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

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05103982
Enrollment
20
Registered
2021-11-02
Start date
2021-11-01
Completion date
2022-04-15
Last updated
2022-02-01

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

Conditions

Infertility, Female

Keywords

infertility-related distress, depression, anxiety

Brief 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.

Detailed 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.

Interventions

BEHAVIORALCoping with Infertility Program

6 10-minute videos with assigned homework

Sponsors

University of Regina
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fertility Quality of Life tool (Fertiqol)Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)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

Secondary

MeasureTime frameDescription
Generalized Anxiety Disorder-7 (GAD-7)Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)Pre-to-post change in anxious symptoms; Scores range from 0-21, with higher scores indicating more severe anxiety
Patient Health Questionnaire-9 (PHQ-9)Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)Pre-to-post change in depressive symptoms; Scores range from 0-27, with higher scores indicating more severe depressive symptoms

Countries

Canada

Contacts

Primary ContactJennifer L Gordon, PhD
jennifer.gordon@uregina.ca3063514976
Backup ContactAndreea Ababei, BA
wmh.research@uregina.ca3065854992

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026