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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03519607
Enrollment
100
Registered
2018-05-09
Start date
2018-04-30
Completion date
2018-12-31
Last updated
2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Reduction

Keywords

Infertility, Distress, Coping, Men

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.

Interventions

BEHAVIORALFertiStrong 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).

Sponsors

Fertility Centers of Illinois
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Participant assignment will be masked for data analysis

Intervention model description

Comparison of distress scores between the intervention group and the control group

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Anxiety and Depression in Men Experiencing Infertility6 months post study completionEvaluation of pre and post Hospital Anxiety and Depression Scores

Secondary

MeasureTime frameDescription
Stress Levels in Men Experiencing Infertility6 months post study completionFertility related distress will be measured using the Fertility Problem inventory (FPI)

Countries

United States

Contacts

Primary ContactLauren Jasulaitis, CRC
Lauren.Jasulaitis@Integramed.com(847) 916-6553
Backup ContactSue Jasulaitis, RN MSN
Sue.Jasulaitis@integramed.com(847) 916-6297

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026