Purpose

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. Story Listening

Condition

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mindfulness Meditation
Participants will lie flat on their back with their eyes closed and will listen to a recorded Mindfulness Meditation script.
  • 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.
Experimental
Therapeutic Hypnosis
Participants will lie flat on their back with their eyes closed and will listen to a recorded hypnotic 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).
Experimental
Story Listening
Participants will lie flat on their back with their eyes closed and will listen to a recorded story from a natural history book.
  • Behavioral: Story Listening
    Participants will lie flat on their back and will listen to a recorded story from a natural history book.

Recruiting Locations

University of Washington
Seattle, Washington 98104
Contact:
Brianna Agnew
844-481-3451
reframe-study@uw.edu

More Details

Status
Recruiting
Sponsor
University of Washington

Study Contact

Rana Salem, MA
206-543-0107
rsalem@uw.edu

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 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 listen to recordings of Mindfulness Meditation, Therapeutic Hypnosis, or a story. Participants will spend about 8 hours in this study over a 4-week period.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.