Involuntary Childlessness and Stress Management

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Yoon Frederiksen, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01187095
First received: July 9, 2010
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

Many couples experience involuntary childlessness and seek treatment at fertility clinics. Going through treatment procedures can be very challenging, time consuming and emotionally demanding.

Psychosocial intervention might have a soothing and healing effect on both behavior as well on physical matters. Hence, the investigators would like to investigate whether Expressive Writing Intervention (EWI) has an effect on stress management as well as on the pregnancy rate for couples who are going through fertility treatment.


Condition Intervention
Infertility
Behavioral: Expressive writing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Intervention Study: The Effect of Expressive Writing on Psychosocial Stress and Pregnancy Results With Couples Undergoing In Vitro Fertility(IVF) Treatment Due to Involuntary Childlessness.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • The effect of expressive writing intervention on fertility related stress [ Time Frame: follow-up 2 (3 months) ] [ Designated as safety issue: No ]
    measured by COMPII and FPI questionaires developed to measure fertility related stress


Secondary Outcome Measures:
  • The effect of expressive writing intervention on pregnancy - if any? [ Time Frame: measured at follow up 2 (3 months) ] [ Designated as safety issue: No ]

Enrollment: 298
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: counselling
Does couples in IVF treatment benefit from emotional disclosure
Behavioral: Expressive writing
3 consecutive days of writing
Other Name: EWI

Detailed Description:

Background:

Around 10-14 % of all couples are experiencing involuntary childlessness. Most of these couples will be referred to the public health clinics in order to receive help by means of fertility treatment e.g. in vitro fertility (IVF) and numbers from the National board of Health indicates that the number is rising. It is well known that involuntary childlessness pose an enduring psychosocial burden and strain with feelings of hopelessness, despair, anger and frustration as well as anxiety and sadness. Much research points out that couples that receive IVF treatment to a great extent often experience stress and strong emotional oscillations during the treatment procedures. Some studies indicate that negative feelings as described above might have a negative impact on the chances of becoming pregnant. In spite of these findings there are only conducted very few controlled studies of intervention with this patient group, which might explain why it is still unclear whether infertile couples can benefit from therapeutic intervention.

A growing number of studies in the area of health psychology has suggested that interventions where the participants has the opportunity to express themselves in writing about feelings, so-called Expressive Writing Intervention (EWI) seem to have a positive effect on physical health as well as mental well-being.

Methods:

Couples starting with their IVF treatment at the Fertility Clinic, Skejby Hospital will be invited to participate in the research project. Approximately 400 couples are expected to begin treatment during a one year period (We would like to enrol at least 144 couples). They will be randomized into a EWI group (writing about fertility related topics - emotional disclosure) and a control group (writing about neutral topics non-emotional disclosure).

Inclusion criteria:

  • Heterosexual couples as well as Homosexual couples
  • 1st, 2nd and 3rd treatment cycles
  • Can read and understand Danish
  • Aged 18-40 years

Exclusion criteria:

• Patients with genetic diseases (PGD patients)

The investigators would like to know more about whether EWI has an effect on:

  1. The extent of psychosocial strain - does change happen in life satisfaction, emotional state and reactions, as well as with thoughts about childlessness and treatment.
  2. The result of the IVF treatment (pregnancy/non pregnancy)
  3. The adaptation to the (negative) treatment outcome - the impact of having participated in an EWI intervention group.

Furthermore mediators and moderators will be explored.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • heterosexual couples lesbian couples

Exclusion Criteria:

  • couples; where one of them suffers from a genetic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187095

Locations
Denmark
Department of Psychology, Aarhus University
Aarhus, Jylland, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Bobby Zachariae, prof.med., Department of Psychology, Aarhus University
  More Information

No publications provided

Responsible Party: Yoon Frederiksen, PhD.-fellowship, University of Aarhus
ClinicalTrials.gov Identifier: NCT01187095     History of Changes
Other Study ID Numbers: EWI-2008-41-1869
Study First Received: July 9, 2010
Last Updated: February 27, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Involuntary childlessness
Infertility
IVF
EWI
Couples in IVF treatment
Psychosocial intervention

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 29, 2014