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Completed

NCT Number: NCT01283607

E-health Cognitive Behavioral Therapy 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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Genital Diseases Infertility Mental Disorders Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre, department of obstetrics and gynecology

Nijmegen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digicoach

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. (para)medical consumption

    Time frame: during the IVF cycle

    by questionnaires

  2. 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).

  3. productivity loss

    Time frame: during the IVF cycle

    by questionnaires

  4. 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

  5. IVF outcome

    Time frame: three weeks after the IVF cycle

    by questionnaire and medical record viewing

  6. economical evaluation

    Time frame: three months after the IVF cycle

    cost effectiveness of the e-health cognitive behavioral therapy

Sponsors and collaborators

Lead sponsor

University Medical Center Nijmegen

Other

Collaborators

  • Stichting Nuts Ohra

Registry information

Official study title

Treatment of Depression and Anxiety by an E-health Cognitive Behavioral Therapy (Digicoach) in Women Treated by in Vitro Fertilization (IVF)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 26, 2011
Registry last updated
Nov 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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