E-health Cognitive Behavioral Therapy in Women Treated by in Vitro Fertilization (IVF)
|ClinicalTrials.gov Identifier: NCT01283607|
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : November 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Anxiety Infertility||Behavioral: Digicoach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Treatment of Depression and Anxiety by an E-health Cognitive Behavioral Therapy (Digicoach) in Women Treated by in Vitro Fertilization (IVF)|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Active Comparator: 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 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.
No Intervention: Control
Women in the control group will get the usual treatment, there will be no additional intervention.
- scores on anxiety and depression [ Time Frame: 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.
- (para)medical consumption [ Time Frame: during the IVF cycle ]by questionnaires
- process evaluation of the webbased cognitive behavioral therapy (CBT) [ Time Frame: 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 [ Time Frame: during the IVF cycle ]by questionnaires
- health related quality of life [ Time Frame: 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 [ Time Frame: three weeks after the IVF cycle ]by questionnaire and medical record viewing
- economical evaluation [ Time Frame: three months after the IVF cycle ]cost effectiveness of the e-health cognitive behavioral therapy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283607
|Radboud University Nijmegen Medical Centre, department of obstetrics and gynecology|
|Study Director:||Jan A Kremer, Ph.D. M.D.||Radboud University|
|Study Chair:||Chris M Verhaak, Ph.D.||Radboud University|
|Study Chair:||Willianne L Nelen, Ph.D. M.D.||Radboud University|