Clinical trial NCT02953444: 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
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Anxiety
Mental Disorders
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in trait mindfulness as measured by the Five Facet Mindfulness Questionnaire (Baer et al. 2006)
timeFrame: Baseline, 2 weeks and 4 weeks
measure: Change in perceived stress as measured by the Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983)
timeFrame: Baseline, 2 weeks and 4 weeks
measure: Change in anxiety symptoms as measured by the GAD-7, Generalized Anxiety Disorder Scale (Spitzer, Kroenke, Williams, & Löwe, 2006)
timeFrame: Baseline, 2 weeks and 4 weeks
measure: Change in mood as measured by the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988)
timeFrame: Baseline, 2 weeks and 4 weeks
measure: Change in quality of life as measured by the Medical Outcomes Study 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992)
timeFrame: Baseline, 2 weeks and 4 weeks
measure: Change in depression symptoms as measured by the PHQ-8, Patient Health Questionnaire - depression module (Spitzer, Kroenke, & Williams, 1999)
timeFrame: Baseline, 2 weeks and 4 weeks
Secondary outcomes:
measure: Group difference in intervention's acceptability as measured by qualitative questions
timeFrame: 1 week into intervention
measure: Group difference in adherence as measured by frequency of daily brief mindfulness practice use
timeFrame: Daily for two weeks of intervention
measure: Group difference in continued brief mindfulness practice use as measured by follow-up question
timeFrame: Follow up (two weeks after intervention)
measure: Change in daily mood measured on a visual analogue scale
timeFrame: Daily for two weeks of intervention
measure: Change in daily stress level measured on a visual analogue scale
timeFrame: Daily for two weeks of intervention
measure: Change in empathy as measured by the Interpersonal Reactivity Index (Davis, 1980) and four questions adapted from Hawk, Fischer and Van Kleef, (2011)
timeFrame: Baseline, 2 weeks and 4 weeks
measure: Change in perspective taking as measured by questions adapted from Hawk, Fischer and Van Kleef, (2011)
timeFrame: Baseline, 2 weeks and 4 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Office of Clinical Research REDCap Online Data Collection Software
state: North Carolina
Study officials:
affiliation: Duke University
name: Moria Smoski, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
citation: Davis, M.H. (1980). A multidimensional approach to individual differences in empathy. Catalogue of Selected Documents in Psychology, 10, MS. 2124, p. 85.
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.