Stronger Together: Antenatal Depressive Symptoms - Prevalence and Digital Treatment

NCT07639164 | Not Yet Recruiting

• 1 other identifier: DEPMOM-2026
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Antenatal Depression; Depression / Major Depressive Disorder

Keywords

Digital intervention; Cognitive Behaviour Therapy; Antenatal depression

Outcome Measures

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.

  Baseline and 11 weeks after baseline

Secondary Outcomes (5)

• Change in the General Anxiety Disorder 7-item scale (GAD-7)

  Baseline and 11 weeks after baseline

• Change in the Beck Depression Inventory II (BDI-II)

  Baseline and 11 weeks after baseline

• Social Phobia Inventory (SPIN)

  Baseline and 11 weeks after baseline

• Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)

  Baseline and 11 weeks after baseline

• Perceived Stress Scale (PSS)

  Baseline and 11 weeks after baseline

Study Arms (1)

CBT Intervention

EXPERIMENTAL

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

Digitalized CBT with phone coaching BEHAVIORAL

Digitally delivered CBT intervention with weekly phone coaching

CBT Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turku: lead

Study Sites (1)

University of Turku

Turku, Finland

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Andre Sourander, Professor

  Uiniversity of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)