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

Primary Purpose

Infertility, Female

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Coping with Infertility Program
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring infertility-related distress, depression, anxiety

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • University of ReginaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coping with Infertility Program

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
October 20, 2021
Last Updated
January 31, 2022
Sponsor
University of Regina
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1. Study Identification

Unique Protocol Identification Number
NCT05103982
Brief Title
Testing a New Self-help Intervention for Infertility Related Distress: a Pilot Study
Official Title
Testing a New Self-help Intervention for Infertility Related Distress: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
April 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
infertility-related distress, depression, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coping with Infertility Program
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Coping with Infertility Program
Intervention Description
6 10-minute videos with assigned homework
Primary Outcome Measure Information:
Title
Fertility Quality of Life tool (Fertiqol)
Description
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
Time Frame
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 Measure Information:
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
Pre-to-post change in anxious symptoms; Scores range from 0-21, with higher scores indicating more severe anxiety
Time Frame
Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
Pre-to-post change in depressive symptoms; Scores range from 0-27, with higher scores indicating more severe depressive symptoms
Time Frame
Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Gordon, PhD
Phone
3063514976
Email
jennifer.gordon@uregina.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Andreea Ababei, BA
Phone
3065854992
Email
wmh.research@uregina.ca
Facility Information:
Facility Name
University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Gordon, PhD
Phone
306-351-4976
Email
jennifer.gordon@uregina.ca
First Name & Middle Initial & Last Name & Degree
Andreea Ababei
Email
wmh.research@uregina.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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