Mindfully Attending to Pain Sensations

Chronic Pain Clinical Trial

Official title:

Mindfully Attending to Pain Sensations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03939949
• Other study ID #: IRB17-1861
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: Harvard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.
• 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 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Harvard University	Cambridge	Massachusetts
United States	New England Physiatry	Stoneham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard University

Country where clinical trial is conducted

United States, 

References & 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. — View 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. Review. — View Citation

Langer E, Drinka PJ, Voeks SK. Estimating nutritional intake in nursing home residents. Wis Med J. 1989 Dec;88(12):23-5. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	2 minutes
Secondary	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).	2 minutes

External Links

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