Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03085212 |
| Other study ID # |
2015H0395 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 21, 2017 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Ohio State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of pilot study application is to build on the investigators' previous work that
established the prospective association between stress and infertility. Specifically, the
investigators hope to collect the preliminary data necessary to make them competitive to
submit a R01 application to NIH for funding of a full-scale randomized controlled trial of an
internet-based stress management program to examine its efficacy in decreasing stress and
increasing pregnancy rates among women who have tried to get pregnant for 6-12 months without
success. The program called Stress Free Now (SFN) was developed at the Cleveland Clinic and
has been shown to be effective in lowering stress in a variety of populations. The program
introduces concepts of mindfulness and cognitive-behavioral therapy to assist individuals in
managing their stress levels. The intervention includes Internet-based interaction, daily
emails and recommended relaxation practice of at least four days per week. Using targeted
Facebook Ads and other recruitment modalities, the investigators will randomize 40 women ages
18-34 who have been trying to conceive for 6-12 months without success. The PI has been
enrolling women in a similar study using this mechanism and has found it to be an efficient
and cost-effective method of identifying potentially eligible individuals. Women will be
randomized to SFN or a wait list control condition and will be followed for up to three
months post-randomization with weekly journals as they try to conceive. The primary outcome
of this randomized controlled trial is stress level, as measured by salivary alpha-amylase,
while the secondary outcome will be pregnancy rate at the end of the three-month follow-up
period.
Description:
To allow us to address the significant data gap regarding the efficacy of interventions to
reduce stress and increase fecundity, we will conduct a randomized controlled trial of a
proven 6-week online stress management program called Stress Free Now (SFN). Women will be
randomized to SFN or a wait list control condition (i.e., participants assigned to the
control arm with be offered SFN at the end of the study, even if they are already pregnant).
Women will be followed for three months from the date of randomization as they continue to
try to conceive. Women who report pursuing fertility treatment will be censored on the day
they report initiating treatment.
Participants will be recruited primarily using targeted Facebook Ads, though other modalities
will also be used like local ads, and ResearchMatch. The PI used Facebook for recruitment for
a similar study and found it to be a very efficient method for identifying women who are
currently trying to conceive. We will preferentially target women in the Midwest for this
pilot study in order to keep shipping costs low.
For the proposed study, the Facebook Ad will direct participants to the study website where
they can obtain more information and complete a preliminary screening questionnaire using a
secure online form. The brief screening questionnaire will assess whether the potential
participant meets the above-mentioned eligibility criteria and will ask individuals to
complete the State-Trait Anxiety Inventory (STAI), Trait Form, the 10-item Center for
Epidemiologic Studies Depression Scale Revised (CESDR-10), and the four-item Perceived Stress
Scale. Women who score ≥ 34 on the STAI and/or ≥ 10 on the CESDR-10 will be contacted by
study staff and offered enrollment. These two assessments were chosen because they are the
two instruments shown in the PI's prior work to correlate with salivary alpha-amylase level,
which the biomarker that the PI has found to be associated with reduced fecundity.
Eligible women who complete the questionnaire and are found to be eligible will be informed
via email and their address will be requested so that we can mail them an informed consent
and HIPAA documents. The forms will be mailed and participants will be asked to return it to
study staff using the prepaid envelope. When the signed forms are received, participants will
be sent an email with a link to their baseline questionnaire. Once the baseline questionnaire
has been completed, women will be sent their first saliva collection kit as well as five
pregnancy tests for use during the study. If a woman reports on the baseline questionnaire
that she is currently receiving infertility treatment, she will be exited from the study. In
addition to collecting their saliva specimen (described below), women will be asked to use
one of the enclosed pregnancy tests immediately, to record the results (i.e., pregnant or not
pregnant), and to return the form with the saliva specimen. Any woman who reports that she is
pregnant at baseline will be thanked and exited from the study.
Women who remain eligible will be randomized in a 1:1 ratio to the SFN intervention or
waitlist control condition. The randomization scheme will be prepared and overseen by the
study biostatistician. Women will be informed of their randomization status via email. For
women randomized to the intervention, we will email staff at the Cleveland Clinic the woman's
study identification number, name, email address, and phone number so that she can be given
immediate access to Stress Free Now. For women randomized to the waitlist control condition,
Cleveland Clinic staff will be sent her information at the end of the study (women who are
randomized to the intervention group will receive access to Stress Free Now when they are
done participating). During the data collection phase of the project all investigators will
remain blinded to participants' randomization status except for the administrative support
staff who will manage correspondence and mail the packages.
The intervention for this study will be a multifaceted online stress reduction program
developed by the Cleveland Clinic. Each week for six weeks participants will be introduced to
a new lesson. The topics include: being, being aware, being neutral, being you, being
connected, and being joyful. The week will begin with a lesson guide recording that provides
an overview of the lesson, then participants will be guided to read the short daily reading
on the website (approximately one page) at which point they will be directed to complete the
daily 20-25 minute relaxation practice, which is a recorded meditation or guided imagery
exercise. The relaxation practices change with each week's lesson and participants will be
directed to complete the relaxation practice at least four times a week. The relaxation
practice recordings can be accessed at any time on the Stress Free Now website. Participants
will receive daily emails with an inspirational quote that includes reminders to log in to do
the day's reading and complete the daily relaxation practice. The daily readings discuss
topics like stress, the importance of living in the present, perfectionism, optimism, mood,
yoga, healthy eating, better sleep, loneliness and other related areas. Those data along with
the number of times that the participant logged in to the Stress Free Now website will be
recorded in the Cleveland Clinic's database and merged by participant ID with the rest of the
study data. Women assigned to the control group will be given access to the intervention
immediately upon completing the study (i.e., to fulfill the wait list control condition). It
should be noted that while intervention crossover is always a concern, SFN has not been
widely used to date (<50 public users last year) despite its demonstrated promise for
reducing stress.
Our primary endpoint will be salivary alpha-amylase level, consistent with our prior work in
this area. A highly experienced laboratory will quantify salivary cortisol and alpha-amylase
as biomarkers of stress. Cortisol (micrograms/dL) will be measured using a highly sensitive
enzyme immunoassay. Salivary alpha-amylase (U/mL) will be quantified using a commercially
available kinetic reaction assay. Our secondary outcome will be pregnancy rate after three
months of follow-up. Women will be asked to continue to participate in the study for the full
three months, even if they become pregnant (this will allow us to assess levels of stress
over time).
When sent their first saliva collection kit, participants will be provided detailed
collection instructions, which will ask the participant to collect her first saliva sample
the next morning within 10 minutes of awakening before eating, drinking, smoking, or brushing
her teeth. Participants will be advised to freeze the collected sample in her home freezer
for at least 12 hours prior to returning the sample to The Ohio State University using the
provided prepaid insulated shipping container containing the frozen cold pack (see saliva
collection form). In instances where women collects her sample too late (i.e., >30 minutes
after awakening) or the sample arrives damaged or otherwise unusable, women will be asked to
provide a replacement sample.
The Monday following randomization, women will be sent an email with a link to their first
weekly journal. Specifically, women will be asked to record their answers to the journal
questions in reference to days of bleeding, acts of intercourse, receipt of infertility
treatment, pregnancy test results, health behaviors, stress level, and efforts to reduce
stress. At weeks 6 and 12, women will also be asked to complete the PSS-4, the STAI-S Short
Form, and the CESDR-10. Women will be asked to complete this journal at the end of each week
(Mondays) until the end of the three-month follow-up period (12 journals total) or pregnancy,
whichever comes first. Women who are randomized to the intervention will be sent a welcome
email with their SFN username and password.
After 6 weeks of follow-up (corresponding to the end of the intervention for the group
randomized to SFN), women will be mailed a second package containing saliva collection
materials and will be asked to collect a second sample. Procedures will be identical to the
first sample collection.
Study staff will maintain close contact with study participants to limit loss to follow-up.
Participants in this randomized controlled trial will receive a $40 Amazon.com gift card for
completing the study. As described above, women will also receive five digital pregnancy
tests for use during the study; this will likely be viewed as a benefit by participants, but
will also serve to increase the validity of the measurement of our primary endpoint. Upon
exiting the study, all women will be asked to complete the study's exit form.
