A Randomized Controlled Study of Digitalized Cognitive Behavioral Intervention for Antenatal Depression
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Digitalized CBT intervention with phone coaching Participants receive weekly sessions of internet-based CBT, including telephone coaching |
Behavioral: Digitalized CBT with phone coaching
Digitally delivered CBT intervention with weekly phone coaching
|
Active Comparator: Psychoeducation about depression Participants receive psychoeducative material about depression in digitalized form. |
Other: Psychoeducation about depression
Psychoeducational material about depression in a digitalized form
|
Outcome Measures
Primary Outcome Measures
- Change in the Edinburgh Postnatal Depression Scale (EPDS) [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 Outcome Measures
- Change in the General Anxiety Disorder 7-item scale (GAD-7) [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.
- Change in the Beck Depression Inventory II (BDI-II) [Baseline and 11 weeks after randomization]
To assess the change in depressive symptoms BDI-II will be used.
- Social Phobia Inventory (SPIN) [Baseline and 11 weeks after randomization]
To assess the change in Social Phobia SPIN will be used
- Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ) [Baseline and 11 weeks after randomization]
To assess the change in pregnancy related anxiety PRAQ will be used
- Perceived Stress Scale (PSS) [Baseline and 11 weeks after randomization]
To assess the change in perceived stress PSS will be used
Eligibility Criteria
Criteria
Inclusion Criteria:
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fluent in written and spoken Finnish or Swedish
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access to computer or mobile phone with internet
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between 12 and 22 weeks pregnant
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screening and baseline score on the EPDS ≥10 points
Exclusion Criteria:
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lifetime history of psychotic disorder (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, psychotic depression)
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active suicidal ideation
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severe substance abuse or dependence
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actively ongoing psychotherapy
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participates in another intervention study aiming at treating the symptoms of antenatal depression
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multiple pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Turku | Turku | Finland |
Sponsors and Collaborators
- University of Turku
Investigators
- Principal Investigator: Andre Sourander, Professor, University of Turku, Research Center for Child Psychiatry
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DEPMOM-2020