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

NCT01283607 | Completed DMC

• 1 other identifier: Digicoach
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Depression; Anxiety; Infertility

Keywords

in vitro fertilization; e-health; cognitive behavioral therapy; psychosocial risk profile; emotional maladjustment

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• (para)medical consumption

  during the IVF cycle

• process evaluation of the webbased cognitive behavioral therapy (CBT)

  after the IVF cycle

• productivity loss

  during the IVF cycle

• health related quality of life

  before, during, three weeks and three months after the IVF cycle

• IVF outcome

  three weeks after the IVF cycle

Study Arms (2)

Digicoach

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Women in the control group will get the usual treatment, there will be no additional intervention.

Interventions

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.

Digicoach

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women screened as 'at risk' for emotional maladjustment after In vitro fertilization (IVF) by a screening tool

You may not qualify if:

• impossibility to use Internet
• impossibility to write or read the Dutch language
• high screening scores requiring immediate intervention

Sponsors & Collaborators

• University Medical Center Nijmegen: lead
• Stichting Nuts Ohra: collaborator

Study Sites (1)

Radboud University Nijmegen Medical Centre, department of obstetrics and gynecology

Nijmegen, Nijmegen, Netherlands

Location

Related Publications (3)

• 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. doi: 10.1093/humrep/dei015. Epub 2005 Apr 7.

  PMID: 15817584 BACKGROUND

• 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.

  PMID: 20228392 BACKGROUND

• van Dongen AJ, Nelen WL, IntHout J, Kremer JA, Verhaak CM. e-Therapy to reduce emotional distress in women undergoing assisted reproductive technology (ART): a feasibility randomized controlled trial. Hum Reprod. 2016 May;31(5):1046-57. doi: 10.1093/humrep/dew040. Epub 2016 Mar 10.

  PMID: 26965429 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Infertility

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Genital Diseases; Urogenital Diseases

Study Officials

• Jan A Kremer, Ph.D. M.D.

  Radboud University Medical Center

  STUDY DIRECTOR

• Chris M Verhaak, Ph.D.

  Radboud University Medical Center

  STUDY CHAIR

• Willianne L Nelen, Ph.D. M.D.

  Radboud University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 26, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 18, 2013

Record last verified: 2013-11

Locations

NL (1)