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

NCT06957743 | Recruiting DMC

• 2 other identifiers: STUDY00021167R01AG079832-01
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.evaluate fMRI of adults receiving psychological treatments for chronic pain to determine how these interventions work within older adults, and
2. 2.examine self-report and EEG variables to identify for whom do these psychological interventions work.
3. 3.Mindfulness-Meditation
4. 4.Therapeutic Hypnosis
5. 5.Story Listening

Conditions

Chronic Pain

Keywords

Chronic Pain; Mindfulness Meditation; Therapeutic Hypnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in peak experiment-induced 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

  Collected during EEG assessment visit, baseline MRI/fMRI assessment, and 1-week post-baseline MRI/fMRI assessment

• Change in current pain intensity

  Collected during EEG procedure, baseline MRI/fMRI assessment, and at 1-week post-baseline MRI/fMRI assessment

• Change in current 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

  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

Study Arms (3)

Mindfulness Meditation

EXPERIMENTAL

Participants will lie flat on their back with their eyes closed and will listen to a recorded Mindfulness Meditation script.

Behavioral: Mindfulness Meditation

Therapeutic Hypnosis

EXPERIMENTAL

Participants will lie flat on their back with their eyes closed and will listen to a recorded hypnotic script.

Behavioral: Therapeutic Hypnosis

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.

Behavioral: Story Listening

Interventions

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.

Mindfulness Meditation

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).

Therapeutic Hypnosis

Story Listening BEHAVIORAL

Participants will lie flat on their back and will listen to a recorded story from a natural history book.

Story Listening

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;
• 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.

You may not qualify if:

• have a history of a medical condition that could produce an abnormal EEG (e.g., epilepsy, history of traumatic brain injury);
• 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;
• have metals in the body (e.g., pacemakers and/or cochlear implant) that are not allowed by IBIC MRI technicians;
• self-report claustrophobia or other contraindications to MRI scanning;
• have uncontrolled hypertension;
• have a primary chronic pain condition of headache;
• have chronic pain due to malignancy (e.g., cancer) or a chronic pain condition for which surgery is recommended and/or planned;
• 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.
• 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);
• currently receiving other psychosocial treatments for any pain condition (as this may influence these treatment results);
• self-report previous participation in an experimental pain study;
• 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);
• unstable medical or psychiatric condition (e.g., mania, psychotic symptoms) that would interfere with study participation; or
• active suicidal ideation/intent indicating significant risk.

Sponsors & Collaborators

• University of California, San Diego: collaborator
• National Institute on Aging (NIA): collaborator
• University of Washington: lead
• The University of Queensland: collaborator
• University of Florida: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 24547802 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.

  PMID: 12848218 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.

  PMID: 32483058 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.

  PMID: 32302791 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.

  PMID: 38609994 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.

  PMID: 26903081 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mark Jensen, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Melissa Day, PhD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana Salem, MA

CONTACT

206-543-0107; rsalem@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Rehabilitation Medicine

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: May 4, 2025
• Study Start: March 4, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (1)