Please make sure to review the grading criteria posted under TITANium for all
discussion boards and assignments.
When designing the trial, please make sure to answer all questions in the post.
When answering the questions, please make sure to support your opinions and/or views
by concrete examples from the textbook, readings, and/or a valid website.
When discussing the RCT, please make sure that you actually designed a randomized
clinical trial. Sometimes, a cross-sectional study or a cohort study is described rather
than an RCT. An RCT randomizes individuals into the treatment and control group, and
then has some type of treatment for the treatment/intervention group and either a
placebo or education information on the treatment/intervention.
One of the biggest issue to consider when designing an RCT is related to ethics,
specifically, is the treatment ethical, and will an internal review board approve your trial.
For question 2), please provide detailed information on the exposure. For example how
long will the groups be exposed and how will compliance be monitored.
For question 3), please provide background information on the disease of interest and/or
outcomes. This could be included in your literature review.
For question 5), please make sure that your incentive is feasible.
Other General Points:
The DB must be at least 500 words.
At least two citations must be used. One from the text book and the other from a
Please read and re-read for grammar and punctuation.
Randomized clinical trials are an integral part of epidemiology and medicine. Randomized
clinical trials provide excellent methodology for studying the effects of a treatment,
intervention/exposure on disease/outcome status. After reviewing the chapters in Gordis and
the lectures online related to randomized clinical trials, briefly design a randomized clinical trial
of interest. Please provide the following:
1. What is the overall question/hypothesis you want to answer by doing this trial? Provide
background information (a short literature review) on the topic.
2. The exposure and treatment groups (instead of just using a medication, think outside the
3. The outcome/disease of interest.
4. What results are you expecting from the study?
5. How would you get people to participate in this trial? Incentives?
In order to receive credit, you must post to this board and reply to at least one other thread. In
your response post to another student, discuss some of the limitations related to the study
design and/or exposure/treatment discussed.
What is the overall question/hypothesis you want to answer by doing this trial?
The overall question this trial will answer will be whether 20mins of guided meditation before bed each
night can increase sleep duration and quality in adults with a history of chronic insomnia, and if there is
an over all improvement in wellbeing. According to Healthy People 20/20 (2016), 31.4% of adults report
having less than the required 7-8hrs of sleep per night, and 25% of adults reporting having 15 or more
days per month with insufficient sleep. Sleep, like nutrition and physical activity, is a major health
determinant of over all wellbeing.
The exposure and treatment groups
This study will utilize a randomized trial to evaluate whether 20mins of guided meditation before bed will
increase sleep duration and quality of sleep as well as over all wellbeing. Randomization will be used “to
prevent any potential biases on the part of the investigators from influencing the assignment of
participants to different treatment groups” (Gordis, 2013, p.144). The trial will require 500 patients.
General practitioners as well as doctors specializing in sleep disorders in Orange County, California will
be asked to submit possible patients who would benefit from the trial. The patients would be contacted via
email or phone to see if they fit the requirements. Those who have had < 7-8hrs of sleep per night for > 15
days per month over a 3 month period due to chronic insomnia will be asked to participate. Each patient
will be assigned a different number between 1 and 500 randomly when they enroll in the trial. The
patients with even numbers (250 total) will be the treated group who will participate in 20mins of guided
meditation before bed every night. The patients with odd numbers (250 total) will be the control. At the
beginning of the study all 500 patients (control and treated) will have a sleep evaluation performed at a
sleep center to evaluate sleep patterns as well as a physical to assess over all health. The physical will
include a blood panel to test cholesterol, blood glucose, and endocrine as well as weight and blood
pressure will be measured. All 500 patients will be educated on basic sleep hygiene. The patients will also
be required to log into a patient portal where they will complete a self-assessment that evaluates on a
scale how they rate their energy; performance at work/school; how often they exercise; how well they eat;
overall happiness. Every day all 500 patients will log in to the patient portal and log their number of hours
slept. They will also log any medication taken to assist with sleep, and/or any other treatment or technique
used to assist with sleep. The 250 even number patients (treated group) will download an app on their
phone or on their computer that they log into every night. Once logged in they will be guided through a
20min meditation. They must log in and meditate at least 30mins before bed but no earlier than 1hr before
bed every night. Every 30 days all 500 patients will do a new self-assessment on the patient portal, and
every 2-months a follow up doctor’s appointment to assess over all health including blood panels, blood
pressure, and weight. The trial will last 6-months. At the end of the 6-month period all participating
patients will have a final sleep evaluation performed at a sleep center.
The outcome/disease of interest
The disease of interest is chronic insomnia which is a long term pattern of not being able to fall asleep or
stay asleep for 3 or more nights per week for more than a 3 month period (National Sleep Foundation,
2014). 70 million Americans suffer from chronic sleep disorders leading to sleep deprivation. “Sleep
deprivation is associated with injuries, chronic diseases, mental illnesses, poor quality of life and well-
being, increased health care costs, and lost work productivity. Sleep problems are critically under-
addressed contributors to some chronic conditions, including obesity and depression” (Center of Disease
Control and Prevention, 2014). Education in sleep hygiene has shown to help with insomnia which
teachers’ patients the importance of a set bedtime, a quiet dark room, avoiding stimulants, and exercise to
assist a good nights sleep. Guided mediation has been used as a technique to assist with chronic insomnia
especially when anxiety of not being able to sleep further impacts the insomnia. By giving the treated
group the tools to implement guided meditation into their sleep hygiene regiment they will be training
their brain to relax and increase sleep quantity and quality. The outcome of the trial will see whether the
guided meditation does in fact help with chronic insomnia and how the overall wellbeing of the patients is
What results are you expecting from the study?
We are expecting to see an increase in sleep quantity and quality of sleep in the treated group with overall
improvement in wellbeing. The trial will answer the question of whether 20mins of guided meditation
before bed will improve sleep quantity and quality as well as overall wellbeing.
How would you get people to participate in this trial? Incentives?
Potential patients will be contacted via email or phone that have already been approached by their doctor
and sighted as a potential candidate. All candidates that agree to be questioned for eligibility will be given
a $5 amazon gift card for their time. The 500 who are chosen and agree to participate in the trial will be
given $50 for every month they stay in the trial. They will also have monthly health evaluations including
basic blood work to test for cholesterol, blood glucose, and a basic endocrine panel. They will also have
two sleep pattern evaluations, one at the beginning of the trial and one after the 6-month period.
Center for Disease Control and Prevention. (2014). Sleep and sleep disorders. Retrieved
Gordis, L. (2013). Epidemiology. Philadelphia: Elsevier Saunders.
Healthy People 20/20. (2016). Sleep health. Retrieved from https://www.healthypeople.gov/2020/topics-
National Sleep Foundation. (2014). Insomnia. Retrieved from https://sleepfoundation.org/insomnia/home