Internet-based therapy for pregnant women with depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on pregnant women between 8 to 29 weeks gestation who screen positive for antenatal depression. Participants will be randomly assigned to different diagnostic assessment methods and then to either therapist-guided Internet-delivered Cognitive Behavioral Therapy (ICBT) or ICBT with additional support from a midwife or mental health nurse. The primary goal is to determine if extra support enhances the effectiveness of ICBT in reducing depressive symptoms. Secondary objectives include evaluating treatment satisfaction and the impact of assessment methods on treatment outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry
  Stockholm, Sweden Recruiting

Study contacts

• Principal investigator: Marie Bendix, PhD — Karolinska Institutet
• Study coordinator: Marie Bendix, PhD
• Email: marie.bendix@ki.se
• Phone: +46 73 6370 864

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.