Mindfulness Intervention for Individuals With HIV and Chronic Pain

July 10, 2026 updated by: Adam Hanley, Florida State University
This project is a single-site, two-arm, randomized controlled pilot study examining the impact of a 2-hour version of Mindfulness-Oriented Recovery Enhancement (ONE MORE) training for individuals with HIV and chronic pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32310
        • Brain Science and Symptom Management Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of chronic pain
  • Be HIV+
  • 18 years of age or older
  • Fluent English speaker
  • Will commit to try no other new treatments during study duration

Exclusion Criteria:

  • Not having HIV
  • Being unable to follow tasks due to pain level
  • Prior mindfulness training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ONE Mindfulness-Oriented Recovery Enhancement
One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into four, 30-minute segments. In the first segment, participants will be introduced to mindfulness and guided though a body scan practice, which directs participants to systematically shift attention from one part of the body to the next. Mindful pain management will be the focus of the second segment and participants will be guided through a mindfulness of pain practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The third segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, and the fourth segment will focus on increasing the positive emotions that can attenuate pain with mindful savoring.
Behavioral: ONE Mindfulness-Oriented Recovery Enhancement
One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into four, 30-minute segments. In the first segment, participants will be introduced to mindfulness and guided though a body scan practice, which directs participants to systematically shift attention from one part of the body to the next. Mindful pain management will be the focus of the second segment and participants will be guided through a mindfulness of pain practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The third segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, and the fourth segment will focus on increasing the positive emotions that can attenuate pain with mindful savoring.
No Intervention: Treatment As Usual
In the Treatment as Usual (TAU) condition, participants will complete all study assessments (pre-treatment, post-treatment, 2-week, 4-week) without receiving any ONE MORE training. During their study involvement, TAU participants will be encouraged to continue any previously initiated treatment but discouraged from beginning any new form of treatment. Those in the TAU condition will not be sent any training materials.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intervention Adherence
Time Frame: 2 Hours
Examine the percentage of participants completing their 2-hour intervention session.
2 Hours
Recruitment Feasibility
Time Frame: 4 months
Examine recruitment rates during the 4 months of recruitment.
4 months
Treatment Acceptability
Time Frame: Completed immediately after the 2-hour ONE MORE training
Treatment acceptability will be assessed with a 12-item adaptation of the Treatment Framework of Acceptability questionnaire. Higher scores reflect greater acceptability.
Completed immediately after the 2-hour ONE MORE training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Global Impression of Change
Time Frame: Completed at 2- and 4-week follow-ups
Treatment related improvement will be assessed with the Patient Global Impression of Change scale. Scores range from 0 to 7, with higher scores reflecting greater treatment related improvement.
Completed at 2- and 4-week follow-ups

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute Pain Unpleasantness
Time Frame: Will be completed immediately before and after the 2-hour intervention session
Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.
Will be completed immediately before and after the 2-hour intervention session
Acute Pain Intensity
Time Frame: Will be completed immediately before and after the 2-hour intervention session
Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity.
Will be completed immediately before and after the 2-hour intervention session
Daily Pain Intensity
Time Frame: Daily for 4 weeks
Change in daily pain intensity from from the first post-intervention day through the 4-week follow-up will be assessed with the pain intensity item from the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain intensity.
Daily for 4 weeks
Daily Pain Interference
Time Frame: Daily for 4 weeks
Change in daily pain interference from from the first post-intervention day through the 4-week follow-up will be assessed with the two pain interference items from the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain interference.
Daily for 4 weeks
Chronic Pain
Time Frame: Baseline, 2 weeks post-treatment, 4 week post-treatment]
Change in chronic pain from baseline through 4-week follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater chronic pain.
Baseline, 2 weeks post-treatment, 4 week post-treatment]
Sleep
Time Frame: Baseline, 2 weeks post-treatment, 4 week post-treatment]
Change in sleep from baseline through 4-week follow-up will be assessed with the PROMIS Sleep Disturbance Short Form. Scores range from 6 to 30, with higher scores reflecting worse sleep.
Baseline, 2 weeks post-treatment, 4 week post-treatment]
Pain Catastrophizing
Time Frame: Baseline, 2 weeks post-treatment, 4 week post-treatment
Change in pain catastrophizing from baseline through 4-week follow-up will be assessed with the Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores reflecting greater pain catastrophizing.
Baseline, 2 weeks post-treatment, 4 week post-treatment
Depression
Time Frame: Baseline, 2 weeks post-treatment, 4 week post-treatment]
Change in depression from baseline through 6-week follow-up will be assessed with the Patient Health Questionnaire-2. Scores range from 0 to 6, with higher scores reflecting greater depression.
Baseline, 2 weeks post-treatment, 4 week post-treatment]
Anxiety
Time Frame: Baseline, 2 weeks post-treatment, 4 week post-treatment
Change in anxiety from baseline through 4-week follow-up will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety.
Baseline, 2 weeks post-treatment, 4 week post-treatment
Prescription Pain Medication Use
Time Frame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment
Change in prescription pain medication misuse from baseline through 4-week follow-up will be assessed with the PROMIS Prescription Pain Medication Misuse Short Form. Scores range from 7 to 35, with higher scores reflecting greater medication misuse.
Baseline, 2-weeks post-treatment, 4 weeks post-treatment
Substance Use
Time Frame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment
Change in substance misuse from baseline through 4-week follow-up will be assessed with the Severity of Substance Use Short Form 7a. Scores range from 7 to 35, with higher scores reflecting greater substance use
Baseline, 2-weeks post-treatment, 4 weeks post-treatment
Alcohol Use
Time Frame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment
Change in alcohol use from baseline through 4-week follow-up will be assessed with the PROMIS v1.0 Alcohol Use - Short Form 7a. Scores range from 7 to 35, with higher scores reflecting greater alcohol use
Baseline, 2-weeks post-treatment, 4 weeks post-treatment
Nicotine Use
Time Frame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment
Change in nicotine use from baseline through 4-week follow-up will be assessed with the Smoking: Nicotine Dependence for All Smokers - Short Form 4a. Scores range from 4 to 20, with higher scores reflecting greater nicotine use
Baseline, 2-weeks post-treatment, 4 weeks post-treatment
Mindful Pain Management Mindful Pain Management
Time Frame: Baseline, 2 weeks post-treatment, 4 week post-treatment
Change in the use of mindfulness for pain management from baseline through 4-week follow-up will be assessed with the Mindful Reappraisal of Pain Scale. Scores range from 0 to 54, with higher scores reflecting greater mindful pain management.
Baseline, 2 weeks post-treatment, 4 week post-treatment
Self-Transcendent Experiences Self-Transcendent Experiences
Time Frame: Baseline, 2 weeks post-treatment, 4 week post-treatment
Change in the the frequency of self-transcendent experiences from baseline through 4-week follow-up will be assessed with the Nondual Awareness Dimensional Assessment. Scores range from 0 to 5, with higher scores reflecting more frequent self-transcendent experiences.
Baseline, 2 weeks post-treatment, 4 week post-treatment
Self Transcendent State
Time Frame: Will be completed immediately before and after the 2-hour intervention session
Change in self-transcendent state from immediately before treatment to immediately after treatment will be assessed with the Nondual Awareness Dimensional Assessment- State Version. Scores range from 0 to 10, with higher scores reflecting deeper states of self-transcendence.
Will be completed immediately before and after the 2-hour intervention session
Trait-Like Decentering
Time Frame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment
Change in meta-awareness, non-reactivity, and acceptance from baseline through 4-week follow-up will be assessed with the Metacognitive Processes of Decentering Scale. Scores range from 15 to 75, with higher scores reflecting greater emotional balance
Baseline, 2-weeks post-treatment, 4 weeks post-treatment
State-Like Decentering
Time Frame: Will be completed immediately before and after the 2-hour intervention session
Change in decentering from immediately before treatment to immediately after treatment (i.e., 2 hours later) will be assessed with the Metacognitive Processes of Decentering Scale. Scores range from 0 to 10, with higher scores reflecting greater de-centering
Will be completed immediately before and after the 2-hour intervention session
Savoring Beliefs
Time Frame: Baseline, 2 weeks post-treatment, 4 week post-treatment
Change in individuals' perceptions of their ability to derive pleasure through anticipating upcoming positive events, savoring positive moments, and reminiscing about past positive experiences were measured from baseline through 4-week follow-up will be assessed with the Savoring Beliefs Inventory. Scores range from 0 to 4, with higher scores reflecting stronger enjoyment of life.
Baseline, 2 weeks post-treatment, 4 week post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00005157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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