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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assessment form allocated by chance & guided ICBT for antenatal depression | Active Comparator | 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 choice & guided ICBT for antenatal depression | Active Comparator | 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 with extra support | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 8-10 weeks post-partum |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie Bendix, PhD | Contact | +46 73 6370 864 | marie.bendix@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Marie Bendix, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry | Recruiting | Stockholm | 141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28628768 | Background | Forsell E, Bendix M, Hollandare F, Szymanska von Schultz B, Nasiell J, Blomdahl-Wetterholm M, Eriksson C, Kvarned S, Lindau van der Linden J, Soderberg E, Jokinen J, Wide K, Kaldo V. Internet delivered cognitive behavior therapy for antenatal depression: A randomised controlled trial. J Affect Disord. 2017 Oct 15;221:56-64. doi: 10.1016/j.jad.2017.06.013. Epub 2017 Jun 13. |
| Label | URL |
|---|---|
| The homepage for the study where patients can register | View source |
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Multiple Assignment Randomized Trial
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Participants are blinded for allocation to perinatal extra support in addition to therapist-guided internet CBT treatment.
Outcome is assessed by an independent assessor who is blind for whether patient chose or was allocated to assessment modality and whether patient received extra-support or not.
| Experimental |
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) |
|
| 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. |
|
| 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). |
| 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). |
| 8-10 weeks post-partum |
| Assessment of Adverse events | Patient rated adverse events. | Treatment week 2,4,6,8 |
| Assessment of Adverse events | Patient rated adverse events. | Post-treatment (10 weeks) |
| Assessment of Adverse events | Patient rated adverse events. | 8-10 weeks post-partum |
| Assessment of Adverse events | Clinician rated adverse events. | Post-treatment (10 weeks). |
| Assessment of treatment satisfaction - Client Satisfaction Questionnaire-8 (CSQ-8) | 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) | Post-treatment (10 weeks) |
| Assessment of treatment satisfaction - Client Satisfaction Questionnaire-8 (CSQ-8) | 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) | 8-10 weeks postpartum |
| Assessment of treatment credibility - Treatment Credibility Scale (TCS) | 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. | Treatment week 2 |
| Assessment of treatment credibility - Treatment Credibility Scale (TCS) | 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. | Treatment week 4 |
| Assessment of treatment fidelity | Clinician rated structured assessment with instrument developed at the clinic for internet psychiatry. | Post-treatment (10 weeks) |
| Assessment of maternity health care, birth- and child related health and care outcomes - Swedish pregnancy and medical birth registers. | 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. | Pregnancy to 8-10 weeks postpartum |
| Assessment of empowerment | Patient rated empowerment rated with the 28-item "Empowerment Scale" (Rogers et al. 1997). | Post-assessment, post treatment (after week 10) and 8-10 weeks postpartum |
| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
| D013690 | Television |
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