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Mindfulness Intervention for Individuals With HIV and Chronic Pain

Mindfulness Intervention for Individuals With HIV and Chronic Pain

Status
Suspended
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06481501
Enrollment
40
Registered
2024-07-01
Start date
2024-06-24
Completion date
2027-07-25
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, HIV Infections

Brief summary

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.

Interventions

BEHAVIORALONE 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.

Sponsors

Florida State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment Feasibility4 monthsExamine recruitment rates during the 4 months of recruitment.
Intervention Adherence2 HoursExamine the percentage of participants completing their 2-hour intervention session.
Treatment AcceptabilityCompleted immediately after the 2-hour ONE MORE trainingTreatment acceptability will be assessed with a 12-item adaptation of the Treatment Framework of Acceptability questionnaire. Higher scores reflect greater acceptability.

Secondary

MeasureTime frameDescription
Global Impression of ChangeCompleted at 2- and 4-week follow-upsTreatment 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026