The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice

Depression Clinical Trial

Official title:

The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02953444
• Other study ID #: Pro00072981
• Status: Terminated
• Phase: N/A
• Start date: November 2016
• Est. completion date: September 9, 2018

Study information

• Verified date: December 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: September 9, 2018
• Est. primary completion date: September 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Mental Disorders
• Psychotic Disorders

Intervention

Other:
• Thirty-Second Mindfulness Practice

• Three-Minute Mindfulness Practice

Locations

Country	Name	City	State
United States	Duke Office of Clinical Research REDCap Online Data Collection Software	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

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. — View 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. — View 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. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in trait mindfulness as measured by the Five Facet Mindfulness Questionnaire (Baer et al. 2006)		Baseline, 2 weeks and 4 weeks
Primary	Change in perceived stress as measured by the Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983)		Baseline, 2 weeks and 4 weeks
Primary	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
Primary	Change in mood as measured by the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988)		Baseline, 2 weeks and 4 weeks
Primary	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
Primary	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	Group difference in intervention's acceptability as measured by qualitative questions		1 week into intervention
Secondary	Group difference in adherence as measured by frequency of daily brief mindfulness practice use		Daily for two weeks of intervention
Secondary	Group difference in continued brief mindfulness practice use as measured by follow-up question		Follow up (two weeks after intervention)
Secondary	Change in daily mood measured on a visual analogue scale		Daily for two weeks of intervention
Secondary	Change in daily stress level measured on a visual analogue scale		Daily for two weeks of intervention
Secondary	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
Secondary	Change in perspective taking as measured by questions adapted from Hawk, Fischer and Van Kleef, (2011)		Baseline, 2 weeks and 4 weeks