Stronger Together: Antenatal Depressive Symptoms - Prevalence and Digital Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorUniversity of Turku
About this trial
The main objective of the current research project is to evaluate the usability, satisfaction of the antenatal iCBT program including telephone coaching for antenatal and postnatal depressive symptoms and collect nationally representative data on population-based screening of antenatal depressive and anxiety symptoms. The overarching hypothesis is that iCBT, with easy access and affordability, is user friendly and well accepted. In addition to examining the treatment response by questionnaires, we will study the infant development comprehensively as well as potential physiological changes associated with antenatal depression or its treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
lifetime history of psychotic disorder (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, psychotic depression)
active suicidal ideation
severe substance abuse or dependence
participates in another intervention study aiming at treating the symptoms of antenatal depression
Trial design
Design model
Single group
Treatments tested in this trial
Digitalized CBT with phone coaching
BehavioralDigitally delivered CBT intervention with weekly phone coaching
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: CBT InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 11 weeks after baselineSecondary outcomes
1
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.
Time frame
Baseline and 11 weeks after baseline2
Change in the Beck Depression Inventory II (BDI-II)
To assess the change in depressive symptoms BDI-II will be used.
Time frame
Baseline and 11 weeks after baseline3
Social Phobia Inventory (SPIN)
To assess the change in Social Phobia SPIN will be used
Time frame
Baseline and 11 weeks after baseline4
Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)
To assess the change in pregnancy related anxiety PRAQ will be used
Time frame
Baseline and 11 weeks after baselineSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: