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Chronic PainNCT06957743

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

A study testing Mindfulness Meditation, Therapeutic Hypnosis and Story Listening in people with Chronic Pain, run by University of Washington at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. evaluate fMRI of adults receiving psychological treatments for chronic pain to determine how these interventions work within older adults, and… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Mindfulness Meditation, Therapeutic Hypnosis and Story Listening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
1 siteUnited States
Study dates
4 Mar 2026to 31 Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rana Salem, MA contact

206-543-0107

rsalem@uw.edu

United States1 site, 1 recruiting

  • University of Washington

    Seattle, Washington, 98104

    Brianna Agnew, 844-481-3451, reframe-study@uw.edu

    Emily Cornejo, 844-481-3451, reframe-study@uw.edu

    Recruiting

Other trials in United States

About this study

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
Read the 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.

Conditions
Chronic Pain
Being tested
Mindfulness Meditation, Therapeutic Hypnosis, Story Listening
Keywords
Chronic Pain, Mindfulness Meditation, Therapeutic Hypnosis
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness MeditationBehavioural

    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.

  • Therapeutic HypnosisBehavioural

    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).

  • Story ListeningBehavioural

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

Study groups in NCT06957743
Study groupRoleWhat they receive
Mindfulness MeditationExperimentalParticipants will lie flat on their back with their eyes closed and will listen to a recorded Mindfulness Meditation script.
Receives: Behavioral: Mindfulness Meditation
Therapeutic HypnosisExperimentalParticipants will lie flat on their back with their eyes closed and will listen to a recorded hypnotic script.
Receives: Behavioral: Therapeutic Hypnosis
Story ListeningExperimentalParticipants will lie flat on their back with their eyes closed and will listen to a recorded story from a natural history book.
Receives: Behavioral: Story Listening

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

    Measured: 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

  6. 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.

    Measured: Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment

  7. 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.

    Measured: Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment

  8. 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.

    Measured: Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment

  9. 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.

    Measured: Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2025
  2. Study start4 Mar 2026
  3. Primary completion1 Mar 2029 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
375 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06957743
Sponsor's protocol ID
STUDY00021167
Other IDs
R01AG079832-01
Status last verified
Jun 2026
First submitted
10 Apr 2025
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 24547802

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

    PubMed 12848218

  • 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.

    PubMed 32483058

  • 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.

    PubMed 32302791

  • 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.

    PubMed 38609994

  • 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.

    PubMed 26903081

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Meditation, Therapeutic Hypnosis and Story Listening in people with Chronic Pain, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rana Salem, MA (206-543-0107, rsalem@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in average chronic pain intensity in past 24 hours (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06957743, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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