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

Fertility Centers of Illinois

Status: Unknown

Conditions: Stress Reduction

Treatments: Behavioral: FertiStrong App

Study type: Interventional

Funder types: Other

Identifiers

NCT03519607

20180901

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Treatment Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: FertiStrong App

Control Group

No Intervention group

Description:

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.