Infertility, Female
Conditions
Brief summary
This RCT will test the effect of a 7-week self-help ACT-based program in improving fertility-related quality of life and psychological flexibility, in women with infertility.
Detailed description
Ninety women with infertility living in Canada and the United States will be recruited. They will be emailed seven weekly 15-minute videos, each providing instructions on a new Acceptance and Commitment Therapy-based technique that addresses the impact of infertility on psychological inflexibility and distress. Fertility-related quality of life and psychological flexibility will be measured before and after the program. Outcomes will also be measured at one-month follow-up. Feedback about how to improve the program will also be collected.
Interventions
BEHAVIORALInfertility ACTion Program
Seven 15-minutes videos of Acceptance and commitment therapy adapted for women with infertility with assigned homework and summaries of the videos.
Sponsors
University of Regina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinding will not be implemented as condition assignment through randomization will be obvious to both the participants and the primary investigator. Participants will be provided with an introduction and rationale for the respective condition they are assigned to. Participants in the waitlist control condition will be given the opportunity to enroll in the intervention after completing the follow-up measures.
Intervention model description
Eligible participants will be randomized either to the ACT conditions or to the waitlist control condition. Randomization will occur using a 1:1 allocation ratio and random block sizes to ensure comparable condition sizes while minimizing the ability to predict condition assignment.
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 * Lives in Canada or the United States * Reports a high level of distress related to infertility, as indicated by a FertiQoL score below 71
Exclusion criteria
* Is currently experiencing active suicidal ideation, as indicated by a score of 7 or above on the Suicide Behaviours Questionnaire - Revised (SBQ-R)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fertility Quality of Life tool (Fertiqol) | Pre-to-post intervention change and in the month following the intervention (post measures assessed 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. |
| Psychological flexibility (MPFI) | Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module) | Pre-to-post change in psychological flexibility. Higher scores on the flexibility sub scale indicating better psychological flexibility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder-7 (GAD-7) | Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module) | Pre-to-post change in anxious symptoms; Scores range from 0-21, with higher scoresindicating more severe anxiety |
| Patient Health Questionnaire-9 (PHQ-9) | Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module) | Pre-to-post change in depressive symptoms; Scores range from 0-27, with higherscores indicating more severe depressive symptoms |
Countries
Canada
Outcome results
None listed