Internet CBT for Antenatal Depression
- Conditions
- Antenatal Depression
- Interventions
- Behavioral: Therapist Guided Internet-CBT for antenatal depressionBehavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choiceBehavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance
- Registration Number
- NCT05533138
- Lead Sponsor
- Karolinska Institutet
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 415
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Assessment form allocated by choice & guided ICBT for antenatal depression Diagnostic assessment by telephone, video or face-to face - Allocation by choice 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) Assessment form allocated by chance & guided ICBT for antenatal depression Diagnostic assessment by telephone, video or face-to face - Allocation by chance 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) Assessment form allocated by chance & guided ICBT for antenatal depression Therapist Guided Internet-CBT for antenatal depression 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) Assessment form allocated by chance & guided ICBT for antenatal depression with extra support Diagnostic assessment by telephone, video or face-to face - Allocation by chance 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 Assessment form allocated by chance & guided ICBT for antenatal depression with extra support Therapist Guided Internet-CBT for antenatal depression and perinatal extra support. 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 Assessment form allocated by choice & guided ICBT for antenatal depression with extra support Therapist Guided Internet-CBT for antenatal depression and perinatal extra support. 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) Assessment form allocated by choice & guided ICBT for antenatal depression Therapist Guided Internet-CBT for antenatal depression 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) Assessment form allocated by choice & guided ICBT for antenatal depression with extra support Diagnostic assessment by telephone, video or face-to face - Allocation by choice 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)
- Primary Outcome Measures
Name Time Method Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S) Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum 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
- Secondary Outcome Measures
Name Time Method Remission of major depression (DSM-5) 8-10 weeks postpartum. 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).
Change in Work and Social Adjustment Scale (WSAS) Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum 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.
Change in Euroqol (EQ-5D-5L) Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum 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).
Change in Prenatal Attachment Inventory (PAI) Screening to post-treatment (10 weeks) 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.
Change in Edinburgh Postnatal Depression Scale (EPDS) Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum 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).
Change in Multidimensional Scale of Perceived Social Support (MSPSS) Screening to 8-10 weeks post-partum 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.
Change in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum Measures healthcare consumption and productivity loss in patients with a psychiatric disorder (Bouwmans et al., 2013).
Change in Clinical Global clinical global improvement (CGI-I) Post-assessment and post treatment (after week 10). 7-item observer-rated scale that measures global improvement (CGI-I) (Guy 1976).
Change in Generalized Anxiety Disorder-7 (GAD-7) Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum 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.
Change in self-rated Insomnia Severity Index (ISI) Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum 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).
Change in Experience of close relationships (ENR) Screening to 8-10 weeks post-partum 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.
Change in Clinical Global Impression Severity Scale (CGI-S) Post-assessment and post treatment (after week 10). 7-item observer-rated scale that measures illness severity (CGI-S) (Guy 1976)
Change in Valentine Scale Screening to 8-10 weeks post-partum 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.
Change in Fear of birth scale (FOBS) Screening to post-treatment (after 10 weeks) and to 8-10 weeks post-partum 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.
Trial Locations
- Locations (1)
Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry
🇸🇪Stockholm, Sweden