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

Not Applicable

Completed

• Conditions: Depression; Anxiety; Infertility
• Interventions: Behavioral: Digicoach

• Registration Number: NCT01283607
• Lead Sponsor: University Medical Center Nijmegen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-26
• Study Start: 2011-02
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• women screened as 'at risk' for emotional maladjustment after In vitro fertilization (IVF) by a screening tool

Exclusion Criteria

• impossibility to use Internet
• impossibility to write or read the Dutch language
• high screening scores requiring immediate intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digicoach	Digicoach	Women randomized in the Digicoach group will be treated by the Digicoach therapy. Digicoach is an e-health cognitive behavioral therapy with 4-12 weekly sessions especially developed for in vitro fertilization (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.

Primary Outcome Measures

Name	Time	Method
scores on anxiety and depression	three months after an in vitro fertilization (IVF) cycle.	anxiety and depression rates three weeks after an unsuccessful IVF cycle, scored by the Hospitality Anxiety Depression Scale (HADS), we also measure the scores during the IVF cycle and three months after the IVF cycle.

Secondary Outcome Measures

Name	Time	Method
process evaluation of the webbased cognitive behavioral therapy (CBT)	after the IVF cycle	process evaluation will be investigated by the individual's use of Digicoach (page view registration) and the patients' and professionals' experiences with Digicoach (questionnaires).
productivity loss	during the IVF cycle	by questionnaires
health related quality of life	before, during, three weeks and three months after the IVF cycle	by questionnaire using FertiQol (Fertility Quality of Life questionnaire), a validated screening instrument measuring quality of life related to fertility treatment
IVF outcome	three weeks after the IVF cycle	by questionnaire and medical record viewing
economical evaluation	three months after the IVF cycle	cost effectiveness of the e-health cognitive behavioral therapy
(para)medical consumption	during the IVF cycle	by questionnaires

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre, department of obstetrics and gynecology; 🇳🇱 Nijmegen, Netherlands