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Clinical Trials/NCT03781336
NCT03781336CompletedNot Applicable

Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals and Trainees: A Randomized Clinical Trial

National Institutes of Health Clinical Center (CC)1 site in 1 country82 target enrollmentStarted: October 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
82
Locations
1
Primary Endpoint
Perceived Stress Scale (PSS)

Study Overview

Brief Summary

Stress among healthcare professionals is well documented. Untreated stress can lead to anxiety, depression, substance use, and suicide. The use of mindfulness-based programs to reduce stress and enhance wellbeing, among health care professionals, has increased with promising results. Typical mindfulness-based programs are 30 hours in length across 9 sessions. The purpose of this study is to assess the effectiveness of a shorter and more practical program that could be offered during work hours to health care professionals at the NIH Clinical Center. The program will be delivered in five weekly 1.5 hour sessions.

Detailed Description

This abridged program was designed by Dr. Rezvan Ameli who is an expert in mindfulness-based practices/therapies and was in response to the expressed needs of the NIH clinical staff and the NIH fellowship training program.

Participants completed all primary and secondary outcome measure questionnaires at week -1, 5 and 13. The life as usual control group completed all primary and secondary outcome measures at week -1, and 5.

The program is described below:

The program consisted of 5 sessions. A class binder was prepared for the participants and included information about mindfulness and its practice, practices covered in each session, Practice Plan work sheets to design home practices, pertinent reference list, guide to online services, programs and apps, selected poetry, and information regarding recorded instructions for body scan and mindful breathing by the instructor which was made available on the institution's website and could be downloaded by the participants. Each session was 1.5 hours in length and was offered on Fridays from 3-4:30 pm. Classes were instructed by Rezvan Ameli, Ph.D., clinical psychologist, an experienced mindfulness practitioner since 2003 and teacher since 2008. In addition to her background as a licensed clinical psychologist, mindfulness practitioner, teacher and writer (Ameli 2013), RA is a certified yoga teacher and is registered with the Yoga Alliance (RYT-200).

Common Elements of the Sessions

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Any National Institutes of Health (NIH) employee, contractor, or trainee willing and able to participate in a 5-week mindfulness-based self-care course during the work day.
  • •English speaking

Exclusion Criteria

  • •Persons with medical and psychiatric conditions were advised to consult with their health care practitioners prior to enrollment.

Arms & Interventions

Mindfulness-based self-care

Experimental

Mindfulness-based self-care (5 weeks)

Intervention: Mindfulness-based self care (Behavioral)

Life as usual control

No Intervention

Life as usual control (5 weeks)

Outcomes

Primary Outcomes

Perceived Stress Scale (PSS)

Time Frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)

The Perceived Stress Scale (PSS) is used to assess self-reported perceived stress. It is a 10-item scale, with a total range from 0 (no symptoms) to 40 (highest severity).

Secondary Outcomes

  • Mindful Attention Awareness Scale (MAAS) - Trait Version(Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))
  • Visual Analog Scale-Anxiety (VAS-A)(Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))
  • Maslach Burnout Inventory (MBI)(Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))
  • Mindful Attention Awareness Scale (MAAS) - State Version(Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))
  • Positive Affect Scores (PANAS)(Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))
  • Negative Affect Scores (PANAS)(Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))
  • Mindful Self Care Scale-General (MSCS-G)(Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))

Investigators

Sponsor Class
Nih
Responsible Party
Principal Investigator
Principal Investigator

Rezvan Ameli

Principal Investigator

National Institutes of Health Clinical Center (CC)

Study Sites (1)

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