Clinical trial NCT06481501: Mindfulness Intervention for Individuals With HIV and Chronic Pain
Official title: Mindfulness Intervention for Individuals With HIV and Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
HIV Infections
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: 4 months
measure: Intervention Adherence
timeFrame: 2 Hours
measure: Treatment Acceptability
timeFrame: Completed immediately after the 2-hour ONE MORE training
Secondary outcomes:
measure: Global Impression of Change
timeFrame: Completed at 2- and 4-week follow-ups
Other outcomes:
measure: Acute Pain Unpleasantness
timeFrame: Will be completed immediately before and after the 2-hour intervention session
measure: Acute Pain Intensity
timeFrame: Will be completed immediately before and after the 2-hour intervention session
measure: Daily Pain Intensity
timeFrame: Daily for 4 weeks
measure: Daily Pain Interference
timeFrame: Daily for 4 weeks
measure: Chronic Pain
timeFrame: Baseline, 2 weeks post-treatment, 4 week post-treatment]
measure: Sleep
timeFrame: Baseline, 2 weeks post-treatment, 4 week post-treatment]
measure: Pain Catastrophizing
timeFrame: Baseline, 2 weeks post-treatment, 4 week post-treatment
measure: Depression
timeFrame: Baseline, 2 weeks post-treatment, 4 week post-treatment]
measure: Anxiety
timeFrame: Baseline, 2 weeks post-treatment, 4 week post-treatment
measure: Prescription Pain Medication Use
timeFrame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment
measure: Substance Use
timeFrame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment
measure: Alcohol Use
timeFrame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment
measure: Nicotine Use
timeFrame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment
measure: Mindful Pain Management Mindful Pain Management
timeFrame: Baseline, 2 weeks post-treatment, 4 week post-treatment
measure: Self-Transcendent Experiences Self-Transcendent Experiences
timeFrame: Baseline, 2 weeks post-treatment, 4 week post-treatment
measure: Self Transcendent State
timeFrame: Will be completed immediately before and after the 2-hour intervention session
measure: Trait-Like Decentering
timeFrame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment
measure: State-Like Decentering
timeFrame: Will be completed immediately before and after the 2-hour intervention session
measure: Savoring Beliefs
timeFrame: Baseline, 2 weeks post-treatment, 4 week post-treatment
Locations:
city: Tallahassee
country: United States
facility: Brain Science and Symptom Management Center
state: Florida
Study officials:
References: