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

University of Washington

Status: Not yet enrolling

Conditions: Self-Hypnosis; Mindfulness Meditation; Chronic Pain

Treatments: Behavioral: Mindfulness Meditation; Behavioral: Self-Hypnosis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06957743

STUDY00021167

R01AG079832-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 375 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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375 participants in 3 patient groups

Mindfulness Meditation

Experimental group

Description:

Participants will lie flat on their back with their eyes closed and will listen to the clinician read a standardized Mindfulness Meditation script.

Treatment:

Behavioral: Mindfulness Meditation

Self-Hypnosis

Experimental group

Description:

Participants will lie flat on their back with their eyes closed and will listen to the clinician read a standardized hypnotic script.

Treatment:

Behavioral: Self-Hypnosis

Attention Control Condition

No Intervention group

Description:

Participants in the control condition will listen to four, 20-min. excerpts from a natural history book. The sessions will be done in the same setting as the Mindfulness Meditation and Self-Hypnosis sessions; control participants will lie flat on their back and will listen to the clinician read the standardized book excerpt. This control was chosen as past research has found that individuals who listen to this standardized text report it to be a neutral, but relaxing text, and it has been used as an effective control compared with meditation conditions in previous research.