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

Plain Language Summary

Simplified for easier understanding

This study is testing an internet-delivered cognitive behavioral therapy (CBT) program for pregnant women with mild-to-moderate depression, to see if online therapy can safely and effectively reduce symptoms during pregnancy. **You may be eligible if...** - You are pregnant (you must be between gestational weeks 8 and 30 when starting treatment) - You are over 18 years old - You have mild to moderate major depression - You are in regular contact with a maternity mental health clinic - If you are on medication for depression or another psychiatric condition, your dose has been stable for at least 3 weeks - You can use the internet and a mobile phone throughout treatment - You understand written and spoken Swedish **You may NOT be eligible if...** - Your depression is very mild (MADRS-S score below 15) or severe (above 35) - You have a high risk of self-harm or suicide - You have a psychiatric condition, physical complication, or pregnancy problem that would prevent or be worsened by treatment - You are already in a similar psychological treatment program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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