Randomized Controlled Trial of Digitalized Cognitive Behavioral Therapy With Telephone Coaching for Mothers Suffering From Depression During Pregnancy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- University of Turku
- Enrollment
- 634
- Locations
- 1
- Primary Endpoint
- Change in the Edinburgh Postnatal Depression Scale (EPDS)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Andre Sourander
Professor, Child Psychiatry
University of Turku
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Social Phobia Inventory (SPIN)(Baseline and 11 weeks after randomization)
- Change in the General Anxiety Disorder 7-item scale (GAD-7)(Baseline and 11 weeks after randomization)
- Change in the Beck Depression Inventory II (BDI-II)(Baseline and 11 weeks after randomization)
- Perceived Stress Scale (PSS)(Baseline and 11 weeks after randomization)
- Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)(Baseline and 11 weeks after randomization)