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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04223115
Other study ID # DEPMOM-2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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