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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283607
• Other study ID #: Digicoach
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: November 14, 2013
• Start date: February 2011
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: University Medical Center Nijmegen
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: UMC St Radboud, department of obstetrics and gynecology
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Infertility

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre, department of obstetrics and gynecology	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Nijmegen	Stichting Nuts Ohra

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Verhaak CM, Lintsen AM, Evers AW, Braat DD. Who is at risk of emotional problems and how do you know? Screening of women going for IVF treatment. Hum Reprod. 2010 May;25(5):1234-40. doi: 10.1093/humrep/deq054. Epub 2010 Mar 13. — View Citation

Verhaak CM, Smeenk JM, van Minnen A, Kremer JA, Kraaimaat FW. A longitudinal, prospective study on emotional adjustment before, during and after consecutive fertility treatment cycles. Hum Reprod. 2005 Aug;20(8):2253-60. Epub 2005 Apr 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scores on anxiety and depression	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.	three months after an in vitro fertilization (IVF) cycle.	No
Secondary	(para)medical consumption	by questionnaires	during the IVF cycle	No
Secondary	process evaluation of the webbased cognitive behavioral therapy (CBT)	process evaluation will be investigated by the individual's use of Digicoach (page view registration) and the patients' and professionals' experiences with Digicoach (questionnaires).	after the IVF cycle	No
Secondary	productivity loss	by questionnaires	during the IVF cycle	No
Secondary	health related quality of life	by questionnaire using FertiQol (Fertility Quality of Life questionnaire), a validated screening instrument measuring quality of life related to fertility treatment	before, during, three weeks and three months after the IVF cycle	No
Secondary	IVF outcome	by questionnaire and medical record viewing	three weeks after the IVF cycle	No
Secondary	economical evaluation	cost effectiveness of the e-health cognitive behavioral therapy	three months after the IVF cycle	No