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

Tracking Information

First Received Date ^ICMJE

January 21, 2011

Last Updated Date

March 12, 2013

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01283607 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

(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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Depression
Anxiety
Infertility

Intervention ^ICMJE

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.

Study Arm (s)

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.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

October 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 42 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Angelique J van Dongen, M.D.

+31 24 3614748

a.vandongen@obgyn.umcn.nl

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01283607

Other Study ID Numbers ^ICMJE

Digicoach

Has Data Monitoring Committee

Yes

Responsible Party

Angelique van Dongen, University Medical Center Nijmegen

Study Sponsor ^ICMJE

University Medical Center Nijmegen

Collaborators ^ICMJE

Stichting Nuts Ohra

Investigators ^ICMJE

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

Information Provided By

University Medical Center Nijmegen

Verification Date

March 2013

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

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