Testing a New Self-help Intervention for Infertility Related Distress: a Pilot Study

Infertility, Female Clinical Trial

Official title:

Testing a New Self-help Intervention for Infertility Related Distress: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103982
• Other study ID #: 2021-108
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: January 2022
• Source: University of Regina
• Contact: Jennifer L Gordon, PhD
• Phone: 3063514976
• Email: jennifer.gordon[@]uregina.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study will test the effect of a 6-week self-help program in improving fertility-related quality of life as well as anxious and depressive symptoms, in women with infertility.

Description:

Twenty women with infertility living in Saskatchewan will be recruited and will be emailed six weekly 10-minute videos, each providing instructions on a new psychological technique that is aimed at addressing the emotional and interpersonal challenges of infertility. Fertility-related quality of life, depressive symptoms, and anxious symptoms will be measured before and after the program. Outcomes will also be measured weekly for three weeks post-intervention. Feedback about how to improve the program will also be collected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 15, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• Has been trying to get pregnant for 12+ months and has failed OR is currently undergoing fertility treatments due to a diagnosis of infertility

• Lives in Saskatchewan, Canada

• Reports a high level of distress related to infertility, as indicated by a FertiQoL score below 52 or at least mild anxious or depressive symptoms (GAD-7 score of 5 or above or PHQ-9 score of 5 or above)

Exclusion Criteria:

• Has a history of suicide attempts

• Is currently experiencing suicidal ideation

• Reports severe depressive symptoms, as indicated by a PHQ-9 score above 19

• Reports severe anxious symptoms, as indicated by a GAD-7 score above 14

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Behavioral:
• Coping with Infertility Program
6 10-minute videos with assigned homework

Locations

Country	Name	City	State
Canada	University of Regina	Regina	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Regina

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertility Quality of Life tool (Fertiqol)	Pre-to-post change in quality of life related to a diagnosis of infertility. Scores range from 0-100, with higher scores indicating better quality of life	Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	Pre-to-post change in anxious symptoms; Scores range from 0-21, with higher scores indicating more severe anxiety	Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Pre-to-post change in depressive symptoms; Scores range from 0-27, with higher scores indicating more severe depressive symptoms	Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)