ICBT for Antenatal Depression

September 2, 2016 updated by: Viktor Kaldo, Karolinska Institutet

Psychological Treatment Via the Internet for Antenatal Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICBT
Internet-based CBT for antenatal depression
Behavioral: ICBT for antenatal depression
Participants receives active therapist support via the internet to go through a 10-week self-help treatment on a secure web platform
Active Comparator: TAU
Treatment as usual provided at antenatal clinics and other health care instances
Other: TAU
Treatment as usual provided at antenatal clinics and other health care instances

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-rated depression measured by Montgomery Asberg Depression Rating Scale
Time Frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
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.
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-rated antenatal depression Edinburgh Postnatal Depression Scale
Time Frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Edinburgh Postnatal Depression Scale (EPDS; Cox, Holden & Sagovsky, 1987)
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Self-rated function Work and Social Adjustment Scale
Time Frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Work and Social Adjustment Scale (WSAS; Zahra et al., 2014)
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Self-rated Insomnia Insomnia Severity Index
Time Frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Insomnia Severity Index (ISI; Bastien, Vallieres & Morin, 2001)
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Self-rated function/quality of life Euroqol
Time Frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Euroqol (EQ-5D ; Hinz et al., 2006),
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Self-rated anxiety and worry GAD-7
Time Frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
GAD-7(Beard, & Björgvinsson, 2014)
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Expert rating of overall disease burden Clinical Global Impression - Severity scale
Time Frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Clinical Global Impression - Severity scale (CGI-S; Guy, 2000)
Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 18, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20141959311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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