Mindfully Attending to Pain Sensations

NCT03939949 | Completed

• 1 other identifier: IRB17-1861
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Pain

Keywords

pain; mindfulness; awareness; attention to variability; quality of life; wellbeing

Outcome Measures

Primary Outcomes (4)

• 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.

  2 minutes

• 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.

  3 minutes

• 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.

  2 minutes

• 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.

  3 minutes

Secondary Outcomes (2)

• Pain Catastrophizing Scale (PCS)

  2 minutes

• Langer Mindfulness Scale- 14 item (LMS-14)

  2 minutes

Study Arms (3)

High Mindfulness

EXPERIMENTAL

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

Low Mindfulness

EXPERIMENTAL

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

Active control

ACTIVE COMPARATOR

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

Interventions

High Mindfulness BEHAVIORAL

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.

High Mindfulness

Low Mindfulness BEHAVIORAL

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.

Low Mindfulness

Active Control BEHAVIORAL

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.

Active control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard University: lead

Study Sites (4)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

New England Physiatry

Stoneham, Massachusetts, 02180, United States

Location

Related Publications (6)

• 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.

  PMID: 10204746 BACKGROUND

• 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.

  PMID: 10781906 BACKGROUND

• 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.

  PMID: 2618067 BACKGROUND

• 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.

  PMID: 27007939 BACKGROUND

• 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.

  PMID: 27586832 BACKGROUND

• 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.

  PMID: 28658194 BACKGROUND

Related Links

• Additional Reference

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ellen Langer, PhD

  Harvard University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not aware of how the conditions differ, nor are they aware of how many conditions there are.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: February 9, 2019
• First Posted: May 7, 2019
• Study Start: April 20, 2018
• Primary Completion: December 18, 2019
• Study Completion: January 29, 2021
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)