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

University of Regina

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Infertility, Female

Treatments: Behavioral: Coping with Infertility Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05103982

2021-108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Coping with Infertility Program

Experimental group

Description:

The program consists of brief weekly videos, each addressing a particular psychological technique to be implemented that week. Participants receive the videos by email from the researcher and watch them on their own. Each video also assigns a "homework" exercise for the participant to complete that week.

Treatment:

Behavioral: Coping with Infertility Program