Internet CBT for Antenatal Depression

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

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 Overview

• Status: Recruiting
• Conditions: Antenatal Depression
• Intervention / Treatment: Behavioral: Therapist Guided Internet-CBT for antenatal depression; Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance; Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice; Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.

• Study Type: Interventional
• Enrollment (Estimated): 415
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Bendix, PhD; Phone Number: +46 73 6370 864; Email: marie.bendix@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 141 86
    • Recruiting
    • Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry
    • Contact: Marie Bendix, PhD; Phone Number: +46 73 637 0864; Email: marie.bendix@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	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: 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.
Active Comparator: 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)	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: 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.
Experimental: 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	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: 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.
Experimental: 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)	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Edinburgh Postnatal Depression Scale (EPDS)	Self-rated measure of antenatal depression (Cox, Holden & Sagovsky, 1987) used for screening of perinatal depression and also as a severity measure. Scores range from 0 to 30 with 13 or more points being the cut off for depression during pregnancy. This scale is validated for Swedish pregnant women (Rubertsson et al., 2011).	Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Remission of major depression (DSM-5)	Diagnostic assessment of major depression assessed by clinician in the same way as before treatment with the depression module of the SCID-I diagnostic interview based on DSM-5 (Spitzer et al., 1992).	Post-treatment (10 weeks)
Remission of major depression (DSM-5)	Diagnostic assessment of major depression assessed by clinician in the same way as before treatment with the depression module of the SCID-I diagnostic interview based on DSM-5 (Spitzer et al., 1992).	8-10 weeks postpartum.
Change in Generalized Anxiety Disorder-7 (GAD-7)	7-item self-assessment measure of symptoms of anxiety and worry (Spitzer et al., 2006). Scores range from 0 to 21 points with 10 points and above indicating clinical levels.	Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in self-rated Insomnia Severity Index (ISI)	7-item, self-rated questionnaire measuring perceived severity of insomnia symptoms (Bastien, Vallières & Morin, 2001). Validated as an outcome measure for insomnia research. The scale includes seven items, scored on a 0-4 scale, that are summed to a range of 0-28. The score can be divided into four categories: no clinical insomnia (0-7), subthreshold insomnia (8-14), clinical insomnia of moderate severity (15-21) and severe clinical insomnia (22-28) (Sarsour et al., 2010).	Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in Work and Social Adjustment Scale (WSAS)	Self-rated measure of level of impairment caused by a condition (Mundt et al. 2002). In this study two versions are used asking about impairment due to depression and due to pregnancy. Scores range from 0 to 40 with scores below 10 points indicating sub clinical impairment and scores above 20 indicating moderately severe impairment or worse.	Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in Euroqol (EQ-5D-5L)	Self-assessed, health related, quality of life questionnaire. 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (Hinz et al., 2014).	Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in Prenatal Attachment Inventory (PAI)	Self-rated measurement of attachment and mentalisation from the mother to the unborn child (Muller 1993; Pallant et al., 2014). 21-items scored on a 1-4 scale.	Screening to post-treatment (10 weeks)
Change in Experience of close relationships (ENR)	Self-reported measurement of adult attachment style (Brennon et al., 1998; Fraley et al., 2000; Strand & Ståhl, 2008). 36 items scored on a 1-7 scale.	Screening to 8-10 weeks post-partum
Change in Valentine Scale	7 item self-rated scale for measurement of satisfaction with the partner relationship (Burman et al., 2018). Range 0-21 with higher values indicating higher partner relationship satisfaction.	Screening to 8-10 weeks post-partum
Change in Fear of birth scale (FOBS)	Self-assessment of fear and worry in relation to the approaching birth using two visual analogue scales (VAS)(Haines et al., 2015) with higher levels indicating increased fear and worry. Also used to assess fear and worry in relation to completed birth after delivery.	Screening to post-treatment (after 10 weeks) and to 8-10 weeks post-partum
Change in Multidimensional Scale of Perceived Social Support (MSPSS)	Measures self-rated perceived social support (Zimet et al., 1988; Ekbäck et al., 2013). 12 items rated on a seven-point Likert-type response format (1 = very strongly disagree; 7 = very strongly agree). Range 12 to 84, with higher scores indicating higher perceived social support.	Screening to 8-10 weeks post-partum
Change in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)	Measures healthcare consumption and productivity loss in patients with a psychiatric disorder (Bouwmans et al., 2013).	Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in Clinical Global Impression Severity Scale (CGI-S)	7-item observer-rated scale that measures illness severity (CGI-S) (Guy 1976)	Post-assessment and post treatment (after week 10).
Change in Clinical Global clinical global improvement (CGI-I)	7-item observer-rated scale that measures global improvement (CGI-I) (Guy 1976).	Post-assessment and post treatment (after week 10).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of childbirth experience - The Childbirth experience scale (CEQ)	Measures the childbirth experience (Dencker et al., 2010) on a 22-item 4-point Likert scale assessing agreement with positive and negative statements ranging from 1 (Totally agree), 2 (Mostly agree), 3 (Mostly disagree) to 4 (Totally disagree).	8-10 weeks post-partum
Assessment of maternal bonding - Mother-to Infant-Bonding-Scale (S-MIBS)	Assesses maternal bonding with the infant during the postpartum period. Eight items ranging 0- 3 with higher values indicating more bonding challenges (Taylor et al. 2005, Morelius et al., 2020).	8-10 weeks post-partum
Assessment of Adverse events	Patient rated adverse events.	Treatment week 2,4,6,8
Assessment of Adverse events	Patient rated adverse events.	Post-treatment (10 weeks)
Assessment of Adverse events	Patient rated adverse events.	8-10 weeks post-partum
Assessment of Adverse events	Clinician rated adverse events.	Post-treatment (10 weeks).
Assessment of treatment satisfaction - Client Satisfaction Questionnaire-8 (CSQ-8)	Measures self-rated satisfaction with treatment with scores from 8 to 32 where 8-13 indicates poor, 14-19 fair, 20-25 good and 26-32 excellent satisfaction (Attkisson and Zwick, 1982; Smith et al. 2014)	Post-treatment (10 weeks)
Assessment of treatment satisfaction - Client Satisfaction Questionnaire-8 (CSQ-8)	Measures self-rated satisfaction with treatment with scores from 8 to 32 where 8-13 indicates poor, 14-19 fair, 20-25 good and 26-32 excellent satisfaction (Attkisson and Zwick, 1982; Smith et al. 2014)	8-10 weeks postpartum
Assessment of treatment credibility - Treatment Credibility Scale (TCS)	The Treatment Credibility Scale is a version of the credibility/expectancy questionnaire (Devilly and Borkovec, 2000) assessing how well the respondent thinks the treatment would work for similar problems. Scores range from 5 to 50.	Treatment week 2
Assessment of treatment credibility - Treatment Credibility Scale (TCS)	The Treatment Credibility Scale is a version of the credibility/expectancy questionnaire (Devilly and Borkovec, 2000) assessing how well the respondent thinks the treatment would work for similar problems. Scores range from 5 to 50.	Treatment week 4
Assessment of treatment fidelity	Clinician rated structured assessment with instrument developed at the clinic for internet psychiatry.	Post-treatment (10 weeks)
Assessment of maternity health care, birth- and child related health and care outcomes - Swedish pregnancy and medical birth registers.	Register data from the Swedish pregnancy and Medical Birth registers regering data on demographic, material health care, delivery care and child related outcomes will be linked by means of the unique personal identification number.	Pregnancy to 8-10 weeks postpartum
Assessment of empowerment	Patient rated empowerment rated with the 28-item "Empowerment Scale" (Rogers et al. 1997).	Post-assessment, post treatment (after week 10) and 8-10 weeks postpartum

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Marie Bendix, PhD, Karolinska Institutet

Publications and helpful links

General 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.

Helpful Links

• The homepage for the study where patients can register

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive behavior therapy; Internet treatment; Self-help treatment; Perinatal support
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2020-06049

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No