Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
FEMALE
ID04223115

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

Led by University of Turku · Updated on 2024-11-26

634

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a digital cognitive behavioral therapy (CBT) program combined with telephone coaching to address depressive symptoms during pregnancy. This randomized controlled trial compares the guided digitalized treatment program to a control group receiving digital education material about depression. The study focuses on pregnant women experiencing antenatal depression, aiming to assess the effectiveness of these digital interventions in improving mental health. Participants are randomly assigned to one of two groups. One group receives weekly internet-based CBT sessions with telephone coaching, while the other group is provided with psychoeducational digital materials about depression. The treatment period lasts 11 weeks after randomization, during which participants engage with their assigned interventions remotely. Throughout the study, participants will be assessed using several mental health questionnaires including the Edinburgh Postnatal Depression Scale (EPDS), General Anxiety Disorder 7-item scale (GAD-7), Beck Depression Inventory II (BDI-II), Social Phobia Inventory (SPIN), Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ), and Perceived Stress Scale (PSS). These assessments occur at the start of the study and 11 weeks later to measure changes in symptoms. The research team monitors participant progress and collects data to evaluate the interventions' impact on antenatal depression and related anxiety and stress symptoms.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 Edinburgh Postnatal Depression Scale (EPDS) 10 points
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 11 weeks

Participants undergo weekly sessions of internet-based cognitive behavioral therapy with telephone coaching or receive digital psychoeducational material about depression.

Weekly visits for up to 11 weeks

Trial Site Locations

Total: 1 location

1

University of Turku

Turku, Finland

Actively Recruiting

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Research Team

M

Mari Berglund

T

Tiia Ståhlberg

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Internet-assisted cognitive behavioral therapy with telephone coaching versus an educational control for antenatal depression: protocol for a randomized controlled trial with population-based screening.

Andre Sourander, Tarja Korpilahti-Leino, Terja Ristkari...

https://pubmed.ncbi.nlm.nih.gov/41256941