Clinical trial NCT05533138: Internet CBT for Antenatal Depression
Official title: Guided-internet Cognitive Behavioral Therapy for Antenatal Depression - Treatment Effects, Assessment Modalities and Extra Support.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Antenatal Depression
Keywords: Cognitive behavior therapy
Internet treatment
Self-help treatment
Perinatal support
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2022-09-08
Enrollment: 415
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multiple Assignment Randomized Trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S)
timeFrame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Secondary outcomes:
measure: Change in Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
measure: Remission of major depression (DSM-5)
timeFrame: Post-treatment (10 weeks)
measure: Remission of major depression (DSM-5)
timeFrame: 8-10 weeks postpartum.
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum
measure: Change in self-rated Insomnia Severity Index (ISI)
timeFrame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
measure: Change in Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
measure: Change in Euroqol (EQ-5D-5L)
timeFrame: Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum
measure: Change in Prenatal Attachment Inventory (PAI)
timeFrame: Screening to post-treatment (10 weeks)
measure: Change in Experience of close relationships (ENR)
timeFrame: Screening to 8-10 weeks post-partum
measure: Change in Valentine Scale
timeFrame: Screening to 8-10 weeks post-partum
measure: Change in Fear of birth scale (FOBS)
timeFrame: Screening to post-treatment (after 10 weeks) and to 8-10 weeks post-partum
measure: Change in Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Screening to 8-10 weeks post-partum
measure: Change in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
timeFrame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
measure: Change in Clinical Global Impression Severity Scale (CGI-S)
timeFrame: Post-assessment and post treatment (after week 10).
measure: Change in Clinical Global clinical global improvement (CGI-I)
timeFrame: Post-assessment and post treatment (after week 10).
Other outcomes:
measure: Assessment of childbirth experience - The Childbirth experience scale (CEQ)
timeFrame: 8-10 weeks post-partum
measure: Assessment of maternal bonding - Mother-to Infant-Bonding-Scale (S-MIBS)
timeFrame: 8-10 weeks post-partum
measure: Assessment of Adverse events
timeFrame: Treatment week 2,4,6,8
measure: Assessment of Adverse events
timeFrame: Post-treatment (10 weeks)
measure: Assessment of Adverse events
timeFrame: 8-10 weeks post-partum
measure: Assessment of Adverse events
timeFrame: Post-treatment (10 weeks).
measure: Assessment of treatment satisfaction - Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Post-treatment (10 weeks)
measure: Assessment of treatment satisfaction - Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: 8-10 weeks postpartum
measure: Assessment of treatment credibility - Treatment Credibility Scale (TCS)
timeFrame: Treatment week 2
measure: Assessment of treatment credibility - Treatment Credibility Scale (TCS)
timeFrame: Treatment week 4
measure: Assessment of treatment fidelity
timeFrame: Post-treatment (10 weeks)
measure: Assessment of maternity health care, birth- and child related health and care outcomes - Swedish pregnancy and medical birth registers.
timeFrame: Pregnancy to 8-10 weeks postpartum
measure: Assessment of empowerment
timeFrame: Post-assessment, post treatment (after week 10) and 8-10 weeks postpartum
Locations:
city: Stockholm
country: Sweden
facility: Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry
Study officials:
affiliation: Karolinska Institutet
name: Marie Bendix, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.