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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The program consists of brief weekly videos, each addressing a particular Acceptance and Commitment Therapy 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 and includes a summary of the module. |
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| Waistlist | No Intervention | Participants in the waitlist control condition will complete the same measures as the intervention group. After they have completed their one-month follow-up measures they will be given the opportunity to receive the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infertility ACTion Program | Behavioral | Seven 15-minutes videos of Acceptance and commitment therapy adapted for women with infertility with assigned homework and summaries of the videos. |
| 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 intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module) |
| Psychological flexibility (MPFI) | Pre-to-post change in psychological flexibility. Higher scores on the flexibility sub scale indicating better psychological flexibility. | Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module) |
| Measure | Description | Time Frame |
|---|---|---|
| Generalized Anxiety Disorder-7 (GAD-7) | Pre-to-post change in anxious symptoms; Scores range from 0-21, with higher scoresindicating more severe anxiety | Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module) |
| Patient Health Questionnaire-9 (PHQ-9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Regina | Regina | Saskatchewan | S4S 0A2 | Canada |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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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.
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Pre-to-post change in depressive symptoms; Scores range from 0-27, with higherscores indicating more severe depressive symptoms |
| Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module) |
| D000091662 | Genital Diseases |
| D007246 | Infertility |