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Not yet recruitingNCT07639164Updated Jun 10, 2026

Stronger Together: Antenatal Depressive Symptoms - Prevalence and Digital Treatment

An interventional study of Digitalized CBT with phone coaching in Depression / Major Depressive Disorder and Antenatal Depression, sponsored by University of Turku. Not yet recruiting at 1 site in Finland. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-10.

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

Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Depression / Major Depressive Disorder
  • Antenatal Depression

Keywords

  • Digital intervention
  • Cognitive Behaviour Therapy
  • Antenatal depression
03

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
  • participates in another intervention study aiming at treating the symptoms of antenatal depression
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    CBT Intervention

    Digitalized CBT intervention with phone coaching Arm Description: Participants receive weekly sessions of internet-based CBT, including telephone coaching

    Behavioral: Digitalized CBT with phone coaching

Interventions

  • BehavioralDigitalized CBT with phone coaching

    Digitally delivered CBT intervention with weekly phone coaching

05

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 baseline

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 baseline

  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 baseline

  3. Social Phobia Inventory (SPIN)

    To assess the change in Social Phobia SPIN will be used

    Time frame: Baseline and 11 weeks after baseline

  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 baseline

  5. Perceived Stress Scale (PSS)

    To assess the change in perceived stress PSS will be used

    Time frame: Baseline and 11 weeks after baseline

06

Study locations

1 site
  • University of Turku
    Turku, Finland
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07639164
Lead sponsor
University of Turku
Responsible party
Andre Sourander (Professor, University of Turku) — Principal investigator
First posted
Jun 10, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Dec 30, 2030 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
Jun 10, 2026

Study contacts

Andre Sourander, Professor
principal investigator · Uiniversity of Turku

Oversight

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

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

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