Guided-internet Cognitive Behavioral Therapy for Antenatal Depression - Treatment Effects, Assessment Modalities and Extra Support.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Antenatal Depression
- Sponsor
- Karolinska Institutet
- Enrollment
- 415
- Locations
- 1
- Primary Endpoint
- Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S)
- Status
- Recruiting
- Last Updated
- last year
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.
Investigators
Marie Bendix
Principal investigator
Karolinska Institutet
Eligibility Criteria
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
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
- 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 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).)
- 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).)