The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice

Study Overview
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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.

Official Title
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The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice

Conditions
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Depression, Anxiety, Mental Disorders

Intervention / Treatment
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* Other: Thirty-Second Mindfulness Practice
* Other: Three-Minute Mindfulness Practice


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Wait List Control<br>Participants receive daily email surveys for two weeks before being given access to the brief-mindfulness-practice training materials. | |
| Experimental: Thirty-Second Mindfulness Practice<br>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. | Other: Thirty-Second Mindfulness Practice<br> <br> |
| Active Comparator: Three-Minute Mindfulness Practice<br>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. | Other: Three-Minute Mindfulness Practice<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in trait mindfulness as measured by the Five Facet Mindfulness Questionnaire (Baer et al. 2006) |  | Baseline, 2 weeks and 4 weeks | 
| Change in perceived stress as measured by the Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983) |  | 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) |  | Baseline, 2 weeks and 4 weeks | 
| Change in mood as measured by the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988) |  | 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) |  | 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) |  | Baseline, 2 weeks and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group difference in intervention's acceptability as measured by qualitative questions |  | 1 week into intervention | 
| Group difference in adherence as measured by frequency of daily brief mindfulness practice use |  | Daily for two weeks of intervention | 
| Group difference in continued brief mindfulness practice use as measured by follow-up question |  | Follow up (two weeks after intervention) | 
| 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 |