How mindfulness meditation and self-hypnosis affect chronic pain in older adults

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

This study tests whether mindfulness meditation or therapeutic hypnosis can reduce pain in people aged 60 and older with chronic pain, compared with listening to recorded stories.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 375 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: University of Washington (Academic / other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT06957743 on ClinicalTrials.gov

What this trial studies

Older adults with chronic pain are randomly assigned to one of three groups: mindfulness meditation, therapeutic hypnosis, or a story-listening control. Participants complete three in-person visits (including EEG and structural and functional MRI) and four remote at-home sessions, plus online surveys before and after the intervention. The study combines brain imaging, EEG, and self-report measures to identify how each intervention changes brain activity and who is most likely to benefit. Results aim to clarify neural mechanisms and predictors of response in people 60+ with chronic pain.

Who should consider this trial

Good fit: Ideal candidates are English-speaking adults aged 60 or older who have had chronic pain for at least three months, report average pain ≥3/10, and have little or no recent experience with meditation or hypnosis.

Not a fit: People with unstable medication regimens, recent formal meditation or hypnosis training, inability to undergo MRI (for example due to metal implants or severe claustrophobia), or who cannot travel to Seattle for in-person visits may not receive benefit or be eligible.

Why it matters

Potential benefit: If successful, the study could help match older adults with the psychological treatment—mindfulness or hypnosis—that is most likely to reduce their chronic pain and improve quality of life.

How similar studies have performed: Prior trials have shown that mindfulness and therapeutic hypnosis can help reduce chronic pain, but using fMRI and EEG to pinpoint brain mechanisms and predictors of response in older adults is less well established.

Eligibility criteria

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.

Where this trial is running

Seattle, Washington

• University of Washington — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Mark Jensen, PhD — University of Washington
• Study coordinator: Rana Salem, MA

Conditions Chronic Pain; Mindfulness Meditation; Therapeutic Hypnosis