Mindfulness Intervention for Individuals With HIV and Chronic Pain

Not Applicable

Recruiting

• Conditions: Chronic Pain; HIV Infections

• 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

Primary Outcome Measures

Name	Time	Method
Intervention Adherence	2 Hours	Examine the percentage of participants completing their 2-hour intervention session.
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.

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