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Involuntary Childlessness and Stress Management

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Expressive writing
Active ctrl
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility focused on measuring Involuntary childlessness, Infertility, IVF, EWI, Couples in IVF treatment, Psychosocial intervention

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • heterosexual couples lesbian couples

Exclusion Criteria:

  • couples; where one of them suffers from a genetic disease

Sites / Locations

  • Department of Psychology, Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

counselling

Control

Arm Description

Does couples in IVF treatment benefit from emotional disclosure

Neutral writing exercise

Outcomes

Primary Outcome Measures

The Effect of Expressive Writing Intervention on Fertility Related Stress
The COMPI 14-item self-rating instrument has been developed to capture specific thoughts and feelings in relation to involuntarily childlessness, which may lead to distress on 4-point and 5-point Likert scales. Responses cover personal, social, and marital domains with total scores ranging between 14 - 38, and higher scores indicating higher levels of infertility-related distress. Internal consistency (Cronbach's alpha) in the present study was 0.89 and the baseline to post-intervention test-retest correlation was 0.84. For the sub-domains the reliability of the scales were as follows; personal domain α=0.86, social domain α=0.83 and marital domain α=0.73.

Secondary Outcome Measures

Pregnancy Rate
How many women achieved pregnancy in each arm

Full Information

First Posted
July 9, 2010
Last Updated
June 14, 2021
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01187095
Brief Title
Involuntary Childlessness and Stress Management
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: The extent of psychosocial strain - does change happen in life satisfaction, emotional state and reactions, as well as with thoughts about childlessness and treatment. The result of the IVF treatment (pregnancy/non pregnancy) The adaptation to the (negative) treatment outcome - the impact of having participated in an EWI intervention group. Furthermore mediators and moderators will be explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Involuntary childlessness, Infertility, IVF, EWI, Couples in IVF treatment, Psychosocial intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
counselling
Arm Type
Experimental
Arm Description
Does couples in IVF treatment benefit from emotional disclosure
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Neutral writing exercise
Intervention Type
Behavioral
Intervention Name(s)
Expressive writing
Other Intervention Name(s)
EWI
Intervention Description
3 consecutive days of writing
Intervention Type
Behavioral
Intervention Name(s)
Active ctrl
Intervention Description
Control
Primary Outcome Measure Information:
Title
The Effect of Expressive Writing Intervention on Fertility Related Stress
Description
The COMPI 14-item self-rating instrument has been developed to capture specific thoughts and feelings in relation to involuntarily childlessness, which may lead to distress on 4-point and 5-point Likert scales. Responses cover personal, social, and marital domains with total scores ranging between 14 - 38, and higher scores indicating higher levels of infertility-related distress. Internal consistency (Cronbach's alpha) in the present study was 0.89 and the baseline to post-intervention test-retest correlation was 0.84. For the sub-domains the reliability of the scales were as follows; personal domain α=0.86, social domain α=0.83 and marital domain α=0.73.
Time Frame
follow-up 2 (3 months)
Secondary Outcome Measure Information:
Title
Pregnancy Rate
Description
How many women achieved pregnancy in each arm
Time Frame
measured at follow-up (t3) 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: heterosexual couples lesbian couples Exclusion Criteria: couples; where one of them suffers from a genetic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bobby Zachariae, prof.med.,
Organizational Affiliation
Department of Psychology, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, Aarhus University
City
Aarhus
State/Province
Jylland
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34949542
Citation
Philipsen MT, Knudsen UB, Zachariae R, Ingerslev HJ, Hvidt JEM, Frederiksen Y. Sleep, psychological distress, and clinical pregnancy outcome in women and their partners undergoing in vitro or intracytoplasmic sperm injection fertility treatment. Sleep Health. 2022 Apr;8(2):242-248. doi: 10.1016/j.sleh.2021.10.011. Epub 2021 Dec 20.
Results Reference
derived
PubMed Identifier
28007790
Citation
Frederiksen Y, O'Toole MS, Mehlsen MY, Hauge B, Elbaek HO, Zachariae R, Ingerslev HJ. The effect of expressive writing intervention for infertile couples: a randomized controlled trial. Hum Reprod. 2017 Feb;32(2):391-402. doi: 10.1093/humrep/dew320. Epub 2016 Dec 21.
Results Reference
derived

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Involuntary Childlessness and Stress Management

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