Antenatal Depression
Conditions
Keywords
Cognitive behavior therapy, Internet treatment, Self-help treatment, Perinatal support
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.
Interventions
BEHAVIORALTherapist Guided Internet-CBT 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.
BEHAVIORALTherapist Guided Internet-CBT for antenatal depression and perinatal extra support.
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.
BEHAVIORALDiagnostic assessment by telephone, video or face-to face - 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 by chance.
BEHAVIORALDiagnostic assessment by telephone, video or face-to face - Allocation by choice
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.
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Multiple Assignment Randomized Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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 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 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 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). |
| Remission of major depression (DSM-5) | 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). |
| 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 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Adverse events | Treatment week 2,4,6,8 | Patient rated adverse events. |
| Assessment of treatment satisfaction - Client Satisfaction Questionnaire-8 (CSQ-8) | 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) |
| Assessment of treatment credibility - Treatment Credibility Scale (TCS) | 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. |
| Assessment of treatment fidelity | Post-treatment (10 weeks) | Clinician rated structured assessment with instrument developed at the clinic for internet psychiatry. |
| Assessment of maternity health care, birth- and child related health and care outcomes - Swedish pregnancy and medical birth registers. | 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. |
| Assessment of empowerment | 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). |
| Assessment of maternal bonding - Mother-to Infant-Bonding-Scale (S-MIBS) | 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). |
| Assessment of childbirth experience - The Childbirth experience scale (CEQ) | 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). |
Countries
Sweden
Contacts
Primary ContactMarie Bendix, PhD
Outcome results
None listed