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

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Mindfulness Meditation; Self-Hypnosis

• Registration Number: NCT06957743
• Lead Sponsor: University of Washington

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. evaluate fMRI of adults receiving psychological treatments for chronic pain relative to an attention control condition 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. Self-Hypnosis

3. Audio Recording Control

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 Self-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 be asked to attend 7 sessions and complete assessments in-person and online. Study sessions will consist of EEG assessment (in-person session 1), self-report measures (mixed in-person and online, all sessions), MRI and fMRI with concurrent experimental pain stimulation via heat and mechanical pain induction (in-person sessions 2 and 7) and Mindfulness-Meditation or Self-Hypnosis practice (in-person session 7 only), as well as training in Mindfulness-Meditation, Self-Hypnosis, or audio recording control (online sessions 3-6). Participants will spend about 6.5 hours in this study over a 3-week period.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study Start: 2025-05
• Study First Submitted QC: 2025-05-01
• Last Update Submitted: 2025-05-01
• Study First Posted: 2025-05-04
• Last Update Posted: 2025-05-04
• Primary Completion: 2029-03
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 375

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 (<20-min. practice/week over the past 6-months; never attended a mindfulness or self-hypnosis course); and
6. if currently taking analgesic or psychotropic medication, medication must have been stabilized for ≥4-weeks prior to this study.

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 metals in the body (e.g., clips, prosthetics, pace-makers);
3. self-report claustrophobia or other contraindications to MRI scanning;
4. have uncontrolled hypertension;
5. have a primary chronic pain condition of headache;
6. show signs of cognitive impairment (6-Item Cognitive Screener during screening; MoCA score at Session 1, using demographically-adjusted normative cut-offs that take into account race, ethnicity, and age);
7. have chronic pain due to malignancy (e.g., cancer) or a chronic pain condition for which surgery is recommended and/or planned;
8. are currently receiving other psychosocial treatments for any pain condition (as this may influence these treatment results);
9. self-report previous participation in an experimental pain study; or
10. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in average chronic pain intensity in past 24 hours	Collected daily for 4 consecutive days at pre-baseline, once at 1-week post-baseline MRI/fMRI assessment, 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.

Secondary Outcome Measures

Name	Time	Method
Change in sleep disturbance	Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment	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.
Change in pain tolerance	Collected during EEG procedure, baseline MRI/fMRI assessment, and 1-week post-baseline MRI/fMRI assessment	Change in pain tolerance will be measured by noting the point at which the stimulus (temperature/pressure) is discontinued.
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 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.
Change in depression	Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment	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.
Change in fatigue	Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment	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.
Change in pain threshold	Collected during EEG procedure, baseline MRI/fMRI assessment, and 1-week post-baseline MRI/fMRI assessment	Change in pain threshold will be measured by noting the point at which the stimulus (temperature/pressure) is detected as 'painful'.
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 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.
Change in current pain intensity	Collected during EEG procedure, baseline MRI/fMRI assessment, at each of the 4 treatment sessions, and at 1-week post-baseline MRI/fMRI assessment	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.
Change in current pain unpleasantness	Collected during EEG assessment visit, baseline MRI/fMRI assessment, at each of the 4 treatment sessions, and at 1-week post-baseline MRI/fMRI assessment	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.
Change in average chronic pain unpleasantness in past 24 hours	Collected daily for 4 consecutive days at pre-baseline, and daily for 4 consecutive days starting day 11 post-baseline MRI/fMRI assessment	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.
Change in pain interference	Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment	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.