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 : Unknown
Verified May 2018 by Fertility Centers of Illinois.
Recruitment status was: Recruiting
First Posted : May 9, 2018
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stress Reduction||Behavioral: FertiStrong App||Not Applicable|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
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.
- Anxiety and Depression in Men Experiencing Infertility [ Time Frame: 6 months post study completion ]Evaluation of pre and post Hospital Anxiety and Depression Scores
- 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)
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
|Contact: Lauren Jasulaitis, CRC||(847) 916-6553||Lauren.Jasulaitis@Integramed.com|
|Contact: Sue Jasulaitis, RN MSN||(847) 916-6297||Sue.Jasulaitis@integramed.com|
|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|
|Principal Investigator:||Meike Uhler, MD||Fertility Centers of Illinois|