Clinical trial NCT03939949: Mindfully Attending to Pain Sensations
Official title: Mindfully Attending to Pain Sensations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: pain
mindfulness
awareness
attention to variability
quality of life
wellbeing
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Pain Beliefs and Perceptions Inventory (PBAPI)
timeFrame: 2 minutes
measure: Multidimensional Health Locus of Control Scale - Form C (MHLC-Form C)
timeFrame: 3 minutes
measure: Brief Pain Inventory- Short Form
timeFrame: 2 minutes
measure: The MOS 36-Item Short-Form Health Survey (SF-36)
timeFrame: 3 minutes
Secondary outcomes:
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 2 minutes
measure: Langer Mindfulness Scale- 14 item (LMS-14)
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
city: Stoneham
country: United States
facility: New England Physiatry
state: Massachusetts
Study officials:
affiliation: Harvard University
name: Katherine Bercovitz, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Karyn Gunnet-Shoval, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Ellen Langer, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.