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NCT Number: NCT04223115

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Depression Antenatal Depression Behavior Behavioral Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Turku

Turku, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digitalized CBT with phone coaching

Behavioral

Digitally delivered CBT intervention with weekly phone coaching

Psychoeducation about depression

Other

Psychoeducational material about depression in a digitalized form

Primary outcomes

  1. Change in the Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: Baseline and 11 weeks after randomization

    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.

Secondary outcomes

  1. Change in the General Anxiety Disorder 7-item scale (GAD-7)

    Time frame: Baseline and 11 weeks after randomization

    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.

  2. Change in the Beck Depression Inventory II (BDI-II)

    Time frame: Baseline and 11 weeks after randomization

    To assess the change in depressive symptoms BDI-II will be used.

  3. Social Phobia Inventory (SPIN)

    Time frame: Baseline and 11 weeks after randomization

    To assess the change in Social Phobia SPIN will be used

  4. Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)

    Time frame: Baseline and 11 weeks after randomization

    To assess the change in pregnancy related anxiety PRAQ will be used

  5. Perceived Stress Scale (PSS)

    Time frame: Baseline and 11 weeks after randomization

    To assess the change in perceived stress PSS will be used

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2020
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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