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Meditation for Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Headspace app
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Contemplative, Applications, Well-being

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Emory Healthcare patient

Exclusion Criteria:

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

Sites / Locations

  • Emory University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Headspace app

Waitlist control group

Arm Description

Participants randomized to use the mindfulness app for 6 weeks.

This 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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 2, 2018
Last Updated
April 9, 2020
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03495726
Brief Title
Meditation for Pain
Official Title
Mindfulness for Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
March 3, 2020 (Actual)
Study Completion Date
March 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Contemplative, Applications, Well-being

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Headspace app
Arm Type
Experimental
Arm Description
Participants randomized to use the mindfulness app for 6 weeks.
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
This 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.
Intervention Type
Behavioral
Intervention Name(s)
Headspace app
Other Intervention Name(s)
Contemplative Applications for Well-being
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain Catastrophizing Scale Score
Description
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.
Time Frame
Baseline, Week 3, Week 6, Week 14
Title
Change in Brief Pain Inventory
Description
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.
Time Frame
Baseline, Week 3, Week 6, Week 14
Title
Change in Current Opioid Misuse Measure (COMM) Score
Description
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.
Time Frame
Baseline, Week 3, Week 6, Week 14
Secondary Outcome Measure Information:
Title
Change in Physical Functioning Subscale (PF-10) Score
Description
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.
Time Frame
Baseline, Week 3, Week 6, Week 14
Title
Change in Basel Assessment of Adherence Immunosuppression Scale Score
Description
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.
Time Frame
Baseline, Week 3, Week 6, Week 14
Title
Change in Depression Anxiety and Stress Scale (DASS) Score
Description
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.
Time Frame
Baseline, Week 3, Week 6, Week 14
Title
Change in Brief Coping with Problems Experienced (COPE) Inventory
Description
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.
Time Frame
Baseline, Week 3, Week 6, Week 14
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Social Functioning - Short Form Score
Description
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.
Time Frame
Baseline, Week 3, Week 6, Week 14
Title
Change in PROMIS Loneliness - Fixed Form Score
Description
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.
Time Frame
Baseline, Week 3, Week 6, Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Emory Healthcare patient Exclusion Criteria: Non-english speaking patients Children, prisoners or other vulnerable populations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Mascaro, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Meditation for Pain

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