E-health Cognitive Behavioral Therapy in Women Treated by in Vitro Fertilization (IVF)
NCT ID: NCT01283607
Last Updated: 2013-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2011-02-28
2013-07-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
Control
Women in the control group will get the usual treatment, there will be no additional intervention.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* impossibility to write or read the Dutch language
* high screening scores requiring immediate intervention
18 Years
42 Years
FEMALE
No
Sponsors
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Stichting Nuts Ohra
OTHER
University Medical Center Nijmegen
OTHER
Responsible Party
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Angelique van Dongen
MD
Principal Investigators
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Jan A Kremer, Ph.D. M.D.
Role: STUDY_DIRECTOR
Radboud University Medical Center
Chris M Verhaak, Ph.D.
Role: STUDY_CHAIR
Radboud University Medical Center
Willianne L Nelen, Ph.D. M.D.
Role: STUDY_CHAIR
Radboud University Medical Center
Locations
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Radboud University Nijmegen Medical Centre, department of obstetrics and gynecology
Nijmegen, Nijmegen, Netherlands
Countries
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References
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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.
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.
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.
Other Identifiers
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Digicoach
Identifier Type: -
Identifier Source: org_study_id