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The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice

Primary Purpose

Depression, Anxiety, Mental Disorders

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thirty-Second Mindfulness Practice
Three-Minute Mindfulness Practice
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke Office of Clinical Research REDCap Online Data Collection Software

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Wait List Control

Thirty-Second Mindfulness Practice

Three-Minute Mindfulness Practice

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Group difference in intervention's acceptability as measured by qualitative questions
Group difference in adherence as measured by frequency of daily brief mindfulness practice use
Group difference in continued brief mindfulness practice use as measured by follow-up question
Change in daily mood measured on a visual analogue scale
Change in daily stress level measured on a visual analogue scale
Change in empathy as measured by the Interpersonal Reactivity Index (Davis, 1980) and four questions adapted from Hawk, Fischer and Van Kleef, (2011)
Change in perspective taking as measured by questions adapted from Hawk, Fischer and Van Kleef, (2011)

Full Information

First Posted
November 1, 2016
Last Updated
December 10, 2018
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02953444
Brief Title
The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice
Official Title
The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Insufficient personnel to complete the study.
Study Start Date
November 2016 (undefined)
Primary Completion Date
September 9, 2018 (Actual)
Study Completion Date
September 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Mental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Participants receive daily email surveys for two weeks before being given access to the brief-mindfulness-practice training materials.
Arm Title
Thirty-Second Mindfulness Practice
Arm Type
Experimental
Arm Description
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.
Arm Title
Three-Minute Mindfulness Practice
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Thirty-Second Mindfulness Practice
Intervention Type
Other
Intervention Name(s)
Three-Minute Mindfulness Practice
Primary Outcome Measure Information:
Title
Change in trait mindfulness as measured by the Five Facet Mindfulness Questionnaire (Baer et al. 2006)
Time Frame
Baseline, 2 weeks and 4 weeks
Title
Change in perceived stress as measured by the Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983)
Time Frame
Baseline, 2 weeks and 4 weeks
Title
Change in anxiety symptoms as measured by the GAD-7, Generalized Anxiety Disorder Scale (Spitzer, Kroenke, Williams, & Löwe, 2006)
Time Frame
Baseline, 2 weeks and 4 weeks
Title
Change in mood as measured by the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988)
Time Frame
Baseline, 2 weeks and 4 weeks
Title
Change in quality of life as measured by the Medical Outcomes Study 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992)
Time Frame
Baseline, 2 weeks and 4 weeks
Title
Change in depression symptoms as measured by the PHQ-8, Patient Health Questionnaire - depression module (Spitzer, Kroenke, & Williams, 1999)
Time Frame
Baseline, 2 weeks and 4 weeks
Secondary Outcome Measure Information:
Title
Group difference in intervention's acceptability as measured by qualitative questions
Time Frame
1 week into intervention
Title
Group difference in adherence as measured by frequency of daily brief mindfulness practice use
Time Frame
Daily for two weeks of intervention
Title
Group difference in continued brief mindfulness practice use as measured by follow-up question
Time Frame
Follow up (two weeks after intervention)
Title
Change in daily mood measured on a visual analogue scale
Time Frame
Daily for two weeks of intervention
Title
Change in daily stress level measured on a visual analogue scale
Time Frame
Daily for two weeks of intervention
Title
Change in empathy as measured by the Interpersonal Reactivity Index (Davis, 1980) and four questions adapted from Hawk, Fischer and Van Kleef, (2011)
Time Frame
Baseline, 2 weeks and 4 weeks
Title
Change in perspective taking as measured by questions adapted from Hawk, Fischer and Van Kleef, (2011)
Time Frame
Baseline, 2 weeks and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moria Smoski, Ph.D
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Office of Clinical Research REDCap Online Data Collection Software
City
Durham
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16443717
Citation
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.
Results Reference
background
PubMed Identifier
6668417
Citation
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.
Results Reference
background
PubMed Identifier
16717171
Citation
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.
Results Reference
background
PubMed Identifier
3397865
Citation
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.
Results Reference
background
PubMed Identifier
18752852
Citation
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.
Results Reference
background
PubMed Identifier
1593914
Citation
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.
Results Reference
background
PubMed Identifier
23796855
Citation
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.
Results Reference
background
Citation
Davis, M.H. (1980). A multidimensional approach to individual differences in empathy. Catalogue of Selected Documents in Psychology, 10, MS. 2124, p. 85.
Results Reference
background
PubMed Identifier
21668103
Citation
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.
Results Reference
background

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The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice

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