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Behavioral Intervention
Mindfulness Intervention for HIV and Chronic Pain
N/A
Recruiting
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of chronic pain
18 years of age or older
Must not have
Being unable to follow tasks due to pain level
Not having HIV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how a shorter version of a specific type of therapy called Mindfulness-Oriented Recovery Enhancement can help people with HIV and chronic pain.
Who is the study for?
This trial is for individuals living with HIV who also experience chronic pain. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and be able to commit to the study's requirements.
What is being tested?
The trial is testing a program called ONE Mindfulness-Oriented Recovery Enhancement (ONE MORE). It involves a 2-hour training session designed to help manage HIV-related chronic pain through mindfulness techniques.
What are the potential side effects?
Since this intervention involves mindfulness training, there may not be direct physical side effects like those associated with medication. However, emotional discomfort or psychological distress could potentially arise during mindfulness practice.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with chronic pain.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My pain prevents me from completing tasks.
Select...
I do not have HIV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Intervention Adherence
Recruitment Feasibility
Treatment Acceptability
Secondary study objectives
Global Impression of Change
Other study objectives
Acute Pain Intensity
Acute Pain Unpleasantness
Alcohol Use
+16 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ONE Mindfulness-Oriented Recovery EnhancementExperimental Treatment1 Intervention
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.
Group II: Treatment As UsualActive Control1 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.
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Who is running the clinical trial?
Florida State UniversityLead Sponsor
224 Previous Clinical Trials
36,695 Total Patients Enrolled