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Internet CBT for Antenatal Depression

RecruitingNAAges 18 Years - anyFemaleKarolinska Institutet
NCT05533138 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
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
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What it tests

  • 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
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Where

1 site
Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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