Summary

Eligibility
for people ages 60 years and up (full criteria)
Dates
study started
study ends around

Description

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. Therapeutic Hypnosis
  3. Story Listening

Details

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.

Keywords

Chronic Pain, Mindfulness Meditation, Therapeutic Hypnosis, Mindfulness, Story Listening

Eligibility

You can join if…

Open to people ages 60 years and up

  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.

You CAN'T join if...

  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.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Washington
ID
NCT06957743
Study Type
Interventional
Participants
Expecting 375 study participants
Last Updated