Mindfulness Intervention for Individuals With HIV and Chronic Pain

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: Suspended
• Conditions: HIV Infections; Chronic Pain
• Intervention / Treatment: Behavioral: ONE Mindfulness-Oriented Recovery Enhancement

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Intervention Adherence	Examine the percentage of participants completing their 2-hour intervention session.	2 Hours
Recruitment Feasibility	Examine recruitment rates during the 4 months of recruitment.	4 months
Treatment Acceptability	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

Outcome Measure	Measure Description	Time Frame
Global Impression of Change	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

Outcome Measure	Measure Description	Time Frame
Acute Pain Unpleasantness	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): July 25, 2026

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID 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