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

University Medical Center Nijmegen

Status: Completed

Conditions: Infertility; Depression; Anxiety

Treatments: Behavioral: Digicoach

Study type: Interventional

Funder types: Other

Identifiers

NCT01283607

Digicoach

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Digicoach

Active Comparator group

Description:

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.

Treatment:

Behavioral: Digicoach

Control

No Intervention group

Description:

Women in the control group will get the usual treatment, there will be no additional intervention.