Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry
Stockholm, 141 86, Sweden
Location status: Recruiting
NCT Number: NCT05533138
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.
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Request Info18 year and older
Female
Interventional
Not applicable
Stockholm, 141 86, Sweden
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 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).
Time frame: Post-treatment (10 weeks)
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.
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: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Post-assessment and post treatment (after week 10).
7-item observer-rated scale that measures illness severity (CGI-S) (Guy 1976)
Time frame: Post-assessment and post treatment (after week 10).
7-item observer-rated scale that measures global improvement (CGI-I) (Guy 1976).
Time frame: 8-10 weeks post-partum
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
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: Treatment week 2,4,6,8
Patient rated adverse events.
Time frame: Post-treatment (10 weeks)
Patient rated adverse events.
Time frame: 8-10 weeks post-partum
Patient rated adverse events.
Time frame: Post-treatment (10 weeks).
Clinician rated adverse events.
Time frame: Post-treatment (10 weeks)
Measures self-rated satisfaction with treatment with scores from 8 to 32 where 8-13 indicates poor, 14-19 fair, 20-25 good and 26-32 excellent satisfaction (Attkisson and Zwick, 1982; Smith et al. 2014)
Time frame: 8-10 weeks postpartum
Measures self-rated satisfaction with treatment with scores from 8 to 32 where 8-13 indicates poor, 14-19 fair, 20-25 good and 26-32 excellent satisfaction (Attkisson and Zwick, 1982; Smith et al. 2014)
Time frame: Treatment week 2
The Treatment Credibility Scale is a version of the credibility/expectancy questionnaire (Devilly and Borkovec, 2000) assessing how well the respondent thinks the treatment would work for similar problems. Scores range from 5 to 50.
Time frame: Treatment week 4
The Treatment Credibility Scale is a version of the credibility/expectancy questionnaire (Devilly and Borkovec, 2000) assessing how well the respondent thinks the treatment would work for similar problems. Scores range from 5 to 50.
Time frame: Post-treatment (10 weeks)
Clinician rated structured assessment with instrument developed at the clinic for internet psychiatry.
Time frame: Pregnancy to 8-10 weeks postpartum
Register data from the Swedish pregnancy and Medical Birth registers regering data on demographic, material health care, delivery care and child related outcomes will be linked by means of the unique personal identification number.
Time frame: Post-assessment, post treatment (after week 10) and 8-10 weeks postpartum
Patient rated empowerment rated with the 28-item "Empowerment Scale" (Rogers et al. 1997).
Contact information is provided by the study sponsor or research team.
Karolinska Institutet
Other
Guided-internet Cognitive Behavioral Therapy for Antenatal Depression - Treatment Effects, Assessment Modalities and Extra Support.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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