Clinical trial NCT01283607: E-health Cognitive Behavioral Therapy in Women Treated by in Vitro Fertilization (IVF)
Official title: Treatment of Depression and Anxiety by an E-health Cognitive Behavioral Therapy (Digicoach) in Women Treated by in Vitro Fertilization (IVF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Infertility
Keywords: in vitro fertilization
e-health
cognitive behavioral therapy
psychosocial risk profile
emotional maladjustment
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
Collaborators: name: Stichting Nuts Ohra
First posted: 2011-01-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: scores on anxiety and depression
timeFrame: three months after an in vitro fertilization (IVF) cycle.
Secondary outcomes:
measure: (para)medical consumption
timeFrame: during the IVF cycle
measure: process evaluation of the webbased cognitive behavioral therapy (CBT)
timeFrame: after the IVF cycle
measure: productivity loss
timeFrame: during the IVF cycle
measure: health related quality of life
timeFrame: before, during, three weeks and three months after the IVF cycle
measure: IVF outcome
timeFrame: three weeks after the IVF cycle
measure: economical evaluation
timeFrame: three months after the IVF cycle
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre, department of obstetrics and gynecology
Study officials:
affiliation: Radboud University Medical Center
name: Jan A Kremer, Ph.D. M.D.
role: STUDY_DIRECTOR
affiliation: Radboud University Medical Center
name: Chris M Verhaak, Ph.D.
role: STUDY_CHAIR
affiliation: Radboud University Medical Center
name: Willianne L Nelen, Ph.D. M.D.
role: STUDY_CHAIR
References:
citation: Verhaak CM, Smeenk JM, van Minnen A, Kremer JA, Kraaimaat FW. A longitudinal, prospective study on emotional adjustment before, during and after consecutive fertility treatment cycles. Hum Reprod. 2005 Aug;20(8):2253-60. doi: 10.1093/humrep/dei015. Epub 2005 Apr 7.
citation: Verhaak CM, Lintsen AM, Evers AW, Braat DD. Who is at risk of emotional problems and how do you know? Screening of women going for IVF treatment. Hum Reprod. 2010 May;25(5):1234-40. doi: 10.1093/humrep/deq054. Epub 2010 Mar 13.
citation: van Dongen AJ, Nelen WL, IntHout J, Kremer JA, Verhaak CM. e-Therapy to reduce emotional distress in women undergoing assisted reproductive technology (ART): a feasibility randomized controlled trial. Hum Reprod. 2016 May;31(5):1046-57. doi: 10.1093/humrep/dew040. Epub 2016 Mar 10.