Mindfully Attending to Pain Sensations

President and Fellows of Harvard College

Status: Unknown

Conditions: Chronic Pain

Treatments: Behavioral: Low Mindfulness; Behavioral: High Mindfulness; Behavioral: Active Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03939949

IRB17-1861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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300 participants in 3 patient groups

High Mindfulness

Experimental group

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.

Treatment:

Behavioral: High Mindfulness

Low Mindfulness

Experimental group

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.

Treatment:

Behavioral: Low Mindfulness

Active control

Active Comparator group

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.

Treatment:

Behavioral: Active Control