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Mindfully Attending to Pain Sensations

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Mindfulness
Low Mindfulness
Active Control
Sponsored by
Harvard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Pain focused on measuring pain, mindfulness, awareness, attention to variability, quality of life, wellbeing

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18+
  • Suffer from chronic pain (at least six months)
  • Evaluate their usual level of pain in the last week as 4 and above (on a numeric rating scale from 0-10 with 0 indicating "No Pain" and 10 indicating "Worst pain imaginable)
  • Fluent in English
  • Owns a smartphone

Exclusion Criteria:

  • Individuals under the age of 18;
  • Individuals who are not patients of our collaborating pain clinics or online chronic pain support groups and/or do not endorse their pain as chronic.
  • Individuals who are pregnant
  • Individuals with diagnosed cognitive impairment
  • Individuals who would not be able to read text messages because of visual impairment
  • Individuals with ongoing/current complications from spinal cord injury
  • Individuals with active cancer
  • Amputees
  • Individuals with unhealed fractures
  • Diabetics who do not have symptoms under control
  • Individuals who have visited a doctor for a fall in the last 6 months
  • Individuals with the diagnosis of schizophrenia

Sites / Locations

  • Tufts Medical Center
  • Brigham and Women's Hospital
  • Harvard University
  • New England Physiatry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

High Mindfulness

Low Mindfulness

Active control

Arm Description

All participants in this condition will complete all measures online at four different points in time, including one narrative response at T1. They will also be instructed to complete a mindfulness intervention at home and respond to diary-type text messaging questions (all including questions about pain) twice daily for six days.

All participants in this condition will complete all measures online at four different points in time, including one narrative response at T1. They will also be instructed to respond to diary-type text messaging questions (some related to pain) twice daily for six days.

All participants in this condition will complete all measures online at four different points in time, including one narrative response at T1. They will also be instructed to respond to diary-type text messaging questions (none about pain) twice daily for six days.

Outcomes

Primary Outcome Measures

Pain Beliefs and Perceptions Inventory (PBAPI)
The objective of the measure is to assess new pain believes. The scale includes 16 questions, each ranging from -2 to 2, with -2 being 'Strongly Disagree' and 2 being 'Strongly Agree.' There is no zero point on the scale. The 16-question measure includes four subscales, each containing four items. The subscales (Pain as Mystery, Pain as Constant, Pain as Permanent and Self-Blame) are scored individually by adding the score for each of the four items within a subscale together and then dividing that number by four. The subtotal for each one is then added to the others for a total scale score. Five items are reverse-scores, two of which are in the Pain as Constant subscale and the other three of which are in the Pain as Permanent Subscale. Final scores can range from -8 to 8.
Multidimensional Health Locus of Control Scale - Form C (MHLC-Form C)
The objective of the assessment is to measure health-related control beliefs in individuals with an current medical condition, such that scoring indicate the degree to which an individual believes their health is under their control versus the control of others or external forces. The scale includes 18 items, each ranging from 1-6, with 1 being 'Strongly Disagree' and 6 being 'Strongly Agree'. The scale includes four subscales including Internal, Chance, Doctors, and Other People. To determine overall scale score, sum all items from all subscales together for a final score between 18 and 108.
Brief Pain Inventory- Short Form
9-item scale measures pain severity and impact of pain on functional health. First item asks whether they have pain other than 'everyday' pain today (yes/No). Second question provides diagram of a person, asking one to point to pain and most pain. Next four items ask one to rate the worst, least, average and current pain over past 24 hours on a scale from 0 (No Pain)-10 (Pain As Bad As You Can Imagine). Item 7 asks about current pain treatments. Item 8 asks about % relief pain treatments provided over last 24 hours. %'s range from 0 (No Relief) to 100 (Complete Relief). Last item asks one to indicate pain interfering with 'General Activity,' 'Mood,' 'Walking ability,' 'Normal work,' 'Relations with other people,' 'Sleep,' and 'Enjoyment of life' over past 24 hours. Scales range from 0 (Does Not Interfere) to 10 (Completely Interferes). A mean composite score of items 3-6 yields pain severity. Other items are to be individually interpreted.
The MOS 36-Item Short-Form Health Survey (SF-36)
The objective of the measure is to survey health status. The assessment includes 36 items, with eight scaled scores from 8 separate dimensions, including 'Vitality,' 'Physical Functioning,' 'Bodily Pain,' 'General Health Perceptions,' 'Physical Role Functioning,' 'Emotional Role Functioning,' 'Social Role Functioning' and 'Mental Health.' Scores range from 0-100 with lower scores indicating more disability and higher score indicating less disability.

Secondary Outcome Measures

Pain Catastrophizing Scale (PCS)
The objective of the assessment is to measure catastrophic thinking related to pain. The tool asks individuals to endorse the degree to which they identified with certain thoughts or emotions surrounding their previous experiences of pain. The measure includes 13 items asking participants to rate their responses on a five-point likert scale ranging from 0 (not at all) to 4 (all the time). The measure consists of three subscales, including 'Rumination', 'Magnification' and 'Helplessness.' To score the measure, one is to sum up each of the subscales and then calculate the sum of the three subscales together. The subscales can also be individually interpreted.
Langer Mindfulness Scale- 14 item (LMS-14)
The assessment measures socio-cognitive mindfulness. The measure includes three subscales, each ranging from 1-7, with 1 being 'Strongly Disagree' and 7 being 'Strongly Agree'. Subscales are 'Novelty Seeking'; 'Novelty Producing'; 'Engagement'. Some items are reverse scored. To determine overall Mindfulness score, sum all items (items 1-14).

Full Information

First Posted
February 9, 2019
Last Updated
October 25, 2021
Sponsor
Harvard University
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1. Study Identification

Unique Protocol Identification Number
NCT03939949
Brief Title
Mindfully Attending to Pain Sensations
Official Title
Mindfully Attending to Pain Sensations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard 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
Substantial evidence suggests that psychosocial factors play a key role in explaining the risk for development of chronic pain, as well as for coping with it. Such factors include psychological perceptions or orientation towards pain, mainly referring to fear of pain and pain catastrophizing. Nonetheless, although this link is well documented, the underlying mechanisms of these processes have yet to be established. The "Attention to Variability" paradigm presents an explanatory mechanism, according to which the ability to mindfully attend to chronic symptoms enables and promotes increased control over the etiology and the expression of chronic symptoms. In support of the ATV paradigm, empirical findings demonstrate that ATV improved pregnancy outcomes and allowed people to gain control over fluctuations in their heart rates. The goal of the present study is to examine whether mindfully attending to pain sensations will decrease the intensity and frequency of chronic pain, increase perceived control of pain, and improve well-being and health-related quality of life.
Detailed Description
Participants who experience chronic pain will be randomly assigned to one of three experimental groups, which differ in the content and scheduling of text messages delivered over a period of six days. One third of participants will be assigned to the "active control" group. These participants will receive 2 text messages per day for six days (one at 9am and one at 9pm) asking them to report on the activity they are currently engaged in. One third of participants will be assigned to the "low mindfulness" group. These participants will receive the same text messages as the participants in the active control group, but will also be prompted with the 9pm text to report on pain intensity and unpleasantness at that time. One third of participants will be assigned to the "high mindfulness" group. These participants will also receive two text message prompts about their current activity. Participants in the "high mindfulness" group will also receive questions about current pain intensity and unpleasantness in both the morning and evening. In order to emphasize the variability in pain, participants will receive these text messages on a variable schedule. In addition, they will sent instructions every morning to pay attention to variability in their pain throughout the day and asked to report on how their pain is changing over time as a part of each text message prompt. The researchers will take measurements of pain interference, perceptions of control, and pain experience at three time points (T0=baseline, T1= immediately after the 6 days of text messages, T2= 1 month after T1, and T3= 3 months after T1). All surveys will be collected online via the Qualtrics.com platform.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
pain, mindfulness, awareness, attention to variability, quality of life, wellbeing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Masking Description
Participants are not aware of how the conditions differ, nor are they aware of how many conditions there are.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Mindfulness
Arm Type
Experimental
Arm Description
All participants in this condition will complete all measures online at four different points in time, including one narrative response at T1. They will also be instructed to complete a mindfulness intervention at home and respond to diary-type text messaging questions (all including questions about pain) twice daily for six days.
Arm Title
Low Mindfulness
Arm Type
Experimental
Arm Description
All participants in this condition will complete all measures online at four different points in time, including one narrative response at T1. They will also be instructed to respond to diary-type text messaging questions (some related to pain) twice daily for six days.
Arm Title
Active control
Arm Type
Active Comparator
Arm Description
All participants in this condition will complete all measures online at four different points in time, including one narrative response at T1. They will also be instructed to respond to diary-type text messaging questions (none about pain) twice daily for six days.
Intervention Type
Behavioral
Intervention Name(s)
High Mindfulness
Intervention Description
Those in the "high mindfulness" group will also receive questions about their current pain intensity and unpleasantness in both the morning and evening for six days. In order to emphasize the variability in pain, participants will receive these text messages on a variable schedule. In addition, they will sent instructions every morning to pay attention to variability in their pain throughout the day and asked to report on how their pain is changing over time as a part of each text message prompt.
Intervention Type
Behavioral
Intervention Name(s)
Low Mindfulness
Intervention Description
Those in the "low mindfulness" group, who will receive receive two text messages per day (one at at 9am and one at 9pm) for six days, each prompting them to write about the activity they are currently engaged in. They will also be prompted with the 9pm text to report on their pain intensity and unpleasantness at that time.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
Participants in the "active control" group will receive 2 text messages per day for six days (one at 9am and one at 9pm) asking them to report on the activity they are currently engaged in.
Primary Outcome Measure Information:
Title
Pain Beliefs and Perceptions Inventory (PBAPI)
Description
The objective of the measure is to assess new pain believes. The scale includes 16 questions, each ranging from -2 to 2, with -2 being 'Strongly Disagree' and 2 being 'Strongly Agree.' There is no zero point on the scale. The 16-question measure includes four subscales, each containing four items. The subscales (Pain as Mystery, Pain as Constant, Pain as Permanent and Self-Blame) are scored individually by adding the score for each of the four items within a subscale together and then dividing that number by four. The subtotal for each one is then added to the others for a total scale score. Five items are reverse-scores, two of which are in the Pain as Constant subscale and the other three of which are in the Pain as Permanent Subscale. Final scores can range from -8 to 8.
Time Frame
2 minutes
Title
Multidimensional Health Locus of Control Scale - Form C (MHLC-Form C)
Description
The objective of the assessment is to measure health-related control beliefs in individuals with an current medical condition, such that scoring indicate the degree to which an individual believes their health is under their control versus the control of others or external forces. The scale includes 18 items, each ranging from 1-6, with 1 being 'Strongly Disagree' and 6 being 'Strongly Agree'. The scale includes four subscales including Internal, Chance, Doctors, and Other People. To determine overall scale score, sum all items from all subscales together for a final score between 18 and 108.
Time Frame
3 minutes
Title
Brief Pain Inventory- Short Form
Description
9-item scale measures pain severity and impact of pain on functional health. First item asks whether they have pain other than 'everyday' pain today (yes/No). Second question provides diagram of a person, asking one to point to pain and most pain. Next four items ask one to rate the worst, least, average and current pain over past 24 hours on a scale from 0 (No Pain)-10 (Pain As Bad As You Can Imagine). Item 7 asks about current pain treatments. Item 8 asks about % relief pain treatments provided over last 24 hours. %'s range from 0 (No Relief) to 100 (Complete Relief). Last item asks one to indicate pain interfering with 'General Activity,' 'Mood,' 'Walking ability,' 'Normal work,' 'Relations with other people,' 'Sleep,' and 'Enjoyment of life' over past 24 hours. Scales range from 0 (Does Not Interfere) to 10 (Completely Interferes). A mean composite score of items 3-6 yields pain severity. Other items are to be individually interpreted.
Time Frame
2 minutes
Title
The MOS 36-Item Short-Form Health Survey (SF-36)
Description
The objective of the measure is to survey health status. The assessment includes 36 items, with eight scaled scores from 8 separate dimensions, including 'Vitality,' 'Physical Functioning,' 'Bodily Pain,' 'General Health Perceptions,' 'Physical Role Functioning,' 'Emotional Role Functioning,' 'Social Role Functioning' and 'Mental Health.' Scores range from 0-100 with lower scores indicating more disability and higher score indicating less disability.
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Pain Catastrophizing Scale (PCS)
Description
The objective of the assessment is to measure catastrophic thinking related to pain. The tool asks individuals to endorse the degree to which they identified with certain thoughts or emotions surrounding their previous experiences of pain. The measure includes 13 items asking participants to rate their responses on a five-point likert scale ranging from 0 (not at all) to 4 (all the time). The measure consists of three subscales, including 'Rumination', 'Magnification' and 'Helplessness.' To score the measure, one is to sum up each of the subscales and then calculate the sum of the three subscales together. The subscales can also be individually interpreted.
Time Frame
2 minutes
Title
Langer Mindfulness Scale- 14 item (LMS-14)
Description
The assessment measures socio-cognitive mindfulness. The measure includes three subscales, each ranging from 1-7, with 1 being 'Strongly Disagree' and 7 being 'Strongly Agree'. Subscales are 'Novelty Seeking'; 'Novelty Producing'; 'Engagement'. Some items are reverse scored. To determine overall Mindfulness score, sum all items (items 1-14).
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18+ Suffer from chronic pain (at least six months) Evaluate their usual level of pain in the last week as 4 and above (on a numeric rating scale from 0-10 with 0 indicating "No Pain" and 10 indicating "Worst pain imaginable) Fluent in English Owns a smartphone Exclusion Criteria: Individuals under the age of 18; Individuals who are not patients of our collaborating pain clinics or online chronic pain support groups and/or do not endorse their pain as chronic. Individuals who are pregnant Individuals with diagnosed cognitive impairment Individuals who would not be able to read text messages because of visual impairment Individuals with ongoing/current complications from spinal cord injury Individuals with active cancer Amputees Individuals with unhealed fractures Diabetics who do not have symptoms under control Individuals who have visited a doctor for a fall in the last 6 months Individuals with the diagnosis of schizophrenia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Bercovitz, MA
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karyn Gunnet-Shoval, PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen Langer, PhD
Organizational Affiliation
Harvard University
Official's Role
Study Director
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Harvard University
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Facility Name
New England Physiatry
City
Stoneham
State/Province
Massachusetts
ZIP/Postal Code
02180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10204746
Citation
Crombez G, Vlaeyen JW, Heuts PH, Lysens R. Pain-related fear is more disabling than pain itself: evidence on the role of pain-related fear in chronic back pain disability. Pain. 1999 Mar;80(1-2):329-39. doi: 10.1016/s0304-3959(98)00229-2.
Results Reference
background
PubMed Identifier
10781906
Citation
Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.
Results Reference
background
PubMed Identifier
2618067
Citation
Langer E, Drinka PJ, Voeks SK. Estimating nutritional intake in nursing home residents. Wis Med J. 1989 Dec;88(12):23-5. No abstract available.
Results Reference
background
PubMed Identifier
27007939
Citation
Zilcha-Mano S, Langer E. Mindful Attention to Variability Intervention and Successful Pregnancy Outcomes. J Clin Psychol. 2016 Sep;72(9):897-907. doi: 10.1002/jclp.22294. Epub 2016 Mar 23.
Results Reference
background
PubMed Identifier
27586832
Citation
Edwards RR, Dworkin RH, Sullivan MD, Turk DC, Wasan AD. The Role of Psychosocial Processes in the Development and Maintenance of Chronic Pain. J Pain. 2016 Sep;17(9 Suppl):T70-92. doi: 10.1016/j.jpain.2016.01.001.
Results Reference
background
PubMed Identifier
28658194
Citation
Tsur N, Defrin R, Ginzburg K. Posttraumatic Stress Disorder, Orientation to Pain, and Pain Perception in Ex-Prisoners of War Who Underwent Torture. Psychosom Med. 2017 Jul/Aug;79(6):655-663. doi: 10.1097/PSY.0000000000000461.
Results Reference
background

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Mindfully Attending to Pain Sensations

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