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

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ClinicalTrials.gov Identifier: NCT03519607
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Fertility Centers of Illinois

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
Stress Reduction Behavioral: FertiStrong App Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Comparison 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 : April 30, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Infertility

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 Name: 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.



Primary Outcome Measures :
  1. Anxiety and Depression in Men Experiencing Infertility [ Time Frame: 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 [ Time Frame: 6 months post study completion ]
    Fertility related distress will be measured using the Fertility Problem inventory (FPI)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males experiencing infertility, or men whose partner is experiencing infertility
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519607


Contacts
Contact: Lauren Jasulaitis, CRC (847) 916-6553 Lauren.Jasulaitis@Integramed.com
Contact: Sue Jasulaitis, RN MSN (847) 916-6297 Sue.Jasulaitis@integramed.com

Locations
United States, Illinois
Fertility Centers of Illinois Recruiting
Chicago, Illinois, United States, 60610
Contact: Lauren Jasulaitis, CRC    847-916-6553    Lauren.Jasulaitis@Integramed.com   
Contact: Sue Jasulaitis, RN MSN    (847) 916-6297    Sue.Jasulaitis@integramed.com   
Principal Investigator: Meike Uhler, MD         
Sponsors and Collaborators
Fertility Centers of Illinois
Investigators
Principal Investigator: Meike Uhler, MD Fertility Centers of Illinois

Responsible Party: Fertility Centers of Illinois
ClinicalTrials.gov Identifier: NCT03519607     History of Changes
Other Study ID Numbers: 20180901
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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
Genital Diseases, Male
Genital Diseases, Female