Digital cognitive behavioral therapy for pregnant women with depression
Randomized Controlled Trial of Digitalized Cognitive Behavioral Therapy With Telephone Coaching for Mothers Suffering From Depression During Pregnancy
NA · University of Turku · NCT04223115
This study tests if a digital therapy program with phone support can help pregnant women with depression feel better compared to just getting information about depression.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 634 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | University of Turku (other) |
| Locations | 1 site (Turku) |
| Trial ID | NCT04223115 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a digitalized cognitive behavioral therapy (CBT) program, which includes telephone coaching, for pregnant women experiencing depressive symptoms. Participants are screened from the general population during routine maternity health care check-ups and are randomized into either an intervention group receiving the digital treatment or a control group receiving educational materials about depression. The aim is to determine if this digital approach can effectively alleviate antenatal depressive symptoms.
Who should consider this trial
Good fit: Ideal candidates are pregnant women between 12 and 22 weeks gestation who are fluent in Finnish or Swedish and have depressive symptoms.
Not a fit: Patients with a history of psychotic disorders, active suicidal ideation, or those currently undergoing psychotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide an accessible and effective treatment option for pregnant women suffering from depression.
How similar studies have performed: Other studies have shown promise in using digital interventions for mental health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Turku
- University of Turku — Turku, Finland (RECRUITING)
Study contacts
- Principal investigator: Andre Sourander, Professor — University of Turku, Research Center for Child Psychiatry
- Study coordinator: Mari Berglund
- Email: mari.berglund@utu.fi
- Phone: +358 504427185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression, Antenatal Depression, digital intervention, cognitive behavioral therapy, antenatal depression