Internet-based therapy for pregnant women with depression
Guided-internet Cognitive Behavioral Therapy for Antenatal Depression - Treatment Effects, Assessment Modalities and Extra Support.
This study tests if adding extra support from a midwife or mental health nurse makes internet-based therapy more effective for pregnant women dealing with depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 415 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05533138 on ClinicalTrials.gov |
What this trial studies
This study focuses on pregnant women between 8 to 29 weeks gestation who screen positive for antenatal depression. Participants will be randomly assigned to different diagnostic assessment methods and then to either therapist-guided Internet-delivered Cognitive Behavioral Therapy (ICBT) or ICBT with additional support from a midwife or mental health nurse. The primary goal is to determine if extra support enhances the effectiveness of ICBT in reducing depressive symptoms. Secondary objectives include evaluating treatment satisfaction and the impact of assessment methods on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged over 18 with mild to moderate major depression who can access the internet and understand Swedish.
Not a fit: Patients with severe depression, high risk of self-harm, or significant psychiatric comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce depressive symptoms in pregnant women, improving maternal and fetal health outcomes.
How similar studies have performed: Previous studies have shown promising results for internet-based cognitive behavioral therapy in treating depression, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mild to moderate major depression * Pregnant at treatment start * Regular contact with maternity mental health clinic * \> 18 years old * Being able to start the treatment earliest in gestational week 8 and latest in gestational week 30 * Stable medication for depression and/or other psychiatric conditions for at least 3 weeks. * Being able to participate in the treatment during the treatment time and having access to and being able to use the internet and mobile phone during the treatment time * Being able to understand the Swedish language orally and in writing Exclusion Criteria: * Montgomery-Åsberg Depression Rating Scale-Self report version (MADRS-S) score below 15 (symptoms of depression to low) or above 35 (severe depression) * High risk of self harm or suicide (based on semi-structured clinical suicide risk assessment) * Psychiatric comorbidity, disability, somatic disorder, or pregnancy complications that prevent treatment participation or that can be negatively affected or compose a risk for the fetus by treatment participation * Ongoing psychological treatment with similar content
Where this trial is running
Stockholm
- Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Marie Bendix, PhD — Karolinska Institutet
- Study coordinator: Marie Bendix, PhD
- Email: marie.bendix@ki.se
- Phone: +46 73 6370 864
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.