NCT05103982

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

October 20, 2021

Last Update Submit

January 31, 2022

Conditions

Infertility, Female

Keywords

infertility-related distressdepressionanxiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)

  • 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)

Study Arms (1)

Coping with Infertility Program

EXPERIMENTAL

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

Interventions

Coping with Infertility ProgramBEHAVIORAL

6 10-minute videos with assigned homework

Coping with Infertility Program

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

RECRUITING

Related Publications (1)

  • Poulter MML, Balsom AA, Gordon JL. Pilot trial of a new self-directed psychological intervention for infertility-related distress. Pilot Feasibility Stud. 2024 Aug 16;10(1):111. doi: 10.1186/s40814-024-01535-y.

    PMID: 39152484DERIVED

MeSH Terms

Conditions

Infertility, FemaleDepressionAnxiety Disorders

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Jennifer L Gordon, PhD

CONTACT

3063514976jennifer.gordon@uregina.ca

Andreea Ababei, BA

CONTACT

3065854992wmh.research@uregina.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 2, 2021

Study Start

November 1, 2021

Primary Completion

March 1, 2022

Study Completion

April 15, 2022

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)