NCT01283607

E-health Cognitive Behavioral Therapy in Women Treated by in Vitro Fertilization (IVF)

Treatment of Depression and Anxiety by an E-health Cognitive Behavioral Therapy (Digicoach) in Women Treated by in Vitro Fertilization (IVF)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University Medical Center Nijmegen · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Depression
• Anxiety
• Infertility

Interventions

Type	Name	Description
BEHAVIORAL	Digicoach	Digicoach is an e-health cognitive behavioral therapy with 4-12 weekly sessions especially developed for IVF women. Digicoach is facilitated by an e-therapist. The investment for the weekly home work assignments is about one and a half hour. Digicoach consist of different modules (e.g. stress reduction, acceptance). Digicoach starts before the hormonal down regulation as the start of the IVF procedure and ends three weeks after the pregnancy test.

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-01-26
• Last updated: 2013-11-18

Locations

1 site across 1 country: Netherlands