Internet CBT for Antenatal Depression
ConditionAntenatal Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKarolinska Institutet
About this trial
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
Qualifiers
Mild to moderate major depression
Pregnant at treatment start
Regular contact with maternity mental health clinic
> 18 years old
Disqualifiers
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
Trial design
Treatments tested in this trial
- Therapist Guided Internet-CBT for antenatal depression
- Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.
- Diagnostic assessment by telephone, video or face-to face - Allocation by chance
- Diagnostic assessment by telephone, video or face-to face - Allocation by choice
Treatment groups
415 Participants
are divided into 4 treatment groupsSponsors and collaborators
Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
Source ClinicalTrials.gov