The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Study participants will be asked to complete an on-line questionnaire. Once completed, the study participant will be randomly assigned to one of two groups. One group will be provided the mobile app to use for 30 days. The second group will be provided the app after 30 days. After the 30 day period, each group will be asked to complete a follow-up questionnaire. Each questionnaire will take approximately 15-20 minutes to compete. Men who are directly seeking care or whose partners is seeking care at any Fertility Center of Illinois location are invited to participate.

Official Title
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The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility

Conditions
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Stress Reduction

Intervention / Treatment
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* Behavioral: FertiStrong App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All men who are receiving care, or whose partner is receiving care, at Fertility Centers of Illinois during the study period. Exclusion Criteria: Does not have daily access to a smart phone Does not read or understand English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Comparison of distress scores between the intervention group and the control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group<br>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. | Behavioral: FertiStrong App<br>* 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).<br>* Other names: FertiStrong;|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Men, Infertility, Distress, Coping