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The purpose of this study is to determine if the use of a new app, FertiStrong, is associated with decreased levels of anxiety and depression in men who have infertility or whose partner has infertility.
Individuals who are experiencing infertility report high levels of anxiety and depression. A recent study (1) documented that both men and women involved in the treatment of infertility expressed emotional distress. Research on the female partner of an infertile couple documents that psychological interventions, especially those with a cognitive-behavior therapy (CBT) focus, are associated with significant decreases in levels of anxiety and depression (2). Subsequent research has also shown that both members of the infertile couple definitively underutilize the psychological services offered to them. Thus, new ways to provide psychological relief to these individuals is needed. This has lead to the development of a new app, FertiStrong. This app is targeted at men- either men with infertility or men whose partner has infertility.
Study Requirements:
Men who are directly seeking care or whose partners is seeking care at any Fertility Center of Illinois location are invited to participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | Participants who are in the intervention group will receive the FertiStrong app downloading instructions as soon as they have been randomized. They will have access to this app for a period of 30 days during the intervention phase of the study. |
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| Control Group | No Intervention | Participants in the control group will not have access to the FertiStrong app for the first 30 days. After a period of 30 days, participants will be provided downloading instructions to this app. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FertiStrong App | Behavioral | The FertiStrong mobile app is similar to FertiCalm, which is designed for women with infertility. FertiCalm (www.FertiCalm.com) can be downloaded for free anywhere in the US, for both Apple and Android phones. Each app contains twelve main categories and each main category contains up to five tailored situations. For each situation, there are six options. Three of the options are the same for all situations (humor, self-nurture, relaxation) and three are unique (cognitive solutions, behavioral solutions, social solutions). |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety and Depression in Men Experiencing Infertility | Evaluation of pre and post Hospital Anxiety and Depression Scores | 6 months post study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Stress Levels in Men Experiencing Infertility | Fertility related distress will be measured using the Fertility Problem inventory (FPI) | 6 months post study completion |
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Inclusion Criteria:
Exclusion Criteria:
Males experiencing infertility, or men whose partner is experiencing infertility
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Jasulaitis, CRC | Contact | (847) 916-6553 | Lauren.Jasulaitis@Integramed.com | |
| Sue Jasulaitis, RN MSN | Contact | (847) 916-6297 | Sue.Jasulaitis@integramed.com |
| Name | Affiliation | Role |
|---|---|---|
| Meike Uhler, MD | Fertility Centers of Illinois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility Centers of Illinois | Recruiting | Chicago | Illinois | 60610 | United States |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
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Comparison of distress scores between the intervention group and the control group
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Participant assignment will be masked for data analysis
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|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |