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

Stress Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03519607
• Other study ID #: 20180901
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2018
• Source: Fertility Centers of Illinois
• Contact: Lauren Jasulaitis, CRC
• Phone: (847) 916-6553
• Email: Lauren.Jasulaitis[@]Integramed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Stress Reduction

Intervention

Behavioral:
• FertiStrong App
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).

Locations

Country	Name	City	State
United States	Fertility Centers of Illinois	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Fertility Centers of Illinois

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety and Depression in Men Experiencing Infertility	Evaluation of pre and post Hospital Anxiety and Depression Scores	6 months post study completion
Secondary	Stress Levels in Men Experiencing Infertility	Fertility related distress will be measured using the Fertility Problem inventory (FPI)	6 months post study completion