Recruiting

Mindfulness-Meditation, Therapeutic Hypnosis, Story Listening

Sponsor:

University of Washington

Code:

NCT06957743

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Mindfulness Meditation

Therapeutic Hypnosis

Story Listening

Study Details

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 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

Conditions

Chronic Pain

Study ID

NCT06957743

Start date

Mar 4, 2026

Status verified date

Jun, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Enrollment

375 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mindfulness Meditation

Participants will lie flat on their back with their eyes closed 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.

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.

Interventions

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.

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).

Story Listening

Participants will lie flat on their back and will listen to a recorded story from a natural history book.

Primary outcome measure

  • Change in average chronic pain intensity in past 24 hours [ 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 ]

Central Contacts and Locations

Central contacts

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98104

Contacts

More Information

Sponsor

University of Washington

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Chronic Pain
  • Mindfulness Meditation
  • Therapeutic Hypnosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-06-04.