Anxiety, Depression, Infertility
Conditions
Keywords
in vitro fertilization, e-health, cognitive behavioral therapy, psychosocial risk profile, emotional maladjustment
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.
Interventions
BEHAVIORALDigicoach
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.
Sponsors
Stichting Nuts Ohra
University Medical Center Nijmegen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| (para)medical consumption | during the IVF cycle | by questionnaires |
| 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 |
| 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 |
Countries
Netherlands
Outcome results
None listed