Back to resultsInternet CBT for Antenatal Depression
Primary Purpose
Antenatal Depression
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Therapist Guided Internet-CBT for antenatal depression
Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.
Diagnostic assessment by telephone, video or face-to face - Allocation by chance
Diagnostic assessment by telephone, video or face-to face - Allocation by choice
Sponsored by
About this trial
This is an interventional treatment trial for Antenatal Depression focused on measuring Cognitive behavior therapy, Internet treatment, Self-help treatment, Perinatal support
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
Sites / Locations
- Psychiatry Southwest, Department of CL Psychiatry & InternetpsychiatryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
Assessment form allocated by chance & guided ICBT for antenatal depression
Assessment form allocated by choice & guided ICBT for antenatal depression
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
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
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).
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).
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.
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).
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.
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).
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.
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.
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.
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.
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.
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).
Change in Clinical Global Impression Severity Scale (CGI-S)
7-item observer-rated scale that measures illness severity (CGI-S) (Guy 1976)
Change in Clinical Global clinical global improvement (CGI-I)
7-item observer-rated scale that measures global improvement (CGI-I) (Guy 1976).
Full Information
NCT ID
NCT05533138
First Posted
June 27, 2022
Last Updated
September 5, 2022
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT05533138
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antenatal Depression
Keywords
Cognitive behavior therapy, Internet treatment, Self-help treatment, Perinatal support
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Multiple Assignment Randomized Trial
Masking
ParticipantOutcomes Assessor
Masking Description
Participants are blinded for allocation to diagnostic assessment form and randomisation to receive perinatal extra support in addition to therapist-guided internet CBT treatment.
Outcome is assessed by an independent assessor.
Allocation
Randomized
Enrollment
415 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Assessment form allocated by chance & guided ICBT for antenatal depression
Arm Type
Active Comparator
Arm Title
Assessment form allocated by choice & guided ICBT for antenatal depression
Arm Type
Active Comparator
Arm Title
Assessment form allocated by chance & guided ICBT for antenatal depression with extra support
Arm Type
Experimental
Arm Title
Assessment form allocated by choice & guided ICBT for antenatal depression with extra support
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Therapist Guided Internet-CBT for antenatal depression
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diagnostic assessment by telephone, video or face-to face - Allocation by chance
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diagnostic assessment by telephone, video or face-to face - Allocation by choice
Intervention Description
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 Measure Information:
Title
Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S)
Description
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
Time Frame
Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Secondary Outcome Measure Information:
Title
Change in Edinburgh Postnatal Depression Scale (EPDS)
Description
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).
Time Frame
Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Title
Remission of major depression (DSM-5)
Description
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).
Time Frame
Post-treatment (10 weeks)
Title
Remission of major depression (DSM-5)
Description
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).
Time Frame
8-10 weeks postpartum.
Title
Change in Generalized Anxiety Disorder-7 (GAD-7)
Description
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.
Time Frame
Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum
Title
Change in self-rated Insomnia Severity Index (ISI)
Description
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).
Time Frame
Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Title
Change in Work and Social Adjustment Scale (WSAS)
Description
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.
Time Frame
Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Title
Change in Euroqol (EQ-5D-5L)
Description
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).
Time Frame
Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum
Title
Change in Prenatal Attachment Inventory (PAI)
Description
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.
Time Frame
Screening to post-treatment (10 weeks)
Title
Change in Experience of close relationships (ENR)
Description
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.
Time Frame
Screening to 8-10 weeks post-partum
Title
Change in Valentine Scale
Description
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.
Time Frame
Screening to 8-10 weeks post-partum
Title
Change in Fear of birth scale (FOBS)
Description
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.
Time Frame
Screening to post-treatment (after 10 weeks) and to 8-10 weeks post-partum
Title
Change in Multidimensional Scale of Perceived Social Support (MSPSS)
Description
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.
Time Frame
Screening to 8-10 weeks post-partum
Title
Change in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Description
Measures healthcare consumption and productivity loss in patients with a psychiatric disorder (Bouwmans et al., 2013).
Time Frame
Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Title
Change in Clinical Global Impression Severity Scale (CGI-S)
Description
7-item observer-rated scale that measures illness severity (CGI-S) (Guy 1976)
Time Frame
Post-assessment and post treatment (after week 10).
Title
Change in Clinical Global clinical global improvement (CGI-I)
Description
7-item observer-rated scale that measures global improvement (CGI-I) (Guy 1976).
Time Frame
Post-assessment and post treatment (after week 10).
Other Pre-specified Outcome Measures:
Title
Assessment of childbirth experience - The Childbirth experience scale (CEQ)
Description
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).
Time Frame
8-10 weeks post-partum
Title
Assessment of maternal bonding - Mother-to Infant-Bonding-Scale (S-MIBS)
Description
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).
Time Frame
8-10 weeks post-partum
Title
Assessment of Adverse events
Description
Patient rated adverse events.
Time Frame
Treatment week 2,4,6,8
Title
Assessment of Adverse events
Description
Patient rated adverse events.
Time Frame
Post-treatment (10 weeks)
Title
Assessment of Adverse events
Description
Patient rated adverse events.
Time Frame
8-10 weeks post-partum
Title
Assessment of Adverse events
Description
Clinician rated adverse events.
Time Frame
Post-treatment (10 weeks).
Title
Assessment of treatment satisfaction - Client Satisfaction Questionnaire-8 (CSQ-8)
Description
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)
Time Frame
Post-treatment (10 weeks)
Title
Assessment of treatment satisfaction - Client Satisfaction Questionnaire-8 (CSQ-8)
Description
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)
Time Frame
8-10 weeks postpartum
Title
Assessment of treatment credibility - Treatment Credibility Scale (TCS)
Description
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.
Time Frame
Treatment week 2
Title
Assessment of treatment credibility - Treatment Credibility Scale (TCS)
Description
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.
Time Frame
Treatment week 4
Title
Assessment of treatment fidelity
Description
Clinician rated structured assessment with instrument developed at the clinic for internet psychiatry.
Time Frame
Post-treatment (10 weeks)
Title
Assessment of maternity health care, birth- and child related health and care outcomes - Swedish pregnancy and medical birth registers.
Description
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.
Time Frame
Pregnancy to 8-10 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Bendix, PhD
Phone
+46 73 6370 864
Email
marie.bendix@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Bendix, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Bendix, PhD
Phone
+46 73 637 0864
Email
marie.bendix@ki.se
12. IPD Sharing Statement
Citations:
PubMed Identifier
28628768
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.
Results Reference
background
Links:
URL
https://dana.ki.se
Description
The homepage for the study where patients can register
URL
https://www.internetpsykiatri.se/behandling/depression-under-graviditeten-studie/
Description
The public webpage of the Internet Psychiatry Clinic
Learn more about this trial
Internet CBT for Antenatal Depression
We'll reach out to this number within 24 hrs