Mindfulness Intervention for Individuals With HIV and Chronic Pain

Browse trials for

• Chronic Pain 2,930
• HIV Infections 4,258

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Lead sponsor

Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.

Study arms

• Experimental
  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.

  Behavioral: ONE Mindfulness-Oriented Recovery Enhancement

• No intervention
  Treatment As Usual

  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

• BehavioralONE 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 outcomes

1. Recruitment Feasibility

   Examine recruitment rates during the 4 months of recruitment.

   Time frame: 4 months

2. Intervention Adherence

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

   Time frame: 2 Hours

3. Treatment Acceptability

   Treatment acceptability will be assessed with a 12-item adaptation of the Treatment Framework of Acceptability questionnaire. Higher scores reflect greater acceptability.

   Time frame: Completed immediately after the 2-hour ONE MORE training

Secondary outcomes

1. Global Impression of Change

   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.

   Time frame: Completed at 2- and 4-week follow-ups

Other outcomes

1. Acute Pain Unpleasantness

   Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.

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

2. Acute Pain Intensity

   Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity.

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

3. Daily Pain Intensity

   Change in daily pain intensity from from the first post-intervention day through the 4-week follow-up will be assessed with the pain intensity item from the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain intensity.

   Time frame: Daily for 4 weeks

4. Daily Pain Interference

   Change in daily pain interference from from the first post-intervention day through the 4-week follow-up will be assessed with the two pain interference items from the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain interference.

   Time frame: Daily for 4 weeks

5. Chronic Pain

   Change in chronic pain from baseline through 4-week follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater chronic pain.

   Time frame: Baseline, 2 weeks post-treatment, 4 week post-treatment]

6. Sleep

   Change in sleep from baseline through 4-week follow-up will be assessed with the PROMIS Sleep Disturbance Short Form. Scores range from 6 to 30, with higher scores reflecting worse sleep.

   Time frame: Baseline, 2 weeks post-treatment, 4 week post-treatment]

7. Pain Catastrophizing

   Change in pain catastrophizing from baseline through 4-week follow-up will be assessed with the Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores reflecting greater pain catastrophizing.

   Time frame: Baseline, 2 weeks post-treatment, 4 week post-treatment

8. Depression

   Change in depression from baseline through 6-week follow-up will be assessed with the Patient Health Questionnaire-2. Scores range from 0 to 6, with higher scores reflecting greater depression.

   Time frame: Baseline, 2 weeks post-treatment, 4 week post-treatment]

9. Anxiety

   Change in anxiety from baseline through 4-week follow-up will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety.

   Time frame: Baseline, 2 weeks post-treatment, 4 week post-treatment

10. Prescription Pain Medication Use

    Change in prescription pain medication misuse from baseline through 4-week follow-up will be assessed with the PROMIS Prescription Pain Medication Misuse Short Form. Scores range from 7 to 35, with higher scores reflecting greater medication misuse.

    Time frame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment

11. Substance Use

    Change in substance misuse from baseline through 4-week follow-up will be assessed with the Severity of Substance Use Short Form 7a. Scores range from 7 to 35, with higher scores reflecting greater substance use

    Time frame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment

12. Alcohol Use

    Change in alcohol use from baseline through 4-week follow-up will be assessed with the PROMIS v1.0 Alcohol Use - Short Form 7a. Scores range from 7 to 35, with higher scores reflecting greater alcohol use

    Time frame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment

13. Nicotine Use

    Change in nicotine use from baseline through 4-week follow-up will be assessed with the Smoking: Nicotine Dependence for All Smokers - Short Form 4a. Scores range from 4 to 20, with higher scores reflecting greater nicotine use

    Time frame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment

14. Mindful Pain Management Mindful Pain Management

    Change in the use of mindfulness for pain management from baseline through 4-week follow-up will be assessed with the Mindful Reappraisal of Pain Scale. Scores range from 0 to 54, with higher scores reflecting greater mindful pain management.

    Time frame: Baseline, 2 weeks post-treatment, 4 week post-treatment

15. Self-Transcendent Experiences Self-Transcendent Experiences

    Change in the the frequency of self-transcendent experiences from baseline through 4-week follow-up will be assessed with the Nondual Awareness Dimensional Assessment. Scores range from 0 to 5, with higher scores reflecting more frequent self-transcendent experiences.

    Time frame: Baseline, 2 weeks post-treatment, 4 week post-treatment

16. Self Transcendent State

    Change in self-transcendent state from immediately before treatment to immediately after treatment will be assessed with the Nondual Awareness Dimensional Assessment- State Version. Scores range from 0 to 10, with higher scores reflecting deeper states of self-transcendence.

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

17. Trait-Like Decentering

    Change in meta-awareness, non-reactivity, and acceptance from baseline through 4-week follow-up will be assessed with the Metacognitive Processes of Decentering Scale. Scores range from 15 to 75, with higher scores reflecting greater emotional balance

    Time frame: Baseline, 2-weeks post-treatment, 4 weeks post-treatment

18. State-Like Decentering

    Change in decentering from immediately before treatment to immediately after treatment (i.e., 2 hours later) will be assessed with the Metacognitive Processes of Decentering Scale. Scores range from 0 to 10, with higher scores reflecting greater de-centering

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

19. Savoring Beliefs

    Change in individuals' perceptions of their ability to derive pleasure through anticipating upcoming positive events, savoring positive moments, and reminiscing about past positive experiences were measured from baseline through 4-week follow-up will be assessed with the Savoring Beliefs Inventory. Scores range from 0 to 4, with higher scores reflecting stronger enjoyment of life.

    Time frame: Baseline, 2 weeks post-treatment, 4 week post-treatment

Individual participant data

Plan to share: No