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04223115
Lead sponsor
University of Turku
Responsible party
Andre Sourander (Professor, Child Psychiatry, University of Turku) — Principal investigator
First posted
Jan 10, 2020
Start date
Jun 10, 2021
Primary completion
Jul 31, 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 15, 2026

Study contacts

Andre Sourander, Professor
principal investigator · University of Turku, Research Center for Child Psychiatry

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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