NCT06957743 · University of Washington
Mechanisms of Mindfulness Meditation and Self-Hypnosis for Pain in Older Adults With Chronic Pain
What this study is about
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.
View original scientific description
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.
Interventions
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.
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).
BEHAVIORAL
Story Listening
Participants will lie flat on their back and will listen to a recorded story from a natural history book.
Primary outcome measures
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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.
Exclusion criteria
- 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.
Where
- Seattle, Washington
Collaborators
The University of Queensland, University of Florida, University of California, San Diego, National Institute on Aging (NIA)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations