ICBT for Antenatal Depression
Primary Purpose
Antenatal Depression
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ICBT for antenatal depression
TAU
Sponsored by

About this trial
This is an interventional treatment trial for Antenatal Depression
Eligibility Criteria
Inclusion Criteria:
- pregnant female > 18 years old at gestational week 11-28
- verified moderate depression according to SCID-I with or without concomitant anxiety disorder
- able to understand the Swedish language orally and in written
- able to use the internet for the ICBT
- currently in contact with an antenatal clinic to receive regular care
Exclusion Criteria:
- known drug or alcohol abuse
- serious somatic disorder or psychiatric disorder such as psychosis, bipolar disorder, severe personality disorder, autism or mental retardation and severe melancholic or psychotic depression,
- having started or changed medication with SSRI, SNRI or mood-stabilizers within 3 weeks,
- according to psychiatric assessment have a high suicide risk will be excluded from the study. These women will be helped to receive necessary psychiatric treatment as usual.
Sites / Locations
- Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ICBT
TAU
Arm Description
Internet-based CBT for antenatal depression
Treatment as usual provided at antenatal clinics and other health care instances
Outcomes
Primary Outcome Measures
Self-rated depression measured by Montgomery Asberg Depression Rating Scale
Depression measured by Montgomery Asberg Depression Rating Scale (MADRS-S), a 9-item self-rated measure of change in depression severity. It also screens for suicidality.
Secondary Outcome Measures
Self-rated antenatal depression Edinburgh Postnatal Depression Scale
Edinburgh Postnatal Depression Scale (EPDS; Cox, Holden & Sagovsky, 1987)
Self-rated function Work and Social Adjustment Scale
Work and Social Adjustment Scale (WSAS; Zahra et al., 2014)
Self-rated Insomnia Insomnia Severity Index
Insomnia Severity Index (ISI; Bastien, Vallieres & Morin, 2001)
Self-rated function/quality of life Euroqol
Euroqol (EQ-5D ; Hinz et al., 2006),
Self-rated anxiety and worry GAD-7
GAD-7(Beard, & Björgvinsson, 2014)
Expert rating of overall disease burden Clinical Global Impression - Severity scale
Clinical Global Impression - Severity scale (CGI-S; Guy, 2000)
Full Information
NCT ID
NCT02366429
First Posted
February 12, 2015
Last Updated
September 2, 2016
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02366429
Brief Title
ICBT for Antenatal Depression
Official Title
Psychological Treatment Via the Internet for Antenatal Depression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized controlled trial evaluating an Internet-delivered Cognitive Behavioral Therapy (ICBT) adapted for pregnant women suffering from antenatal depression. The ICBT-program will be added to treatment as usual (TAU) and compared to TAU only.
Participants (n=60) are recruited from all over Sweden (only Swedish citizens can participate) and are assessed and treated on a distance via a secure web platform and telephone.
Detailed Description
In order to evaluate feasibility and effectiveness of an ICBT-program for antenatal depression that will be used in a larger clinical trial, the current RCT (n=60) will be performed and act as a pilot for the main study.
Participants will all be receiving the regular treatment (TAU) provided at their antenatal clinic and other health care instances. Half of them will be randomized to an add-on of a previously established 10-week long ICBT-program for depression in general, now adapted for pregnant women. The other half will receive TAU during 10 weeks and then freely decide if they want to participate in the pregnancy-adapted ICBT-program (only possible if 10 or more weeks left till estimated delivery date), start the regular ICBT-program for depression within 2-6 weeks post-partum, or decline ICBT-treatment. The participants in this study will be recruited from all over Sweden via internet, advertisements and information at antenatal clinics. A web-based screening questionnaire will form the basis for a first assessment and review of inclusion criteria, followed by a structured telephone interview where diagnoses (SCID-1 for depression, adjusted for DSM 5, and M.I.N.I. for other diagnoses and assessment of suicide risk) and suitability will be assessed, a CGI-rating will be performed, and the final decision on inclusion will be made.
Level of depression pre- and post-treatment will be assessed with MADRS-S filled out via the internet-treatment platform together with the other self-rating measures used in the main study. A questionnaire where the participants evaluate the content of the adapted ICBT-program and their own use and perceived benefit of the treatment methods will also be given at post-treatment and during treatment.
Structured telephone interview will be held at post-treatment, primarily to assess the content of TAU, to administer CGI and a standardized version for MADRS-S (designed to replace missing questionnaire data), and to make a qualitative evaluation of the participants view of the adapted ICBT-program.
The estimated effect of ICBT compared to TAU is 0.8 (Cohen's d) and with 60 participants and some attrition this will result in a statistical power of 80% for this initial, smaller RCT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antenatal Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICBT
Arm Type
Experimental
Arm Description
Internet-based CBT for antenatal depression
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Treatment as usual provided at antenatal clinics and other health care instances
Intervention Type
Behavioral
Intervention Name(s)
ICBT for antenatal depression
Intervention Description
Participants receives active therapist support via the internet to go through a 10-week self-help treatment on a secure web platform
Intervention Type
Other
Intervention Name(s)
TAU
Intervention Description
Treatment as usual provided at antenatal clinics and other health care instances
Primary Outcome Measure Information:
Title
Self-rated depression measured by Montgomery Asberg Depression Rating Scale
Description
Depression measured by Montgomery Asberg Depression Rating Scale (MADRS-S), a 9-item self-rated measure of change in depression severity. It also screens for suicidality.
Time Frame
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Secondary Outcome Measure Information:
Title
Self-rated antenatal depression Edinburgh Postnatal Depression Scale
Description
Edinburgh Postnatal Depression Scale (EPDS; Cox, Holden & Sagovsky, 1987)
Time Frame
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Title
Self-rated function Work and Social Adjustment Scale
Description
Work and Social Adjustment Scale (WSAS; Zahra et al., 2014)
Time Frame
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Title
Self-rated Insomnia Insomnia Severity Index
Description
Insomnia Severity Index (ISI; Bastien, Vallieres & Morin, 2001)
Time Frame
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Title
Self-rated function/quality of life Euroqol
Description
Euroqol (EQ-5D ; Hinz et al., 2006),
Time Frame
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Title
Self-rated anxiety and worry GAD-7
Description
GAD-7(Beard, & Björgvinsson, 2014)
Time Frame
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Title
Expert rating of overall disease burden Clinical Global Impression - Severity scale
Description
Clinical Global Impression - Severity scale (CGI-S; Guy, 2000)
Time Frame
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant female > 18 years old at gestational week 11-28
verified moderate depression according to SCID-I with or without concomitant anxiety disorder
able to understand the Swedish language orally and in written
able to use the internet for the ICBT
currently in contact with an antenatal clinic to receive regular care
Exclusion Criteria:
known drug or alcohol abuse
serious somatic disorder or psychiatric disorder such as psychosis, bipolar disorder, severe personality disorder, autism or mental retardation and severe melancholic or psychotic depression,
having started or changed medication with SSRI, SNRI or mood-stabilizers within 3 weeks,
according to psychiatric assessment have a high suicide risk will be excluded from the study. These women will be helped to receive necessary psychiatric treatment as usual.
Facility Information:
Facility Name
Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO
City
Stockholm
Country
Sweden
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
derived
Links:
URL
http://www.internetpsykiatri.se
Description
Related Info
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ICBT for Antenatal Depression
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