- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03936114
Stress Management and Resiliency Training (SMART) for Family Medicine Residents at Eglin AFB
August 16, 2021 updated by: Laura Rhaney
This research seeks to identify if the practice of the SMART program mindfulness decreases stress and increase resilience in family medicine residents.
Study Overview
Detailed Description
This research seeks to identify if the practice of the SMART program mindfulness decreases stress and increase resilience in family medicine residents.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Eglin Air Force Base, Florida, United States, 32542
- 96th Medical Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
**Patients must be able to get care at Eglin Air Force Base (a military installation) in order to participate in this study**
Inclusion Criteria:
- Male and female active duty military family medicine residents
- Age 18 or older
- Amenable to participation in training and filling out questionnaires
Exclusion Criteria:
- Unwilling to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SMART
|
SMART program mindfulness training program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in "Mindful Attention Awareness Scale"
Time Frame: baseline, 12 weeks, 12 months
|
Dispositional mindfulness, i.e. open or receptive awareness of and attention to what is taking place in the present.
To score the scale, compute a mean of the 15 questions.
Higher scores reflect higher levels of dispositional mindfulness.
|
baseline, 12 weeks, 12 months
|
Change in "Perceived Stress Scale"
Time Frame: baseline, 12 weeks, 12 months
|
The Perceived Stress Scale (PSS) is a measure of the degree to which situations in one's life are appraised as stressful.
Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives.
The scale also includes a number of direct queries about current levels of experienced stress.
The PSS was designed for use in community samples with at least a junior high school education.
The items are easy to understand, and the response alternatives are simple to grasp.
Moreover, the questions are of a general nature and hence are relatively free of content specific to any subpopulation group.
The questions in the PSS ask about feelings and thoughts during the last month.
In each case, respondents are asked how often they felt a certain way.
High scores indicate higher perceived stress.
|
baseline, 12 weeks, 12 months
|
Change in "Connor-Davidson Resilience Scale 10" (CD-RISC-10)
Time Frame: baseline, 12 weeks, 12 months
|
Measure of stress coping ability.
10 questions with the option of 0 through 4, where 0 is not true at all and 4 is true nearly all the time.
Scores are added up to obtain CD-RISC score.
|
baseline, 12 weeks, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ludwig DS, Kabat-Zinn J. Mindfulness in medicine. JAMA. 2008 Sep 17;300(11):1350-2. doi: 10.1001/jama.300.11.1350. No abstract available.
- Holzel BK, Carmody J, Vangel M, Congleton C, Yerramsetti SM, Gard T, Lazar SW. Mindfulness practice leads to increases in regional brain gray matter density. Psychiatry Res. 2011 Jan 30;191(1):36-43. doi: 10.1016/j.pscychresns.2010.08.006. Epub 2010 Nov 10.
- Kerr CE, Sacchet MD, Lazar SW, Moore CI, Jones SR. Mindfulness starts with the body: somatosensory attention and top-down modulation of cortical alpha rhythms in mindfulness meditation. Front Hum Neurosci. 2013 Feb 13;7:12. doi: 10.3389/fnhum.2013.00012. eCollection 2013.
- Sibinga EM, Wu AW. Clinician mindfulness and patient safety. JAMA. 2010 Dec 8;304(22):2532-3. doi: 10.1001/jama.2010.1817. No abstract available.
- Sood, Amit. Train Your Brain....Engage Your Heart....Transform Your Life: A Course in Attention & Interpretation Therapy (AIT). Morning Dew Publications, LLC; 2009, 2010
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2019
Primary Completion (Actual)
October 27, 2020
Study Completion (Actual)
October 27, 2020
Study Registration Dates
First Submitted
April 30, 2019
First Submitted That Met QC Criteria
April 30, 2019
First Posted (Actual)
May 3, 2019
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 16, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- FWH20190021H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We do not plan on sharing data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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