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Clinical Trials/NCT02953444
NCT02953444
Terminated
Not Applicable

The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice

Duke University1 site in 1 country42 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Duke University
Enrollment
42
Locations
1
Primary Endpoint
Change in perceived stress as measured by the Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983)
Status
Terminated
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
September 9, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in perceived stress as measured by the Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983)

Time Frame: 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)

Time Frame: Baseline, 2 weeks and 4 weeks

Change in mood as measured by the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988)

Time Frame: 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)

Time Frame: Baseline, 2 weeks and 4 weeks

Change in trait mindfulness as measured by the Five Facet Mindfulness Questionnaire (Baer et al. 2006)

Time Frame: 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)

Time Frame: Baseline, 2 weeks and 4 weeks

Secondary Outcomes

  • 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)
  • 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)
  • Change in perspective taking as measured by questions adapted from Hawk, Fischer and Van Kleef, (2011)(Baseline, 2 weeks and 4 weeks)
  • Group difference in adherence as measured by frequency of daily brief mindfulness practice use(Daily for two weeks of intervention)
  • Group difference in intervention's acceptability as measured by qualitative questions(1 week into intervention)
  • Group difference in continued brief mindfulness practice use as measured by follow-up question(Follow up (two weeks after intervention))

Study Sites (1)

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