Internet CBT for Antenatal Depression

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Karolinska Institute

Status

Enrolling

Conditions

Antenatal Depression

Treatments

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
Behavioral: Therapist Guided Internet-CBT for antenatal depression

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

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: Therapist Guided Internet-CBT for antenatal depression
Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance
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: Therapist Guided Internet-CBT for antenatal depression
Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice
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

Trial contacts and locations

0

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Central trial contact

Marie Bendix, PhD

Data sourced from clinicaltrials.gov

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