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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG079832-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The University of Queensland | OTHER |
| University of Florida | OTHER |
| University of California, San Diego | OTHER |
| National Institute on Aging (NIA) |
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The goal of this study is to better understand how two common psychological treatments for pain work in the brain of older adults living with chronic pain. This study will:
Adults ages 60 years and older, living with chronic pain for at least 3 months will be randomly assigned to one of three conditions:
Research has shown that psychological treatments can help people with chronic pain manage their pain and improve their quality of life. Two common psychological treatments for chronic pain include Mindfulness-Meditation and Therapeutic Hypnosis. While research has shown these treatments are helpful for people with chronic pain, the benefits people experience from these types of treatments can vary from person to person. There is little research showing who responds best to which treatments and what happens in the brain during these treatments to reduce pain. The purpose of this study is to better understand how these pain treatments work in the brain. By identifying how these pain treatments work to help reduce chronic pain, the study investigators aim to improve treatments for people with chronic pain in the future.
Participants will complete seven study sessions (three in-person at the University of Washington Medical Center and four remote (e.g., at-home)). Sessions will vary from 45 minutes to 2 hours. They will also be asked to complete four online surveys before they start the study sessions and four online surveys after they complete the study sessions.
Participants will spend about 8 hours in this study over a 4-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Meditation | Experimental | Participants will lie flat on their back with their eyes closed and will listen to a recorded Mindfulness Meditation script. |
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| Therapeutic Hypnosis | Experimental | Participants will lie flat on their back with their eyes closed and will listen to a recorded hypnotic script. |
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| Story Listening | Experimental | Participants will lie flat on their back with their eyes closed and will listen to a recorded story from a natural history book. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Meditation | Behavioral | The Mindfulness Meditation trainings will teach participants Shamatha Vipassana, which is the specific form of Mindfulness Meditation typically implemented in mindfulness research. The emphasis is placed upon developing focused attention on an object of awareness, such as the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Participants will be invited to lie flat on their back (i.e., to mimic conditions in the MRI scanner) and will listen to a recorded Mindfulness Meditation script. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average chronic pain intensity in past 24 hours | Change in average chronic pain intensity in the past 24 hours will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their chronic pain intensity in the past 24 hours. Higher scores indicate higher levels of self-reported pain intensity. The four daily assessments will be averaged and change scores will be calculated between pre- and post-treatment. | Collected daily for 4 consecutive days at pre-baseline, during EEG procedure, baseline MRI/fMRI assessment, at each of the 4 treatment sessions, 1-week post-baseline MRI, and daily for 4 consecutive days starting day 11 post-baseline MRI/fMRI assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak experiment-induced pain intensity | Change in pain intensity will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their current pain intensity as assessed during the pain stimulus session; the question is asked at the point that pain tolerance is reached. Higher scores indicate higher levels of self-reported pain intensity. |
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Inclusion Criteria:
be ≥60 years of age;
have self-reported chronic pain (≥3-months, with pain experienced on ≥ 50% of days);
endorse an average intensity of pain ≥3 on a 0-10 numerical rating scale (NRS) for most days of the previous 3-months;
be able to read, speak, and understand English;
be naïve to meditation and hypnosis:
if currently taking analgesic or psychotropic medication, medication must have been stabilized for ≥4-weeks prior to this study and does not anticipate changes in the medication during the study;
access to a private place with adequate internet reception to support participation in intervention training sessions;
not currently participating in another clinical trial or interventional study for chronic pain and willing to refrain from participation in any other clinical trial or interventional study for chronic pain during active participation in this study;
willing, able, and committed to participate in an in-person EEG, and two MRI/fMRI scans; and
able to use an electronic device (e.g., smart phone, tablet, computer) independently to access email and webpages or have someone available in their home who can help them with initial session set-up and then leave for the treatment sessions.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rana Salem, MA | Contact | 206-543-0107 | rsalem@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark Jensen, PhD | University of Washington | Principal Investigator |
| Melissa Day, PhD | The University of Queensland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Recruiting | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24547802 | Background | Jensen MP, Patterson DR. Hypnotic approaches for chronic pain management: clinical implications of recent research findings. Am Psychol. 2014 Feb-Mar;69(2):167-77. doi: 10.1037/a0035644. | |
| 12848218 | Background | Patterson DR, Jensen MP. Hypnosis and clinical pain. Psychol Bull. 2003 Jul;129(4):495-521. doi: 10.1037/0033-2909.129.4.495. |
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The self-report data and metadata will be archived in the Mendeley Data generalist repository. The EEG and fMRI data will be archived in the NeuroImaging Tools & Resources Collaboratory Image Repository (NTRC-IR), which is a NIH-sponsored repository for neuroimaging data.
All data will be archived by the time that the award ends. The data will be preserved in the repositories for as long as those repositories continue to exist and curate the data.
At two years after the end of the project period or after the primary study papers have been published, whichever comes first, access to the data will be granted following completion of a data management and sharing plan agreement with the Department of Rehabilitation Medicine at the University of Washington. Two years after the end of the project period or after the primary study papers have been published, all of the study data will be available to scientists without these scientists needing to complete and sign the UW Department of Rehabilitation's data sharing plan agreement.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| NIH |
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| Therapeutic Hypnosis | Behavioral | In the Therapeutic Hypnosis group, participants will relax with their eyes closed and, as with Mindfulness Meditation, will lie flat on their lack and will listen to a recorded hypnotic script. The Therapeutic Hypnosis practice will include an induction followed by suggestions for decreased pain and improvement in comorbid symptoms (e.g., mood). |
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| Story Listening | Behavioral | Participants will lie flat on their back and will listen to a recorded story from a natural history book. |
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| Collected during EEG procedure, baseline MRI/fMRI assessment, and 1-week post-baseline MRI/fMRI assessment |
| Change in peak experiment-induced pain unpleasantness | Change in pain unpleasantness will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their current pain unpleasantness as assessed during the pain stimulus session; the question is asked at the point that pain tolerance is reached. Higher scores indicate higher levels of self-reported pain unpleasantness. | Collected during EEG assessment visit, baseline MRI/fMRI assessment, and 1-week post-baseline MRI/fMRI assessment |
| Change in current pain intensity | Change in current pain intensity will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their current pain intensity. Higher scores indicate higher levels of self-reported pain intensity. | Collected during EEG procedure, baseline MRI/fMRI assessment, and at 1-week post-baseline MRI/fMRI assessment |
| Change in current pain unpleasantness | Change in current pain unpleasantness will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their current pain unpleasantness. Higher scores indicate higher levels of self-reported pain unpleasantness. | Collected during EEG assessment visit, baseline MRI/fMRI assessment, and at 1-week post-baseline MRI/fMRI assessment |
| Change in average chronic pain unpleasantness in past 24 hours | Change in average chronic pain unpleasantness in the past 24 hours will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their chronic pain unpleasantness in the past 24 hours. Higher scores indicate higher levels of self-reported pain unpleasantness. | Collected daily for 4 consecutive days at pre-baseline, during EEG procedure, baseline MRI/fMRI assessment, at each of the 4 treatment sessions, 1-week post-baseline MRI, and daily for 4 consecutive days starting day 11 post-baseline MRI/fMRI assessment |
| Change in pain interference | Change in pain interference with different activities/aspects of life will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4-item short form. Responses from each item will be summed for a total raw score from 4-20. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. | Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment |
| Change in sleep disturbance | Change in sleep disturbance will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 4-item short form. Responses from each item will be summed to form a total raw score ranging from 4-20. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported sleep disturbance. | Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment |
| Change in depression | Change in depression will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4-item short form. Responses from each item will be summed to form a total raw score ranging from 4-20. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher self-reported levels of depression. | Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment |
| Change in fatigue | Change in fatigue will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 4-item short form. Responses from each item will be summed to form a total raw score ranging from 4-20. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher self-reported levels of fatigue. | Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment |
| 32483058 | Background | Jensen MP, Mendoza ME, Ehde DM, Patterson DR, Molton IR, Dillworth TM, Gertz KJ, Chan J, Hakimian S, Battalio SL, Ciol MA. Effects of hypnosis, cognitive therapy, hypnotic cognitive therapy, and pain education in adults with chronic pain: a randomized clinical trial. Pain. 2020 Oct;161(10):2284-2298. doi: 10.1097/j.pain.0000000000001943. |
| 32302791 | Background | Day MA, Ehde DM, Burns J, Ward LC, Friedly JL, Thorn BE, Ciol MA, Mendoza E, Chan JF, Battalio S, Borckardt J, Jensen MP. A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol. Contemp Clin Trials. 2020 Jun;93:106000. doi: 10.1016/j.cct.2020.106000. Epub 2020 Apr 14. |
| 38609994 | Background | Day MA, Ciol MA, Mendoza ME, Borckardt J, Ehde DM, Newman AK, Chan JF, Drever SA, Friedly JL, Burns J, Thorn BE, Jensen MP. The effects of telehealth-delivered mindfulness meditation, cognitive therapy, and behavioral activation for chronic low back pain: a randomized clinical trial. BMC Med. 2024 Apr 12;22(1):156. doi: 10.1186/s12916-024-03383-2. |
| 26903081 | Background | Morone NE, Greco CM, Moore CG, Rollman BL, Lane B, Morrow LA, Glynn NW, Weiner DK. A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):329-37. doi: 10.1001/jamainternmed.2015.8033. |