Internet CBT for Antenatal Depression

Official title

Guided-internet Cognitive Behavioral Therapy for Antenatal Depression - Treatment Effects, Assessment Modalities and Extra Support.

Overview

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

• Behavioral Therapist 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.
• Behavioral Therapist 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.
• Behavioral Diagnostic 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.
• Behavioral Diagnostic 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.

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Change in Edinburgh Postnatal Depression Scale (EPDS) [Time frame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum]
• Remission of major depression (DSM-5) [Time frame: Post-treatment (10 weeks)]
• Remission of major depression (DSM-5) [Time frame: 8-10 weeks postpartum.]
• Change in Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum]
• Change in self-rated Insomnia Severity Index (ISI) [Time frame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum]
• Change in Work and Social Adjustment Scale (WSAS) [Time frame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum]
• Change in Euroqol (EQ-5D-5L) [Time frame: Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum]
• Change in Prenatal Attachment Inventory (PAI) [Time frame: Screening to post-treatment (10 weeks)]
• Change in Experience of close relationships (ENR) [Time frame: Screening to 8-10 weeks post-partum]
• Change in Valentine Scale [Time frame: Screening to 8-10 weeks post-partum]
• Change in Fear of birth scale (FOBS) [Time frame: Screening to post-treatment (after 10 weeks) and to 8-10 weeks post-partum]
• Change in Multidimensional Scale of Perceived Social Support (MSPSS) [Time frame: Screening to 8-10 weeks post-partum]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Double blind

Primary purpose

Treatment

Study locations

Sweden · 1 center

• Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry — Stockholm

Publications

• 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. PMID 28628768

Identifiers

NCT: NCT05533138 · 2020-06049

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗