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Chronic PainNCT03495726

Meditation for Pain

A study testing Headspace app in people with Chronic Pain, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The general scope of the study involves meditation and its effects on pain management, narcotic use, and emotional well-being. Half of the participants will receive access to a meditation app, which they will be asked to use for at least 10 minutes every day for 6 weeks, while the other participants will be in the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Headspace app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteUnited States
Study dates
5 Jun 2018to 3 Mar 2020
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

  • Emory Healthcare patient

Who cannot join

  • Non-english speaking patients
  • Children, prisoners or other vulnerable populations

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Hospital

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Mindfulness for Pain

The general scope of the study involves meditation and its effects on pain management, narcotic use, and emotional well-being. Half of the participants will receive access to a meditation app, which they will be asked to use for at least 10 minutes every day for 6 weeks, while the other participants will be in the waitlist group and will receive a subscription to the meditation app after the 6 week study period ends. All participants will be asked to complete a set of questionnaires

Read the detailed description

Chronic pain affects an estimated 11.2% of the US population, costs the United States approximately $635 billion per year in medical expenses and lost productivity, and fuels the current epidemic of opioid addiction. Understanding alternate approaches to chronic pain management is an imperative given new guidelines for the treatment of pain, and preliminary studies indicate that meditation programs may reduce the suffering and distress that accompanies chronic pain. However, much of the research on meditation for pain has examined the effects of scheduled group interventions, delivered in-person by instructors over the course of several weeks. Far less research has looked at the delivery method that is most common and arguably most sustainable for busy adults, namely, smart phone delivered Contemplative Applications (Apps) for Well-being (CAWs). The proposed study will examine the use and impact of a meditation apps in the context of pain. Participants will be randomized to either app or a wait-list group, and will be assessed in terms of self-reported pain, distress, narcotic use. To assess efficacy, the researchers will examine the longitudinal changes in all measures in the mindfulness app group, compared to wait-list control groups.

Conditions
Chronic Pain
Being tested
Headspace app
Keywords
Contemplative, Applications, Well-being
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Headspace appBehavioural

    Also called Contemplative Applications for Well-being

    Headspace is a Contemplative Application (App) for Well-being (CAW). Participants will be provided initial instructions for downloading and using the Headspace app. The Headspace app includes guided meditations, articles and videos. Participants will be asked to engage in meditation practice for an average of 10 minutes a day during the 6-week training period.

Study groups in NCT03495726
Study groupRoleWhat they receive
Headspace appExperimentalParticipants randomized to use the mindfulness app for 6 weeks.
Receives: Behavioral: Headspace app
Waitlist control groupNo interventionThis group will receive treatment as usual for 6 weeks. After the completing the 6-week surveys, the waitlist group will receive a subscription to the Headspace app.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pain Catastrophizing Scale Score

    The Pain Catastrophizing Scale is a 13-item inventory that measures 3 elements of the perception of the intensity of pain (rumination, magnification, feeling helpless). Participants indicate the degree to which they agree with statements related their pain by selecting 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree, 4 = all the time. There are three subscale scores assessing rumination, magnification and helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel.

    helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel.

    Measured: Baseline, Week 3, Week 6, Week 14

  2. Change in Brief Pain Inventory

    The Brief Pain Inventory is a 9-item inventory that measures both pain severity and pain interference in daily functioning with 2 scales. Questions are answered on an 11-point Likert scale from 0 to 10 and scales are scored by obtaining the mean for two separate scales: pain severity and pain interference.

    Measured: Baseline, Week 3, Week 6, Week 14

  3. Change in Current Opioid Misuse Measure (COMM) Score

    The COMM is a 17-item questionnaire assessing the aberrant medication-related behaviors of patients with chronic pain. Participants indicate how often they have experienced specific aberrant medication-related behaviors in the past 30 days on a scale from 0 (never) to 4 (very often). Total scores range from 0 to 68 with higher scores indicating more problematic behaviors.

    Measured: Baseline, Week 3, Week 6, Week 14

Secondary outcomes (6)

  1. Change in Physical Functioning Subscale (PF-10) Score

    The PF-10 is a 10-item questionnaire assessing daily functioning. Participants respond to statements about how limited they are when performing daily living activities on a scale from 1 (cannot do) to 5 (not limited). Total scores range from 10 to 50 with higher scores indicating greater physical function.

    Measured: Baseline, Week 3, Week 6, Week 14

  2. Change in Basel Assessment of Adherence Immunosuppression Scale Score

    The Basel Assessment of Adherence Immunosuppression Scale is a 4-item questionnaire designed to assess adherence to medication regimen. Participants are asked about how well they have taken their medication during the past 4 weeks on a scale from 0 (never) to 5 (every day). Total scores range from 0 to 24 and higher score indicate greater problems with medication adherence.

    Measured: Baseline, Week 3, Week 6, Week 14

  3. Change in Depression Anxiety and Stress Scale (DASS) Score

    The Depression Anxiety and Stress Scale (DASS) is a 21-item survey asking about feelings of depression and anxiety that the respondent has experienced in the past week (for example, "I found myself getting upset at quite trivial things"). Respondents indicate the degree to which they agree with each statement on a scale of 0 to 3 where 0 = does not apply to me at all and 3 = applied to me very much, or most of the time. The depression subscale includes 14 items. A score of 0-9 indicates no depression, 10-13 indicates moderate depression, 14-20 is moderate depression, 21-27 is severe depression and scores of 28 and above indicate extremely severe depression.

    Measured: Baseline, Week 3, Week 6, Week 14

  4. Change in Brief Coping with Problems Experienced (COPE) Inventory

    The Brief COPE Inventory is a 28-item measurement assessing different types of coping mechanisms. Participants respond to statements expressing different ways to cope with life stress on a scale from 1 (I haven't been doing this at all) to 5 (I've been doing this a lot). This inventory is not designed for a summary score, rather, 14 separate scales with 2 items each can be examined and grouped into categories as desired. Total scores for each scale range from 2 to 10 with higher values indicating increased use of that coping mechanism.

    Measured: Baseline, Week 3, Week 6, Week 14

  5. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Social Functioning - Short Form Score

    The PROMIS Social Functioning - Short Form is a 5-item measure assessing the ability to participate is social roles. Participants respond to statements about how their health impacts their social interactions on a scale from 1 (always) to 5 (never). Total scores range from 5 to 25 where higher scores indicate greater functioning in social roles.

    Measured: Baseline, Week 3, Week 6, Week 14

  6. Change in PROMIS Loneliness - Fixed Form Score

    The PROMIS Loneliness - Fixed Form is 5-item measure assessing loneliness. Participants report how often they have felt different aspects of loneliness on a scale from 1 (never) to 5 (always). Total scores range from 5 to 25 and higher scores indicate greater feelings of loneliness.

    Measured: Baseline, Week 3, Week 6, Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2018
  2. Study start5 Jun 2018
  3. Primary completion3 Mar 2020
  4. Study completion3 Mar 2020

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03495726
Sponsor's protocol ID
IRB00095434
Status last verified
Mar 2020
First submitted
2 Apr 2018
Last updated
13 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Headspace app in people with Chronic Pain, run by Emory 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 13 Apr 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Pain Catastrophizing Scale Score (time frame: Baseline, Week 3, Week 6, Week 14). The study lists 3 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 NCT03495726.

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 13 Apr 2020; AzTrials last refreshed its copy on 28 Oct 2026.

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