Depression Clinical Trial
Official title:
Treatment of Depression and Anxiety by an E-health Cognitive Behavioral Therapy (Digicoach) in Women Treated by in Vitro Fertilization (IVF)
Yearly, 15,000 Dutch in vitro fertilization (IVF) cycles are performed for subfertility with
a pregnancy rate of 26%. A failed cycle has great emotional impact; 20-25% of the women has
relevant forms of depression/anxiety even after 6 months. For such maladjustment a risk
profile has been identified and translated into a screening tool. Identification of women at
risk enables a timely and tailored (individual's needs) cognitive behavioral therapy (CBT),
which reduces more serious maladjustment and corresponding costs.
Aim: To investigate the effectiveness of an e-health CBT (digital coaching, Digicoach) in
women ongoing IVF and having been screened at risk.
Design: A single-centered randomised controlled trial comparing Digicoach (intervention)
with standard care (control).
Digicoach: an e-health CBT with 4-12 weekly sessions starting before an IVF cycle, following
a woman's IVF course and covering in modules the main problems: depressed mood, anxiety,
strong focus on child wish and acceptance.
Main outcome measures: anxiety and depression occurrence rate 3 weeks after an unsuccessful
IVF cycle. Secondary outcome measures: 1. (para)medical consumption, 2. quality of life, 3.
productivity loss and 4. IVF outcome. Data are collected by questionnaires, diaries, medical
record audit and page view registrations.
Process evaluation: Individual's use (e.g. module progress, completion rate), experiences,
(e.g. satisfaction and usability) and potential barriers for implementation are evaluated.
Economic evaluation: studied during the Digicoach exposures from a societal perspective.
Incremental costs (costs/%avoidance of depression/anxiety) are determined by comparing both
study groups.
Power/data analysis: To detect a 29% difference in the depression/anxiety occurrence rates
(alfa=0.05 and beta=0.80) 58 unpregnant IVF women are evaluated.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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