DepressionNCT02953444
The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice
A study testing Thirty-Second Mindfulness Practice and Three-Minute Mindfulness Practice in people with Depression and Anxiety, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Mental Disorders
- What is being tested?
- Thirty-Second Mindfulness Practice and Three-Minute Mindfulness Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 9 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not speak and read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Office of Clinical Research REDCap Online Data Collection Software
Durham, North Carolina
About this study
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.
Read the 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.
- Conditions
- Depression, Anxiety, Mental Disorders
- Being tested
- Thirty-Second Mindfulness Practice, Three-Minute Mindfulness Practice
- Medical subject headings
- Depression, Anxiety Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thirty-Second Mindfulness PracticeOther
Three-Minute Mindfulness PracticeOther
| Study group | Role | What they receive |
|---|---|---|
| Wait List Control | No intervention | Participants receive daily email surveys for two weeks before being given access to the brief-mindfulness-practice training materials. |
| Thirty-Second Mindfulness Practice | Experimental | 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. Receives: Other: Thirty-Second Mindfulness Practice |
| Three-Minute Mindfulness Practice | Active comparator | 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. Receives: Other: Three-Minute Mindfulness Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trait mindfulness as measured by the Five Facet Mindfulness Questionnaire (Baer et al. 2006)
Measured: Baseline, 2 weeks and 4 weeks
Change in perceived stress as measured by the Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983)
Measured: 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)
Measured: Baseline, 2 weeks and 4 weeks
Change in mood as measured by the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988)
Measured: 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)
Measured: 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)
Measured: Baseline, 2 weeks and 4 weeks
Secondary outcomes (7)
Group difference in intervention's acceptability as measured by qualitative questions
Measured: 1 week into intervention
Group difference in adherence as measured by frequency of daily brief mindfulness practice use
Measured: Daily for two weeks of intervention
Group difference in continued brief mindfulness practice use as measured by follow-up question
Measured: Follow up (two weeks after intervention)
Change in daily mood measured on a visual analogue scale
Measured: Daily for two weeks of intervention
Change in daily stress level measured on a visual analogue scale
Measured: 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)
Measured: Baseline, 2 weeks and 4 weeks
Change in perspective taking as measured by questions adapted from Hawk, Fischer and Van Kleef, (2011)
Measured: Baseline, 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion9 Sep 2018
- Study completion9 Sep 2018
Why it stopped: Insufficient personnel to complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moria Smoski, Ph.D, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953444
- Sponsor's protocol ID
- Pro00072981
- Status last verified
- Dec 2018
- First submitted
- 1 Nov 2016
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 16443717Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Spitzer 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.
PubMed 16717171Watson 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.
PubMed 3397865Kroenke 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.
PubMed 18752852Ware 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.
PubMed 1593914Khoury 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.
PubMed 23796855Davis, 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.
PubMed 21668103
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice
- ClinicalTrials.gov ID
- NCT02953444
- Acronym / sponsor ID
- Pro00072981
- Conditions
- Depression, Anxiety, Mental Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient personnel to complete the study.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 9 Sep 2018 (actual)
- Study completion
- 9 Sep 2018 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wait List Control | No intervention | –Participants receive daily email surveys for two weeks before being given access to the brief-mindfulness-practice training materials. |
| Thirty-Second Mindfulness Practice | Experimental | Other: Thirty-Second Mindfulness PracticeParticipants 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. |
| Three-Minute Mindfulness Practice | Active comparator | Other: Three-Minute Mindfulness PracticeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Does not speak and read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thirty-Second Mindfulness Practice | Other | Thirty-Second Mindfulness Practice |
| Three-Minute Mindfulness Practice | Other | Three-Minute Mindfulness Practice |
Primary outcome
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 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 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
7 secondary outcomes
Group difference in intervention's acceptability as measured by qualitative questions
Time frame: 1 week into intervention
Group difference in adherence as measured by frequency of daily brief mindfulness practice use
Time frame: Daily for two weeks of intervention
Group difference in continued brief mindfulness practice use as measured by follow-up question
Time frame: Follow up (two weeks after intervention)
Change in daily mood measured on a visual analogue scale
Time frame: Daily for two weeks of intervention
Change in daily stress level measured on a visual analogue scale
Time frame: 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)
Time frame: Baseline, 2 weeks and 4 weeks
Change in perspective taking as measured by questions adapted from Hawk, Fischer and Van Kleef, (2011)
Time frame: Baseline, 2 weeks and 4 weeks
Results and safety
The study was stopped early (reason given: Insufficient personnel to complete the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Background: PubMed 16443717Baer 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 3397865Watson 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.
- Background: PubMed 18752852Kroenke 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.
- Background: PubMed 1593914Ware 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.
- Background: PubMed 23796855Khoury 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.
- BackgroundDavis, M.H. (1980). A multidimensional approach to individual differences in empathy. Catalogue of Selected Documents in Psychology, 10, MS. 2124, p. 85.
- Background: PubMed 21668103Hawk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moria Smoski, Ph.D principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thirty-Second Mindfulness Practice and Three-Minute Mindfulness Practice in people with Depression and Anxiety, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient personnel to complete the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in trait mindfulness as measured by the Five Facet Mindfulness Questionnaire (Baer et al. 2006) (time frame: Baseline, 2 weeks and 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953444, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.