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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Antenatal Depression
• Intervention / Treatment: Behavioral: Digitalized CBT with phone coaching; Other: Psychoeducation about depression

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mari Berglund; Phone Number: +358 504427185; Email: mari.berglund@utu.fi
• Study Contact Backup: Name: Tiia Ståhlberg; Phone Number: 0504381160; Email: tthuht@utu.fi

Study Locations

• Finland
  • Turku, Finland
    • Recruiting
    • University of Turku
    • Contact: Mari Berglund; Phone Number: +358 504427185; Email: mari.berglund@utu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digitalized CBT intervention with phone coaching; Participants receive weekly sessions of internet-based CBT, including telephone coaching	Behavioral: Digitalized CBT with phone coaching; Digitally delivered CBT intervention with weekly phone coaching
Active Comparator: Psychoeducation about depression; Participants receive psychoeducative material about depression in digitalized form.	Other: Psychoeducation about depression; Psychoeducational material about depression in a digitalized form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Turku
• Investigators: Principal Investigator: Andre Sourander, Professor, University of Turku, Research Center for Child Psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; digital intervention; antenatal depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: DEPMOM-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No