Mindfulness Intervention for Individuals With HIV and Chronic Pain

NCT06481501 | Suspended

• 1 other identifier: STUDY00005157
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; HIV Infections

Outcome Measures

Primary Outcomes (3)

• Recruitment Feasibility

  Examine recruitment rates during the 4 months of recruitment.

  4 months

• Intervention Adherence

  Examine the percentage of participants completing their 2-hour intervention session.

  2 Hours

• 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 Outcomes (1)

• Global Impression of Change

  Completed at 2- and 4-week follow-ups

Other Outcomes (19)

• Acute Pain Unpleasantness

  Will be completed immediately before and after the 2-hour intervention session

• Acute Pain Intensity

  Will be completed immediately before and after the 2-hour intervention session

• Daily Pain Intensity

  Daily for 4 weeks

Study Arms (2)

ONE Mindfulness-Oriented Recovery Enhancement

EXPERIMENTAL

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

Treatment As Usual

NO INTERVENTION

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.

Interventions

ONE Mindfulness-Oriented Recovery Enhancement BEHAVIORAL

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.

ONE Mindfulness-Oriented Recovery Enhancement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Brain Science and Symptom Management Center

Tallahassee, Florida, 32310, United States

Location

MeSH Terms

Conditions

Chronic Pain; HIV Infections

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): July 25, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)