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

N/ANot Yet RecruitingNCT06957743

University of Washington375 enrolled

Overview

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. Therapeutic Hypnosis 3. Story Listening

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 learn Mindfulness Meditation skills, Therapeutic Hypnosis skills, or listen to staff read text from a book. Participants will spend about 8 hours in this study over a 4-week period.

Study Type

INTERVENTIONAL

Interventions

Mindfulness MeditationBEHAVIORAL

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 the clinician read a standardized Mindfulness Meditation script.

Therapeutic HypnosisBEHAVIORAL

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 the clinician read a standardized 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 ListeningBEHAVIORAL

Participants will listen to four, 20-min. excerpts from a natural history book. Participants will lie flat on their back and will listen to the clinician read the standardized book excerpt.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

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.

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

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.

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

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.

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

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.

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.

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

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.

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

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.

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

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.

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

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts