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

University of Turku

Status: Enrolling

Conditions: Antenatal Depression; Depression

Treatments: Behavioral: Digitalized CBT with phone coaching; Other: Psychoeducation about depression

Study type: Interventional

Funder types: Other

Identifiers

NCT04223115

DEPMOM-2020

Details and patient eligibility

About

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.

Enrollment: 634 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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634 participants in 2 patient groups

Digitalized CBT intervention with phone coaching

Experimental group

Description:

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

Treatment:

Behavioral: Digitalized CBT with phone coaching

Psychoeducation about depression

Active Comparator group

Description:

Participants receive psychoeducative material about depression in digitalized form.

Treatment:

Other: Psychoeducation about depression