Internet CBT for Antenatal Depression

Study Overview
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Brief Summary
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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.

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

Conditions
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Antenatal Depression

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Multiple Assignment Randomized Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Assessment form allocated by chance & guided ICBT for antenatal depression<br>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) | Behavioral: Therapist Guided Internet-CBT for antenatal depression<br>* 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.<br>Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance<br>* 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.<br>|
| Active Comparator: Assessment form allocated by choice & guided ICBT for antenatal depression<br>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) | Behavioral: Therapist Guided Internet-CBT for antenatal depression<br>* 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.<br>Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice<br>* 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.<br>|
| Experimental: Assessment form allocated by chance & guided ICBT for antenatal depression with extra support<br>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 | Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.<br>* 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.<br>Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance<br>* 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.<br>|
| Experimental: Assessment form allocated by choice & guided ICBT for antenatal depression with extra support<br>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) | Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.<br>* 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.<br>Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum | 
| 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). | Post-treatment (10 weeks) | 
| 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). | 8-10 weeks postpartum. | 
| 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. | Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum | 
| Change in self-rated Insomnia Severity Index (ISI) | 7-item, self-rated questionnaire measuring perceived severity of insomnia symptoms (Bastien, Vallières & Morin, 2001). Validated as an outcome measure for insomnia research. The scale includes seven items, scored on a 0-4 scale, that are summed to a range of 0-28. The score can be divided into four categories: no clinical insomnia (0-7), subthreshold insomnia (8-14), clinical insomnia of moderate severity (15-21) and severe clinical insomnia (22-28) (Sarsour et al., 2010). | Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum | 
| Change in Work and Social Adjustment Scale (WSAS) | Self-rated measure of level of impairment caused by a condition (Mundt et al. 2002). In this study two versions are used asking about impairment due to depression and due to pregnancy. Scores range from 0 to 40 with scores below 10 points indicating sub clinical impairment and scores above 20 indicating moderately severe impairment or worse. | Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum | 
| Change in Euroqol (EQ-5D-5L) | Self-assessed, health related, quality of life questionnaire. 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (Hinz et al., 2014). | Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum | 
| Change in Prenatal Attachment Inventory (PAI) | Self-rated measurement of attachment and mentalisation from the mother to the unborn child (Muller 1993; Pallant et al., 2014). 21-items scored on a 1-4 scale. | Screening to post-treatment (10 weeks) | 
| Change in Experience of close relationships (ENR) | Self-reported measurement of adult attachment style (Brennon et al., 1998; Fraley et al., 2000; Strand & Ståhl, 2008). 36 items scored on a 1-7 scale. | Screening to 8-10 weeks post-partum | 
| Change in Valentine Scale | 7 item self-rated scale for measurement of satisfaction with the partner relationship (Burman et al., 2018). Range 0-21 with higher values indicating higher partner relationship satisfaction. | Screening to 8-10 weeks post-partum | 
| Change in Fear of birth scale (FOBS) | Self-assessment of fear and worry in relation to the approaching birth using two visual analogue scales (VAS)(Haines et al., 2015) with higher levels indicating increased fear and worry. Also used to assess fear and worry in relation to completed birth after delivery. | Screening to post-treatment (after 10 weeks) and to 8-10 weeks post-partum | 
| Change in Multidimensional Scale of Perceived Social Support (MSPSS) | Measures self-rated perceived social support (Zimet et al., 1988; Ekbäck et al., 2013). 12 items rated on a seven-point Likert-type response format (1 = very strongly disagree; 7 = very strongly agree). Range 12 to 84, with higher scores indicating higher perceived social support. | Screening to 8-10 weeks post-partum | 
| Change in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) | Measures healthcare consumption and productivity loss in patients with a psychiatric disorder (Bouwmans et al., 2013). | Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum | 
| Change in Clinical Global Impression Severity Scale (CGI-S) | 7-item observer-rated scale that measures illness severity (CGI-S) (Guy 1976) | Post-assessment and post treatment (after week 10). | 
| Change in Clinical Global clinical global improvement (CGI-I) | 7-item observer-rated scale that measures global improvement (CGI-I) (Guy 1976). | Post-assessment and post treatment (after week 10). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-help treatment, Perinatal support, Cognitive behavior therapy, Internet treatment