ICBT for Antenatal Depression
Condition: Antenatal Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): ICBT for antenatal depression; TAU
Intervention type(s): Behavioral; Other
Intervention description(s): Participants receives active therapist support via the internet to go through a 10-week self-help treatment on a secure web platform; Treatment as usual provided at antenatal clinics and other health care instances
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment