The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice

NCT02953444 | Terminated

• 1 other identifier: Pro00072981
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anxiety; Mental Disorders

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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

Study Arms (3)

Wait List Control

NO INTERVENTION

Participants receive daily email surveys for two weeks before being given access to the brief-mindfulness-practice training materials.

Thirty-Second Mindfulness Practice

EXPERIMENTAL

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

Three-Minute Mindfulness Practice

ACTIVE COMPARATOR

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

Interventions

Thirty-Second Mindfulness Practice OTHER

Thirty-Second Mindfulness Practice

Three-Minute Mindfulness Practice OTHER

Three-Minute Mindfulness Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Does not speak and read English

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Office of Clinical Research REDCap Online Data Collection Software

Durham, North Carolina, United States

Location

Related Publications (9)

• 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.

  PMID: 16443717 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 3397865 BACKGROUND

• 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.

  PMID: 18752852 BACKGROUND

• 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.

  PMID: 1593914 BACKGROUND

• 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.

  PMID: 23796855 BACKGROUND

• Davis, M.H. (1980). A multidimensional approach to individual differences in empathy. Catalogue of Selected Documents in Psychology, 10, MS. 2124, p. 85.

  BACKGROUND

• 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.

  PMID: 21668103 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Moria Smoski, Ph.D

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 2, 2016
• Study Start: November 1, 2016
• Primary Completion: September 9, 2018
• Study Completion: September 9, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)