The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice

This study will assess the efficacy of brief mindfulness practices on improving mental health in adults who are currently in treatment for mental health concerns. From online instructional videos, each participant will learn a thirty-second or three-minute mindfulness practice that is to be performed at least three times daily over two weeks.

Study Overview

• Status: Terminated
• Conditions: Mental Disorders; Depression; Anxiety
• Intervention / Treatment: Other: Thirty-Second Mindfulness Practice; Other: Three-Minute Mindfulness Practice

Detailed Description

Mindfulness meditation and mindfulness-based therapies have been shown to improve many aspects of psychological functioning in individuals with mental health problems.

The purpose of this study is to assess the feasibility, acceptability, and efficacy in improving mental health of brief mindfulness practices in adults currently in treatment for mental health concerns. The entire study will be administered online. From online instructional videos, each participant will learn a thirty-second or three-minute mindfulness practice that is to be performed at least three times daily over two weeks. A delayed-treatment control group will begin the intervention after a two-week waiting period.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States
      • Duke Office of Clinical Research REDCap Online Data Collection Software

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Regular internet access
• Able to listen to audio files
• Currently receiving outpatient care
• No change in type of psychotherapy during the past month
• If taking medications, a stable, unchanging prescription for the previous month
• Willingness to sign release of mental health care information
• Capacity to provide informed consent

Exclusion Criteria:

• Does not speak and read English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Wait List Control; Participants receive daily email surveys for two weeks before being given access to the brief-mindfulness-practice training materials.
Experimental: Thirty-Second Mindfulness Practice; Participants watch a ten minute mindfulness training video then are given electronic access to an audio recording of guidance for a thirty-second mindfulness meditation practice. Participants are asked to complete this practice using the audio-recorded guidance at least three times a day for two weeks. Participants are sent daily emails that include reminders to complete the practice and a link to a brief online survey.	Other: Thirty-Second Mindfulness Practice
Active Comparator: Three-Minute Mindfulness Practice; Participants watch a ten minute mindfulness training video then are given electronic access to an audio recording of guidance for a three minute mindfulness meditation practice. Participants are asked to complete this practice using the audio-recorded guidance at least three times a day for two weeks. Participants are sent daily emails that include reminders to complete the practice and a link to a brief online survey.	Other: Three-Minute Mindfulness Practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in trait mindfulness as measured by the Five Facet Mindfulness Questionnaire (Baer et al. 2006)	Baseline, 2 weeks and 4 weeks
Change in perceived stress as measured by the Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983)	Baseline, 2 weeks and 4 weeks
Change in anxiety symptoms as measured by the GAD-7, Generalized Anxiety Disorder Scale (Spitzer, Kroenke, Williams, & Löwe, 2006)	Baseline, 2 weeks and 4 weeks
Change in mood as measured by the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988)	Baseline, 2 weeks and 4 weeks
Change in quality of life as measured by the Medical Outcomes Study 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992)	Baseline, 2 weeks and 4 weeks
Change in depression symptoms as measured by the PHQ-8, Patient Health Questionnaire - depression module (Spitzer, Kroenke, & Williams, 1999)	Baseline, 2 weeks and 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Group difference in intervention's acceptability as measured by qualitative questions	1 week into intervention
Group difference in adherence as measured by frequency of daily brief mindfulness practice use	Daily for two weeks of intervention
Group difference in continued brief mindfulness practice use as measured by follow-up question	Follow up (two weeks after intervention)
Change in daily mood measured on a visual analogue scale	Daily for two weeks of intervention
Change in daily stress level measured on a visual analogue scale	Daily for two weeks of intervention
Change in empathy as measured by the Interpersonal Reactivity Index (Davis, 1980) and four questions adapted from Hawk, Fischer and Van Kleef, (2011)	Baseline, 2 weeks and 4 weeks
Change in perspective taking as measured by questions adapted from Hawk, Fischer and Van Kleef, (2011)	Baseline, 2 weeks and 4 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Moria Smoski, Ph.D, Duke University

Publications and helpful links

General Publications

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
• Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
• Khoury B, Lecomte T, Fortin G, Masse M, Therien P, Bouchard V, Chapleau MA, Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev. 2013 Aug;33(6):763-71. doi: 10.1016/j.cpr.2013.05.005. Epub 2013 Jun 7.
• Davis, M.H. (1980). A multidimensional approach to individual differences in empathy. Catalogue of Selected Documents in Psychology, 10, MS. 2124, p. 85.
• Hawk ST, Fischer AH, Van Kleef GA. Taking your place or matching your face: two paths to empathic embarrassment. Emotion. 2011 Jun;11(3):502-13. doi: 10.1037/a0022762.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): September 9, 2018
• Study Completion (Actual): September 9, 2018

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: Pro00072981

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO