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

Sponsor
Fertility Centers of Illinois (Other)
Overall Status
Unknown status
CT.gov ID
NCT03519607
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
12.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: FertiStrong App
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Comparison of distress scores between the intervention group and the control groupComparison of distress scores between the intervention group and the control group
Masking:
Single (Outcomes Assessor)
Masking Description:
Participant assignment will be masked for data analysis
Primary Purpose:
Supportive Care
Official Title:
The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility
Actual Study Start Date :
Apr 30, 2018
Anticipated Primary Completion Date :
Jun 30, 2018
Anticipated Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment Group

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
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).
Other Names:
  • FertiStrong

    		•
    No Intervention: Control Group

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Anxiety and Depression in Men Experiencing Infertility [6 months post study completion]

      Evaluation of pre and post Hospital Anxiety and Depression Scores

    Secondary Outcome Measures

    1. Stress Levels in Men Experiencing Infertility [6 months post study completion]

      Fertility related distress will be measured using the Fertility Problem inventory (FPI)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fertility Centers of Illinois Chicago Illinois United States 60610

    Sponsors and Collaborators

    • Fertility Centers of Illinois

    Investigators

    • Principal Investigator: Meike Uhler, MD, Fertility Centers of Illinois

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fertility Centers of Illinois
    ClinicalTrials.gov Identifier:
    NCT03519607
    Other Study ID Numbers:
    • 20180901
    First Posted:
    May 9, 2018
    Last Update Posted:
    May 9, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Fertility Centers of Illinois
    Infertility
    Distress
    Coping
    Men
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of May 9, 2018