Infertility, Female Clinical Trial
Official title:
Testing a New Self-help Intervention for Infertility Related Distress: a Pilot Study
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Regina | Regina | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Regina |
Canada,
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) |
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