Health TrialsbyHealthPanel

Internet CBT for Antenatal Depression

ConditionAntenatal Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKarolinska Institutet

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Mild to moderate major depression

Pregnant at treatment start

Regular contact with maternity mental health clinic

> 18 years old

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Therapist Guided Internet-CBT for antenatal depression

    Behavioral

    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.

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

    Behavioral

    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.

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

    Behavioral

    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.

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

    Behavioral

    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.

Treatment groups

415 Participants
are divided into 4 treatment groups
Group A: Assessment form allocated by chance & guided ICBT for antenatal depressionActive comparator 2 interventions
Group B: Assessment form allocated by choice & guided ICBT for antenatal depressionActive comparator 2 interventions
Group C: Assessment form allocated by chance & guided ICBT for antenatal depression with extra supportExperimental treatment 2 interventions
Group D: Assessment form allocated by choice & guided ICBT for antenatal depression with extra supportExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S)

A 9-item self-rated measure of depression severity that also screens for suicidality (Montgomery \& Asberg, 1979). Scores range from 0 to 54 points with 13-19 points indicating mild depression, 20-34 points indicating moderate depression and 35-54 points indicating severe depression

Time frame
Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum

Secondary outcomes

1

Change in Edinburgh Postnatal Depression Scale (EPDS)

Self-rated measure of antenatal depression (Cox, Holden \& Sagovsky, 1987) used for screening of perinatal depression and also as a severity measure. Scores range from 0 to 30 with 13 or more points being the cut off for depression during pregnancy. This scale is validated for Swedish pregnant women (Rubertsson et al., 2011).

Time frame
Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
2

Remission of major depression (DSM-5)

Diagnostic assessment of major depression assessed by clinician in the same way as before treatment with the depression module of the SCID-I diagnostic interview based on DSM-5 (Spitzer et al., 1992).

Time frame
Post-treatment (10 weeks)
3

Remission of major depression (DSM-5)

Diagnostic assessment of major depression assessed by clinician in the same way as before treatment with the depression module of the SCID-I diagnostic interview based on DSM-5 (Spitzer et al., 1992).

Time frame
8-10 weeks postpartum.
4

Change in Generalized Anxiety Disorder-7 (GAD-7)

7-item self-assessment measure of symptoms of anxiety and worry (Spitzer et al., 2006). Scores range from 0 to 21 points with 10 points and above indicating clinical levels.

Time frame
Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum

Other outcomes

1

Assessment of childbirth experience - The Childbirth experience scale (CEQ)

Measures the childbirth experience (Dencker et al., 2010) on a 22-item 4-point Likert scale assessing agreement with positive and negative statements ranging from 1 (Totally agree), 2 (Mostly agree), 3 (Mostly disagree) to 4 (Totally disagree).

Time frame
8-10 weeks post-partum
2

Assessment of maternal bonding - Mother-to Infant-Bonding-Scale (S-MIBS)

Assesses maternal bonding with the infant during the postpartum period. Eight items ranging 0- 3 with higher values indicating more bonding challenges (Taylor et al. 2005, Morelius et al., 2020).

Time frame
8-10 weeks post-partum
3

Assessment of Adverse events

Patient rated adverse events.

Time frame
Treatment week 2,4,6,8
4

Assessment of Adverse events

Patient rated adverse events.

Time frame
Post-treatment (10 weeks)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Region Stockholm

Collaborator

Source ClinicalTrials.gov
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