Clinical trial NCT06957743: Mechanisms of Mindfulness Meditation and Self-Hypnosis for Pain in Older Adults With Chronic Pain
Official title: Mechanisms of Mindfulness Meditation and Self-Hypnosis for Pain in Older Adults With Chronic Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Mindfulness Meditation
Self-Hypnosis
Keywords: Chronic Pain
Mindfulness Meditation
Self-Hypnosis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: The University of Queensland
name: University of Florida
name: University of California, San Diego
name: National Institute on Aging (NIA)
First posted: 2025-05-04
Enrollment: 375
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 (\<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).

Primary outcomes:
measure: Change in average chronic pain intensity in past 24 hours
timeFrame: 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
Secondary outcomes:
measure: Change in pain threshold
timeFrame: Collected during EEG procedure, baseline MRI/fMRI assessment, and 1-week post-baseline MRI/fMRI assessment
measure: Change in pain tolerance
timeFrame: Collected during EEG procedure, baseline MRI/fMRI assessment, and 1-week post-baseline MRI/fMRI assessment
measure: Change in peak experiment-induced pain intensity
timeFrame: Collected during EEG procedure, baseline MRI/fMRI assessment, and 1-week post-baseline MRI/fMRI assessment
measure: Change in peak experiment-induced pain unpleasantness
timeFrame: Collected during EEG assessment visit, baseline MRI/fMRI assessment, and 1-week post-baseline MRI/fMRI assessment
measure: Change in current pain intensity
timeFrame: Collected during EEG procedure, baseline MRI/fMRI assessment, at each of the 4 treatment sessions, and at 1-week post-baseline MRI/fMRI assessment
measure: Change in current pain unpleasantness
timeFrame: 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
measure: Change in average chronic pain unpleasantness in past 24 hours
timeFrame: Collected daily for 4 consecutive days at pre-baseline, and daily for 4 consecutive days starting day 11 post-baseline MRI/fMRI assessment
measure: Change in pain interference
timeFrame: Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment
measure: Change in sleep disturbance
timeFrame: Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment
measure: Change in depression
timeFrame: Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment
measure: Change in fatigue
timeFrame: Collected once at pre-baseline, and once on day 13 post-baseline MRI/fMRI assessment
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Mark Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Queensland
name: Melissa Day, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Patterson DR, Jensen MP. Hypnosis and clinical pain. Psychol Bull. 2003 Jul;129(4):495-521. doi: 10.1037/0033-2909.129.4.495.
citation: 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.
citation: 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.
citation: 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.
citation: 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.