| NCT ID | NCT05533138 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Antenatal Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 415 participants |
| Start Date | 2021-02-25 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 415 participants in total. It began in 2021-02-25 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pregnant women in pregnancy week 8-29 screening positive for antenatal depression will be randomized to either choose or to be allotted by chance to different forms of diagnostic assessment; i.e. telephone, video or face-to-face assessment. Those diagnosed with mild to moderate major depression will then be randomized to treatment with therapist-guided Internet-delivered Cognitive Behavioral Therapy (ICBT) adapted for women suffering from antenatal depression or to the same treatment with addition of up to three contacts with extra support by a midwife or experienced perinatal mental health nurse. The primary aim is to assess whether extrasupport in addition to internet-guided pregnancy adapted ICBT decreases depressive symptoms more than internet-guided pregnancy adapted ICBT only. Secondary aims include effects of extrasupport and assessment mode on treatment satisfaction, fidelity and credibility.
Eligibility 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
Contact & Investigator
Marie Bendix, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT05533138 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Antenatal Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05533138 currently recruiting?
Yes, NCT05533138 is actively recruiting participants. Contact the research team at marie.bendix@ki.se for enrollment information.
Where is the NCT05533138 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05533138 clinical trial?
NCT05533138 is sponsored by Karolinska Institutet. The principal investigator is Marie Bendix, PhD at Karolinska Institutet. The trial plans to enroll 415 participants.
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.