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

This study is currently recruiting participants.
Verified March 2013 by University Medical Center Nijmegen
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: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

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 months 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 Intervention
Depression
Anxiety
Infertility
 Behavioral: Digicoach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Treatment of Depression and Anxiety by an E-health Cognitive Behavioral Therapy (Digicoach) in Women Treated by in Vitro Fertilization (IVF)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Center Nijmegen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • (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


Estimated Enrollment: 120
Study Start Date: February 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
No Intervention: Control
Women in the control group will get the usual treatment, there will be no additional intervention.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283607

Contacts
Contact: Angelique J van Dongen, M.D. +31 24 3614748 a.vandongen@obgyn.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre, department of obstetrics and gynecology Recruiting
Nijmegen, Netherlands
Contact: Angelique J van Dongen, M.D.     +31 24 3614748     a.vandongen@obgyn.umcn.nl    
Sponsors and Collaborators
University Medical Center Nijmegen
Stichting Nuts Ohra
Investigators
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
  More Information

Publications:

Responsible Party: Angelique van Dongen, MD, University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT01283607     History of Changes
Other Study ID Numbers: Digicoach
Study First Received: January 21, 2011
Last Updated: March 12, 2013
Health Authority: The Netherlands: UMC St Radboud, department of obstetrics and gynecology

Keywords provided by University Medical Center Nijmegen:
in vitro fertilization
e-health
cognitive behavioral therapy
psychosocial risk profile
emotional maladjustment

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Infertility
Mental Disorders
 Behavioral Symptoms
Mood Disorders
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013