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

Not Applicable

Recruiting

• Conditions: Antenatal Depression; Depression
• Interventions: Behavioral: Digitalized CBT with phone coaching; Other: Psychoeducation about depression

• Registration Number: NCT04223115
• Lead Sponsor: University of Turku

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-10
• Study Start: 2021-06-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 634

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digitalized CBT intervention with phone coaching	Digitalized CBT with phone coaching	Participants receive weekly sessions of internet-based CBT, including telephone coaching
Psychoeducation about depression	Psychoeducation about depression	Participants receive psychoeducative material about depression in digitalized form.

Primary Outcome Measures

Name	Time	Method
Change in the Edinburgh Postnatal Depression Scale (EPDS)	Baseline and 11 weeks after randomization	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Turku; 🇫🇮 Turku, Finland