NCT03936114

Brief Summary

This research seeks to identify if the practice of the SMART program mindfulness decreases stress and increase resilience in family medicine residents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2020

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

April 30, 2019

Last Update Submit

August 16, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in "Mindful Attention Awareness Scale"

    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"

    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)

    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

Study Arms (1)

SMART

EXPERIMENTAL
Behavioral: SMART

Interventions

SMARTBEHAVIORAL

SMART program mindfulness training program

SMART

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female active duty military family medicine residents
  • Age 18 or older
  • Amenable to participation in training and filling out questionnaires

You may not qualify if:

  • Unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

96th Medical Group

Eglin Air Force Base, Florida, 32542, United States

Location

Related Publications (5)

  • 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.

    PMID: 18799450BACKGROUND
  • 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.

    PMID: 21071182BACKGROUND
  • 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.

    PMID: 23408771BACKGROUND
  • 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.

    PMID: 21139116BACKGROUND
  • Sood, Amit. Train Your Brain....Engage Your Heart....Transform Your Life: A Course in Attention & Interpretation Therapy (AIT). Morning Dew Publications, LLC; 2009, 2010

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 3, 2019

Study Start

May 15, 2019

Primary Completion

October 27, 2020

Study Completion

October 27, 2020

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

We do not plan on sharing data

Locations