Stress ReductionNCT03519607
The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility
A study testing FertiStrong App in people with Stress Reduction, run by Fertility Centers of Illinois at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Reduction
- What is being tested?
- FertiStrong App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All men who are receiving care, or whose partner is receiving care, at Fertility Centers of Illinois during the study period.
Who cannot join
- Does not have daily access to a smart phone
- Does not read or understand English
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fertility Centers of Illinois
Chicago, Illinois, 60610
Lauren Jasulaitis, CRC, 847-916-6553, Lauren.Jasulaitis@Integramed.com
Sue Jasulaitis, RN MSN, (847) 916-6297, Sue.Jasulaitis@integramed.com
About this study
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.
Read the 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:
- 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.
- Conditions
- Stress Reduction
- Being tested
- FertiStrong App
- Keywords
- Infertility, Distress, Coping, Men
- Medical subject headings
- Infertility, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FertiStrong AppBehavioural
Also called FertiStrong
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | 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. Receives: Behavioral: FertiStrong App |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and Depression in Men Experiencing Infertility
Evaluation of pre and post Hospital Anxiety and Depression Scores
Measured: 6 months post study completion
Secondary outcomes (1)
Stress Levels in Men Experiencing Infertility
Fertility related distress will be measured using the Fertility Problem inventory (FPI)
Measured: 6 months post study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start30 Apr 2018
- Primary completion30 Jun 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Comparison of distress scores between the intervention group and the control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fertility Centers of Illinois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meike Uhler, MD, Principal investigator, Fertility Centers of Illinois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519607
- Sponsor's protocol ID
- 20180901
- Status last verified
- May 2018
- First submitted
- 6 Apr 2018
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility
- ClinicalTrials.gov ID
- NCT03519607
- Acronym / sponsor ID
- 20180901
- Conditions
- Stress Reduction
- Keywords
- Infertility, Distress, Coping, Men
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fertility Centers of IllinoisUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison of distress scores between the intervention group and the control group
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Behavioral: FertiStrong AppParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All men who are receiving care, or whose partner is receiving care, at Fertility Centers of Illinois during the study period.
Key exclusion criteria (2 listed)
- Does not have daily access to a smart phone
- Does not read or understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FertiStrong AppAlso: FertiStrongThe 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). | Behavioural | Treatment Group |
Primary outcome
Anxiety and Depression in Men Experiencing Infertility
Time frame: 6 months post study completion
Evaluation of pre and post Hospital Anxiety and Depression Scores
1 secondary outcome
Stress Levels in Men Experiencing Infertility
Time frame: 6 months post study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meike Uhler, MD principal investigator
Fertility Centers of Illinois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FertiStrong App in people with Stress Reduction, run by Fertility Centers of Illinois at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lauren Jasulaitis, CRC ((847) 916-6553, Lauren.Jasulaitis@Integramed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and Depression in Men Experiencing Infertility (time frame: 6 months post study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.