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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility, Female

Intervention / Treatment
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* Behavioral: Coping with Infertility Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coping with Infertility Program<br>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. | Behavioral: Coping with Infertility Program<br>* 6 10-minute videos with assigned homework<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility-related distress, depression, anxiety