Recruiting

Internet CBT for Antenatal Depression

ClinicalTrials.gov IDNCT05533138

PhaseNA

Enrollment415

SponsorKarolinska Institutet

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Antenatal Depression

About this study

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.

Interventions

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.

Primary outcomes

Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S) (Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum)

Eligibility information

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

Study locations

Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry, Stockholm, 141 86 Sweden

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.