NCT05533138

Internet CBT for Antenatal Depression

Guided-internet Cognitive Behavioral Therapy for Antenatal Depression - Treatment Effects, Assessment Modalities and Extra Support.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 415 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Antenatal Depression

Interventions

Type	Name	Description
BEHAVIORAL	Therapist Guided Internet-CBT for antenatal depression	A 10 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression adapted for antenatal depression.
BEHAVIORAL	Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.	A 10 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression adapted for antenatal depression. Additionally, up to three supportive contacts with a midwife or perinatal mental health nurse to support ICBT treatment and adress general pregnancy related health problems.
BEHAVIORAL	Diagnostic assessment by telephone, video or face-to face - Allocation by chance	Structured diagnostic perinatal psychiatric assessment of women screening positive for antenatal depression (pregnancy week 8-29) by telephone, video or in a face-to-face meeting. Assessment form allocation by chance.
BEHAVIORAL	Diagnostic assessment by telephone, video or face-to face - Allocation by choice	Structured diagnostic perinatal psychiatric assessment of women screening positive for antenatal depression (pregnancy week 8-29) by telephone, video or in a face-to-face meeting. Assessment form allocation based on patient preference.

Timeline

• Start date: 2021-02-25
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2022-09-08
• Last updated: 2024-06-25

Locations

1 site across 1 country: Sweden