Mechanisms of Mindfulness Meditation and Self-Hypnosis for Pain in Older Adults With Chronic Pain

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:

1. evaluate fMRI of adults receiving psychological treatments for chronic pain to determine how these interventions work within older adults, and
2. examine self-report and EEG variables to identify for whom do these psychological interventions work.

Adults ages 60 years and older, living with chronic pain for at least 3 months will be randomly assigned to one of three conditions:

1. Mindfulness-Meditation
2. Therapeutic Hypnosis
3. Story Listening

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Mindfulness Meditation; Behavioral: Therapeutic Hypnosis; Behavioral: Story Listening

Detailed Description

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.

• 3 in-person sessions: the study includes one session where participants will receive an electroencephalogram (EEG; to assess brain wave activity). It also includes two sessions where they will receive structural MRIs (to image their brain) and functional MRIs (to image their brain while they are at rest and while we test how they respond to heat stimulus). Participants will be asked questions about their quality of life and their pain.
• 4 remote (at-home) sessions: participants will be randomized to listen to recordings of Mindfulness Meditation, Therapeutic Hypnosis, or a story.

Participants will spend about 8 hours in this study over a 4-week period.

• Study Type: Interventional
• Enrollment (Estimated): 375
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rana Salem, MA; Phone Number: 206-543-0107; Email: rsalem@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • University of Washington
      • Contact: Brianna Agnew; Phone Number: 844-481-3451; Email: reframe-study@uw.edu
      • Contact: Emily Cornejo; Phone Number: 844-481-3451; Email: reframe-study@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. be ≥60 years of age;
2. have self-reported chronic pain (≥3-months, with pain experienced on ≥ 50% of days);
3. endorse an average intensity of pain ≥3 on a 0-10 numerical rating scale (NRS) for most days of the previous 3-months;
4. be able to read, speak, and understand English;

5. be naïve to meditation and hypnosis:

   • never received formal training in or attended a mindfulness meditation or therapeutic hypnosis course;
   • have not practiced meditation (e.g., mindfulness meditation, Zen, Buddhism, or meditation applications such as certain types of CALM meditation; or therapeutic hypnosis (e.g., hypnosis applications) in the past 6-months;
   • <20-min. practice/week of meditation or therapeutic hypnosis (not described above) over the past 6-months;
6. 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;
7. access to a private place with adequate internet reception to support participation in intervention training sessions;
8. 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;
9. willing, able, and committed to participate in an in-person EEG, and two MRI/fMRI scans; and
10. 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:

1. have a history of a medical condition that could produce an abnormal EEG (e.g., epilepsy, history of traumatic brain injury);
2. have an EEG confounder (e.g., congenital or acquired skull defects, missing sections or holes in the skull, or plates, screws, or other implants within the skull or brain) that would interfere with reliable EEG data collection;
3. have metals in the body (e.g., pacemakers and/or cochlear implant) that are not allowed by IBIC MRI technicians;
4. self-report claustrophobia or other contraindications to MRI scanning;
5. have uncontrolled hypertension;
6. have a primary chronic pain condition of headache;
7. have chronic pain due to malignancy (e.g., cancer) or a chronic pain condition for which surgery is recommended and/or planned;
8. alcohol abuse (operationalized as scoring ≥5 (male) or ≥4 (female) and responds that they have three or more standard drinks on a typical day or they have six or more drinks on one occasion less than monthly or greater on the Alcohol Use Disorders Identification Test-Concise (AUDIT-C), or any substance (drug) abuse, all of which may impact EEG measures.
9. severe cognitive impairment defined as ≥2 errors on the 6-Item Cognitive Impairment test or show signs of cognitive impairment on the Montreal Cognitive Assessment (MoCA, using demographically-adjusted normative cut-offs that take into account race, ethnicity, age, and educational attainment);
10. currently receiving other psychosocial treatments for any pain condition (as this may influence these treatment results);
11. self-report previous participation in an experimental pain study;
12. report <2 on a 0-10 NRS for pain intensity in response to experimental "heat" pain stimuli (in order to avoid floor effects and to ensure participants are not too insensitive to thermal pain to reliably produce detectable pain-related brain activation);
13. unstable medical or psychiatric condition (e.g., mania, psychotic symptoms) that would interfere with study participation; or
14. active suicidal ideation/intent indicating significant risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Meditation; Participants will lie flat on their back with their eyes closed and will listen to a recorded Mindfulness Meditation script.	Behavioral: Mindfulness Meditation; 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.
Experimental: Therapeutic Hypnosis; Participants will lie flat on their back with their eyes closed and will listen to a recorded hypnotic script.	Behavioral: Therapeutic Hypnosis; 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).
Experimental: Story Listening; Participants will lie flat on their back with their eyes closed and will listen to a recorded story from a natural history book.	Behavioral: Story Listening; Participants will lie flat on their back and will listen to a recorded story from a natural history book.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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 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
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: University of California, San Diego; National Institute on Aging (NIA); University of Florida; The University of Queensland
• Investigators: Principal Investigator: Mark Jensen, PhD, University of Washington; Principal Investigator: Melissa Day, PhD, The University of Queensland

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Patterson DR, Jensen MP. Hypnosis and clinical pain. Psychol Bull. 2003 Jul;129(4):495-521. doi: 10.1037/0033-2909.129.4.495.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Mindfulness Meditation; Therapeutic Hypnosis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness
• Other Study ID Numbers: STUDY00021167; R01AG079832-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No