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

NCT ID: NCT03519607

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Stress Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Comparison of distress scores between the intervention group and the control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Participant assignment will be masked for data analysis

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

FertiStrong App

Intervention Type BEHAVIORAL

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).

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Other Intervention Names

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FertiStrong

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fertility Centers of Illinois

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meike Uhler, MD

Role: PRINCIPAL_INVESTIGATOR

Fertility Centers of Illinois

Locations

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Fertility Centers of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lauren Jasulaitis, CRC

Role: CONTACT

(847) 916-6553

Sue Jasulaitis, RN MSN

Role: CONTACT

(847) 916-6297

Facility Contacts

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Lauren Jasulaitis, CRC

Role: primary

847-916-6553

Sue Jasulaitis, RN MSN

Role: backup

(847) 916-6297

Other Identifiers

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20180901

Identifier Type: -

Identifier Source: org_study_id

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