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

Randomized Controlled Trial of Digitalized Cognitive Behavioral Therapy With Telephone Coaching for Mothers Suffering From Depression During Pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04223115
Enrollment
634
Registered
2020-01-10
Start date
2021-06-10
Completion date
2026-12-01
Last updated
2026-06-15

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

Conditions

Antenatal Depression, Depression

Keywords

digital intervention, cognitive behavioral therapy, antenatal depression

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.

Interventions

Digitally delivered CBT intervention with weekly phone coaching

OTHERPsychoeducation about depression

Psychoeducational material about depression in a digitalized form

Sponsors

University of Turku
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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 * actively ongoing psychotherapy * participates in another intervention study aiming at treating the symptoms of antenatal depression * multiple pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Change in the Edinburgh Postnatal Depression Scale (EPDS)Baseline and 11 weeks after randomizationEPDS 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 randomizationTo 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 randomizationTo assess the change in depressive symptoms BDI-II will be used.
Social Phobia Inventory (SPIN)Baseline and 11 weeks after randomizationTo assess the change in Social Phobia SPIN will be used
Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)Baseline and 11 weeks after randomizationTo assess the change in pregnancy related anxiety PRAQ will be used
Perceived Stress Scale (PSS)Baseline and 11 weeks after randomizationTo assess the change in perceived stress PSS will be used

Countries

Finland

Contacts

PRINCIPAL_INVESTIGATORAndre Sourander, Professor

University of Turku, Research Center for Child Psychiatry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026