The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice

NCT ID: NCT02953444

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-09-09

Brief Summary

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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

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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.

Conditions

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Depression Anxiety Mental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wait List Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Thirty-Second Mindfulness Practice

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Three-Minute Mindfulness Practice

Intervention Type OTHER

Interventions

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Thirty-Second Mindfulness Practice

Intervention Type OTHER

Three-Minute Mindfulness Practice

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moria Smoski, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Office of Clinical Research REDCap Online Data Collection Software

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16443717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6668417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16717171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3397865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18752852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1593914 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23796855 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 21668103 (View on PubMed)

Other Identifiers

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Pro00072981

Identifier Type: -

Identifier Source: org_study_id