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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Mindfully Attending to Pain Sensations

Clinicaltrials.gov identifier NCT03939949

Recruitment Status Active, not recruiting

First Posted May 7, 2019

Last update posted September 11, 2019

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.

  • Condition or Disease:Chronic Pain
  • Intervention/Treatment: Behavioral: High Mindfulness
    Behavioral: Low Mindfulness
    Behavioral: Active Control
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 300 participants
  • Allocation: Randomized
  • Intervention Model: Factorial Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Basic Science
  • Official Title: Mindfully Attending to Pain Sensations
  • Actual Study Start Date: April 2018
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: December 2019
Arms and interventions
Arm Intervention/treatment
Experimental: High Mindfulness
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.
Behavioral: High Mindfulness
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.
Experimental: Low Mindfulness
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.
Behavioral: Low Mindfulness
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.
Active Comparator: Active control
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.
Behavioral: Active Control
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.
Outcome Measures
  • Primary Outcome Measures: 1. Pain Beliefs and Perceptions Inventory (PBAPI) [ Time Frame: 2 minutes ]
    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.
  • 2. Multidimensional Health Locus of Control Scale - Form C (MHLC-Form C) [ Time Frame: 3 minutes ]
    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.
  • 3. Brief Pain Inventory- Short Form [ Time Frame: 2 minutes ]
    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.
  • 4. The MOS 36-Item Short-Form Health Survey (SF-36) [ Time Frame: 3 minutes ]
    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: 1. Pain Catastrophizing Scale (PCS) [ Time Frame: 2 minutes ]
    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.
  • 2. Langer Mindfulness Scale- 14 item (LMS-14) [ Time Frame: 2 minutes ]
    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).
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

United States, Massachusetts
Tufts Medical Center
Boston

United States, Massachusetts
Brigham and Women's Hospital
Boston

United States, Massachusetts
Harvard University
Cambridge

United States, Massachusetts
New England Physiatry
Stoneham

Sponsors and Collaborators

Harvard University

Investigators

Study Director: Ellen Langer, PhD Harvard University

Principal Investigator: Katherine Bercovitz, MA Harvard University

Principal Investigator: Karyn Gunnet-Shoval, PhD Harvard University

More Information