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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04223115
• Other study ID #: DEPMOM-2020
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: June 2026

Study information

• Verified date: February 2024
• Source: University of Turku
• Contact: Mari Berglund
• Phone: +358 504427185
• Email: mari.berglund[@]utu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Antenatal Depression
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Digitalized CBT with phone coaching
Digitally delivered CBT intervention with weekly phone coaching

Other:
• Psychoeducation about depression
Psychoeducational material about depression in a digitalized form

Locations

Country	Name	City	State
Finland	University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Social Phobia Inventory (SPIN)	To assess the change in Social Phobia SPIN will be used	Baseline and 11 weeks after randomization
Secondary	Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)	To assess the change in pregnancy related anxiety PRAQ will be used	Baseline and 11 weeks after randomization
Secondary	Perceived Stress Scale (PSS)	To assess the change in perceived stress PSS will be used	Baseline and 11 weeks after randomization