Clinical trial NCT03519607: The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility
Official title: The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Reduction
Keywords: Infertility
Distress
Coping
Men
Lead sponsor: Fertility Centers of Illinois
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Comparison of distress scores between the intervention group and the control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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:

1. Study participants will be asked to complete an on-line questionnaire.
2. 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.
3. 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.

Eligibility criteria: 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:

1. Does not have daily access to a smart phone
2. Does not read or understand English

Primary outcomes:
measure: Anxiety and Depression in Men Experiencing Infertility
timeFrame: 6 months post study completion
Secondary outcomes:
measure: Stress Levels in Men Experiencing Infertility
timeFrame: 6 months post study completion
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Fertility Centers of Illinois
state: Illinois
Study officials:
affiliation: Fertility Centers of Illinois
name: Meike Uhler, MD
role: PRINCIPAL_INVESTIGATOR
References: