|

Internet CBT for Antenatal Depression

RECRUITINGN/ASponsored by Karolinska Institutet
Actively Recruiting
PhaseN/A
SponsorKarolinska Institutet
Started2021-02-25
Est. completion2025-12-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions2

Antenatal DepressionDepression

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.