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

NCT ID: NCT04223115

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

634 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Depression Antenatal Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Digitalized CBT intervention with phone coaching

Participants receive weekly sessions of internet-based CBT, including telephone coaching

Group Type EXPERIMENTAL

Digitalized CBT with phone coaching

Intervention Type BEHAVIORAL

Digitally delivered CBT intervention with weekly phone coaching

Psychoeducation about depression

Participants receive psychoeducative material about depression in digitalized form.

Group Type ACTIVE_COMPARATOR

Psychoeducation about depression

Intervention Type OTHER

Psychoeducational material about depression in a digitalized form

Interventions

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Digitalized CBT with phone coaching

Digitally delivered CBT intervention with weekly phone coaching

Intervention Type BEHAVIORAL

Psychoeducation about depression

Psychoeducational material about depression in a digitalized form

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Andre Sourander

Professor, Child Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andre Sourander, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Turku, Research Center for Child Psychiatry

Locations

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University of Turku

Turku, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Mari Berglund

Role: CONTACT

+358 504427185

Tiia Ståhlberg

Role: CONTACT

0504381160

Facility Contacts

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Mari Berglund

Role: primary

+358 504427185

Other Identifiers

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DEPMOM-2020

Identifier Type: -

Identifier Source: org_study_id

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