NCT04223115

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
634

participants targeted

Target at P75+ for not_applicable depression

Timeline
1mo left

Started Jun 2021

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2021Jun 2026

First Submitted

Initial submission to the registry

January 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

4.5 years

First QC Date

January 7, 2020

Last Update Submit

November 22, 2024

Conditions

DepressionAntenatal Depression

Keywords

digital interventioncognitive behavioral therapyantenatal 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 randomization

Secondary Outcomes (5)

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

    Baseline and 11 weeks after randomization

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

    Baseline and 11 weeks after randomization

  • Social Phobia Inventory (SPIN)

    Baseline and 11 weeks after randomization

  • Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)

    Baseline and 11 weeks after randomization

  • Perceived Stress Scale (PSS)

    Baseline and 11 weeks after randomization

Study Arms (2)

Digitalized CBT intervention with phone coaching

EXPERIMENTAL

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

Behavioral: Digitalized CBT with phone coaching

Psychoeducation about depression

ACTIVE COMPARATOR

Participants receive psychoeducative material about depression in digitalized form.

Other: Psychoeducation about depression

Interventions

Digitalized CBT with phone coachingBEHAVIORAL

Digitally delivered CBT intervention with weekly phone coaching

Digitalized CBT intervention with phone coaching
Psychoeducation about depressionOTHER

Psychoeducational material about depression in a digitalized form

Psychoeducation about depression

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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
  • actively ongoing psychotherapy
  • participates in another intervention study aiming at treating the symptoms of antenatal depression
  • multiple pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turku

Turku, Finland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41256941DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Andre Sourander, Professor

    University of Turku, Research Center for Child Psychiatry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mari Berglund

CONTACT

+358 504427185mari.berglund@utu.fi

Tiia Ståhlberg

CONTACT

0504381160tthuht@utu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Child Psychiatry

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 10, 2020

Study Start

June 10, 2021

Primary Completion

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)