Mindfulness Intervention for Individuals With HIV and Chronic Pain

Not Applicable

Recruiting

• Conditions: Chronic Pain; HIV Infections
• Interventions: Behavioral: ONE Mindfulness-Oriented Recovery Enhancement

• Registration Number: NCT06481501
• Lead Sponsor: Florida State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-24
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Status Verified: 2024-07
• Study First Posted: 2024-07-01
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-06-24
• Study Completion: 2025-07-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONE Mindfulness-Oriented Recovery Enhancement	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Global Impression of Change	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.

Trial Locations

Locations (1)

Brain Science and Symptom Management Center; 🇺🇸 Tallahassee, Florida, United States