Guided-internet Cognitive Behavioral Therapy for Antenatal Depression - Treatment Effects, Assessment Modalities and Extra Support.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 415
- Locations
- 1
- Primary Endpoint
- Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Assessment form allocated by chance & guided ICBT 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)
Intervention: Therapist Guided Internet-CBT for antenatal depression (Behavioral)
Assessment form allocated by chance & guided ICBT 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)
Intervention: Diagnostic assessment by telephone, video or face-to face - Allocation by chance (Behavioral)
Assessment form allocated by choice & guided ICBT 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)
Intervention: Therapist Guided Internet-CBT for antenatal depression (Behavioral)
Assessment form allocated by choice & guided ICBT 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)
Intervention: Diagnostic assessment by telephone, video or face-to face - Allocation by choice (Behavioral)
Assessment form allocated by chance & guided ICBT for antenatal depression with 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
Intervention: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support. (Behavioral)
Assessment form allocated by chance & guided ICBT for antenatal depression with 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
Intervention: Diagnostic assessment by telephone, video or face-to face - Allocation by chance (Behavioral)
Assessment form allocated by choice & guided ICBT for antenatal depression with 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)
Intervention: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support. (Behavioral)
Assessment form allocated by choice & guided ICBT for antenatal depression with 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)
Intervention: Diagnostic assessment by telephone, video or face-to face - Allocation by choice (Behavioral)
Outcomes
Primary Outcomes
Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S)
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
Secondary Outcomes
- 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)
- Change in Clinical Global clinical global improvement (CGI-I)(Post-assessment and post treatment (after week 10).)
- Remission of major depression (DSM-5)(8-10 weeks postpartum.)
- Change in Work and Social Adjustment Scale (WSAS)(Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum)
- Change in Euroqol (EQ-5D-5L)(Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum)
- Change in Prenatal Attachment Inventory (PAI)(Screening to post-treatment (10 weeks))
- Change in Edinburgh Postnatal Depression Scale (EPDS)(Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum)
- Change in Multidimensional Scale of Perceived Social Support (MSPSS)(Screening to 8-10 weeks post-partum)
- Change in Generalized Anxiety Disorder-7 (GAD-7)(Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum)
- Change in self-rated Insomnia Severity Index (ISI)(Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum)
- Change in Experience of close relationships (ENR)(Screening to 8-10 weeks post-partum)
- Change in Valentine Scale(Screening to 8-10 weeks post-partum)
- Change in Fear of birth scale (FOBS)(Screening to post-treatment (after 10 weeks) and to 8-10 weeks post-partum)
- Change in Clinical Global Impression Severity Scale (CGI-S)(Post-assessment and post treatment (after week 10).)
- Remission of major depression (DSM-5)(Post-treatment (10 weeks))
Investigators
Marie Bendix
Principal investigator
Karolinska Institutet