RecruitingNot ApplicableNCT05533138

Internet CBT for Antenatal Depression

Guided-internet Cognitive Behavioral Therapy for Antenatal Depression - Treatment Effects, Assessment Modalities and Extra Support.


Sponsor

Karolinska Institutet

Enrollment

415 participants

Start Date

Feb 25, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

  • 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 Criteria4

  • 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

Interventions

BEHAVIORALTherapist 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.

BEHAVIORALTherapist 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.

BEHAVIORALDiagnostic 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.

BEHAVIORALDiagnostic 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.


Locations(1)

Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry

Stockholm, Sweden

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NCT05533138


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