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Stronger Together: Antenatal Depressive Symptoms - Prevalence and Digital Treatment

Stronger Together: Antenatal Depressive Symptoms - Prevalence and Digital Treatment

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07639164
Enrollment
1000
Registered
2026-06-10
Start date
2026-08-01
Completion date
2030-12-30
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antenatal Depression, Depression / Major Depressive Disorder

Keywords

Digital intervention, Cognitive Behaviour Therapy, Antenatal depression

Brief 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.

Interventions

Digitally delivered CBT intervention with weekly phone coaching

Sponsors

University of Turku
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in the Edinburgh Postnatal Depression Scale (EPDS)Baseline and 11 weeks after baselineEPDS 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.

Secondary

MeasureTime frameDescription
Change in the General Anxiety Disorder 7-item scale (GAD-7)Baseline and 11 weeks after baselineTo 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.
Change in the Beck Depression Inventory II (BDI-II)Baseline and 11 weeks after baselineTo assess the change in depressive symptoms BDI-II will be used.
Social Phobia Inventory (SPIN)Baseline and 11 weeks after baselineTo assess the change in Social Phobia SPIN will be used
Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)Baseline and 11 weeks after baselineTo assess the change in pregnancy related anxiety PRAQ will be used
Perceived Stress Scale (PSS)Baseline and 11 weeks after baselineTo assess the change in perceived stress PSS will be used

Countries

Finland

Contacts

PRINCIPAL_INVESTIGATORAndre Sourander, Professor

Uiniversity of Turku

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026