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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
415
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.
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.
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.
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.
Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry
Stockholm, Sweden
RECRUITINGChange 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
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
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)
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.
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
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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: Post-assessment and post treatment (after week 10).
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