Internet CBT for Antenatal Depression

NCT05533138 | Recruiting

• 1 other identifier: 2020-06049
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 1

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.

Conditions

Antenatal Depression

Keywords

Cognitive behavior therapy; Internet treatment; Self-help treatment; Perinatal support

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S)

  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

  Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum

Secondary Outcomes (15)

• Change in Edinburgh Postnatal Depression Scale (EPDS)

  Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum

• Remission of major depression (DSM-5)

  Post-treatment (10 weeks)

• Remission of major depression (DSM-5)

  8-10 weeks postpartum.

• 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

Other Outcomes (13)

• Assessment of childbirth experience - The Childbirth experience scale (CEQ)

  8-10 weeks post-partum

• Assessment of maternal bonding - Mother-to Infant-Bonding-Scale (S-MIBS)

  8-10 weeks post-partum

• Assessment of Adverse events

  Treatment week 2,4,6,8

Study Arms (4)

Assessment form allocated by chance & guided ICBT for antenatal depression

ACTIVE COMPARATOR

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)

Behavioral: Therapist Guided Internet-CBT for antenatal depression; Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance

Assessment form allocated by choice & guided ICBT for antenatal depression

ACTIVE COMPARATOR

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)

Behavioral: Therapist Guided Internet-CBT for antenatal depression; Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice

Assessment form allocated by chance & guided ICBT for antenatal depression with extra support

EXPERIMENTAL

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

Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.; Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance

Assessment form allocated by choice & guided ICBT for antenatal depression with extra support

EXPERIMENTAL

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)

Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.; Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice

Interventions

Therapist Guided Internet-CBT for antenatal depression BEHAVIORAL

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.

Assessment form allocated by chance & guided ICBT for antenatal depression; Assessment form allocated by choice & guided ICBT for antenatal depression

Therapist Guided Internet-CBT for antenatal depression and perinatal extra support. BEHAVIORAL

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.

Assessment form allocated by chance & guided ICBT for antenatal depression with extra support; Assessment form allocated by choice & guided ICBT for antenatal depression with extra support

Diagnostic assessment by telephone, video or face-to face - Allocation by chance BEHAVIORAL

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.

Assessment form allocated by chance & guided ICBT for antenatal depression; Assessment form allocated by chance & guided ICBT for antenatal depression with extra support

Diagnostic assessment by telephone, video or face-to face - Allocation by choice BEHAVIORAL

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.

Assessment form allocated by choice & guided ICBT for antenatal depression; Assessment form allocated by choice & guided ICBT for antenatal depression with extra support

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry

Stockholm, 141 86, Sweden

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Related Links

• The homepage for the study where patients can register

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Marie Bendix, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Bendix, PhD

CONTACT

+46 73 6370 864; marie.bendix@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Multiple Assignment Randomized Trial

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: September 8, 2022
• Study Start: February 25, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

SE (1)