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

This study has been completed.
Sponsor:
Collaborator:
Stichting Nuts Ohra
Information provided by (Responsible Party):
Angelique van Dongen, University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01283607
First received: January 21, 2011
Last updated: November 14, 2013
Last verified: November 2013

January 21, 2011
November 14, 2013
February 2011
July 2013   (final data collection date for primary outcome measure)
scores on anxiety and depression [ Time Frame: three months after an in vitro fertilization (IVF) cycle. ] [ Designated as safety issue: No ]
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.
scores on anxiety and depression [ Time Frame: three months after an in vitro fertilization (IVF) cycle. ] [ Designated as safety issue: No ]
anxiety and depression rates three months after an unsuccessful IVF cycle, scored by the Hospitality Anxiety Depression Scale (HADS), we also measure the scores during the IVF cycle and three weeks after the pregnancy test.
Complete list of historical versions of study NCT01283607 on ClinicalTrials.gov Archive Site
  • (para)medical consumption [ Time Frame: during the IVF cycle ] [ Designated as safety issue: No ]
    by questionnaires
  • process evaluation of the webbased cognitive behavioral therapy (CBT) [ Time Frame: after the IVF cycle ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    by questionnaires
  • health related quality of life [ Time Frame: before, during, three weeks and three months after the IVF cycle ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    by questionnaire and medical record viewing
  • economical evaluation [ Time Frame: three months after the IVF cycle ] [ Designated as safety issue: No ]
    cost effectiveness of the e-health cognitive behavioral therapy
  • (para)medical consumption [ Time Frame: during the IVF cycle ] [ Designated as safety issue: No ]
    by questionnaires
  • process evaluation of the webbased cognitive behavioral therapy (CBT) [ Time Frame: after the IVF cycle ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    by questionnaires
  • health related quality of life [ Time Frame: before, during, three weeks and three months after the IVF cycle ] [ Designated as safety issue: No ]
    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 months after the IVF cycle ] [ Designated as safety issue: No ]
    by questionnaire and medical record viewing
  • economical evaluation [ Time Frame: three months after the IVF cycle ] [ Designated as safety issue: No ]
    cost effectiveness of the e-health cognitive behavioral therapy
Not Provided
Not Provided
 
E-health Cognitive Behavioral Therapy in Women Treated by in Vitro Fertilization (IVF)
Treatment of Depression and Anxiety by an E-health Cognitive Behavioral Therapy (Digicoach) in Women Treated by in Vitro Fertilization (IVF)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • Depression
  • Anxiety
  • Infertility
Behavioral: 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.
  • 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.
    Intervention: Behavioral: Digicoach
  • No Intervention: Control
    Women in the control group will get the usual treatment, there will be no additional intervention.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 42 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01283607
Digicoach
Yes
Angelique van Dongen, University Medical Center Nijmegen
University Medical Center Nijmegen
Stichting Nuts Ohra
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
University Medical Center Nijmegen
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP