Internet CBT for Antenatal Depression

Karolinska Institute

Status: Enrolling

Conditions: Antenatal Depression

Treatments: Behavioral: Therapist Guided Internet-CBT for antenatal depression; Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice; Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.; Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance

Study type: Interventional

Funder types: Other

Identifiers

NCT05533138

2020-06049

Details and patient eligibility

About

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.

Enrollment: 415 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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415 participants in 4 patient groups

Assessment form allocated by chance & guided ICBT for antenatal depression

Active Comparator group

Description:

Patients are randomized to assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \& and are randomised to treatment with internet-CBT for antenatal depression without extra-support (10 weeks)

Treatment:

Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance

Behavioral: Therapist Guided Internet-CBT for antenatal depression

Assessment form allocated by choice & guided ICBT for antenatal depression

Active Comparator group

Description:

Patients choose assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \& are randomised to treatment with internet-CBT for antenatal depression without extra-support (10 weeks)

Treatment:

Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice

Behavioral: Therapist Guided Internet-CBT for antenatal depression

Assessment form allocated by chance & guided ICBT for antenatal depression with extra support

Experimental group

Description:

Patients are randomized to assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \& and are randomised to treatment with internet-CBT for antenatal depression with extra-support

Treatment:

Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance

Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.

Assessment form allocated by choice & guided ICBT for antenatal depression with extra support

Experimental group

Description:

Patients choose assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \& are randomised to treatment with internet-CBT for antenatal depression with extra-support (10 weeks)

Treatment:

Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.

Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice