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

Study Overview
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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.

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

Conditions
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Depression, Antenatal Depression

Intervention / Treatment
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* Behavioral: Digitalized CBT with phone coaching
* Other: Psychoeducation about depression


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digitalized CBT intervention with phone coaching<br>Participants receive weekly sessions of internet-based CBT, including telephone coaching | Behavioral: Digitalized CBT with phone coaching<br>* Digitally delivered CBT intervention with weekly phone coaching<br>|
| Active Comparator: Psychoeducation about depression<br>Participants receive psychoeducative material about depression in digitalized form. | Other: Psychoeducation about depression<br>* Psychoeducational material about depression in a digitalized form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Social Phobia Inventory (SPIN) | To assess the change in Social Phobia SPIN will be used | Baseline and 11 weeks after randomization | 
| Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ) | To assess the change in pregnancy related anxiety PRAQ will be used | Baseline and 11 weeks after randomization | 
| Perceived Stress Scale (PSS) | To assess the change in perceived stress PSS will be used | Baseline and 11 weeks after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital intervention, cognitive behavioral therapy, antenatal depression