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Involuntary Childlessness and Stress Management

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01187095
Enrollment
298
Registered
2010-08-23
Start date
2010-11-30
Completion date
2012-12-31
Last updated
2021-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Involuntary childlessness, Infertility, IVF, EWI, Couples in IVF treatment, Psychosocial intervention

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: 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.

Interventions

BEHAVIORALExpressive writing

3 consecutive days of writing

BEHAVIORALActive ctrl

Control

Sponsors

Aarhus University Hospital
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* heterosexual couples lesbian couples

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The Effect of Expressive Writing Intervention on Fertility Related Stressfollow-up 2 (3 months)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

MeasureTime frameDescription
Pregnancy Ratemeasured at follow-up (t3) 3 monthsHow many women achieved pregnancy in each arm

Countries

Denmark

Participant flow

Recruitment details

Couples were recruited from November 2010 through July 2012. Recruitment took place at the following three Danish fertility clinics: The Fertility Clinic at Aarhus University Hospital, Skive Fertility Clinic, Skive; Brædstrup Fertility Clinic, Brædstrup.

Participants by arm

ArmCount
Counselling
Does couples in IVF treatment benefit from emotional disclosure Expressive writing: 3 consecutive days of writing
153
Control
Neutral writing exercise Active ctrl: Control
142
Total295

Baseline characteristics

CharacteristicCounsellingControlTotal
Age, Continuous
Partners
33.9 years
STANDARD_DEVIATION 5.9
34.7 years
STANDARD_DEVIATION 6.2
34.3 years
STANDARD_DEVIATION 6
Age, Continuous
Women
31.9 years
STANDARD_DEVIATION 4.4
32.9 years
STANDARD_DEVIATION 4.8
32.3 years
STANDARD_DEVIATION 4.5
Region of Enrollment
Denmark
153 Participants142 Participants295 Participants
Sex: Female, Male
Female
83 Participants80 Participants163 Participants
Sex: Female, Male
Male
70 Participants62 Participants132 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1080 / 108
other
Total, other adverse events
0 / 1080 / 108
serious
Total, serious adverse events
0 / 1080 / 108

Outcome results

Primary

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.

Time frame: follow-up 2 (3 months)

Population: Couples undergoing IVF or ICSI fertility treatment

ArmMeasureGroupValue (MEAN)Dispersion
CounsellingThe Effect of Expressive Writing Intervention on Fertility Related StressBaseline17.2 units on a scaleStandard Deviation 9
CounsellingThe Effect of Expressive Writing Intervention on Fertility Related StressFollow up 117.4 units on a scaleStandard Deviation 10.2
CounsellingThe Effect of Expressive Writing Intervention on Fertility Related StressFollow up 218.7 units on a scaleStandard Deviation 9.5
ControlThe Effect of Expressive Writing Intervention on Fertility Related StressBaseline15.7 units on a scaleStandard Deviation 9.1
ControlThe Effect of Expressive Writing Intervention on Fertility Related StressFollow up 117.1 units on a scaleStandard Deviation 9.8
ControlThe Effect of Expressive Writing Intervention on Fertility Related StressFollow up 217.6 units on a scaleStandard Deviation 10.1
p-value: <0.05Mixed Models Analysis
p-value: <0.05Regression, Logistic
Secondary

Pregnancy Rate

How many women achieved pregnancy in each arm

Time frame: measured at follow-up (t3) 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CounsellingPregnancy Rate42 Participants
ControlPregnancy Rate39 Participants

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026