Chronic Pain, Musculoskeletal Pain, Pain
Conditions
Brief summary
This project is a single-site, two-arm, pilot study assessing the feasibility and preliminary efficacy of a 5-minute Mindful Mapping intervention for adults with chronic musculoskeletal pain (n=60) relative to a time- and attention-matched control condition.
Detailed description
This was a two-arm (Mindful Mapping vs. Serial Sevens), remotely delivered, parallel-group, pilot RCT. All procedures were approval by the local IRB and preregistered (NCT06394765). Written informed consent was obtained from all participants prior to their inclusion in the study. Participants were randomly assigned (1:1) to either the Mindful Mapping intervention (n=30) or a control condition, Serial Sevens (n=30). Randomization was performed using a computer-generated sequence.
Interventions
BEHAVIORALMindful Mapping
Participants in the Mindful Mapping condition will receive a 5-minute, therapist-guided mindfulness intervention for chronic pain. During this training they will learn the 30-second Mindful Mapping technique, which they will be instructed to use each time they experience a painful sensation over the next 2 weeks. The Mindful Mapping technique consists of focusing on five basic characteristics (shape, weight, density, temperature, movement) of the most intense sensation in the body as it emerges in the present moment while remaining equanimous, i.e., preventing the learned reaction.
BEHAVIORALSerial Sevens
Participants in the control condition will receive a 5-minute, therapist-guided serial sevens intervention for chronic pain. During this training, participants will be instructed that each time they experience pain, they will count backwards in their heads by 7 from 100 for 30 second.
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be randomized (1:1) using a computer-generated randomization sequence created by the PI prior to the study start date.
Intervention model description
This project is a single-site, two-arm, pilot study assessing the feasibility and preliminary efficacy of a 5-minute Mindful Mapping intervention for adults with chronic musculoskeletal pain relative to a time- and attention-matched control condition.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* having a chronic pain diagnosis * being able not to commit to another (new) treatment during the course of the study * understanding English instructions fluently * Being 18 and above
Exclusion criteria
* having learned to practice mindfulness meditation any time in the past * being unable to perform most basic tasks due to pain or pain treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility | 3 months | Examine recruitment rates during the 3 months planned for recruitment. |
| Randomization Feasibility | 3 months | Examine randomization rates during the 3 months planned for recruitment. |
| Intervention Adherence | 5 minutes | Examine the percentage of participants completing their 5-minute intervention session |
| Therapeutic Skill Use Adherence | 2 weeks | Examine the frequency of therapeutic skill use during the 2-week, post-intervention, self-management period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Acceptability | Completed at 2- and 6-week follow-ups | Treatment acceptability will be assessed with the Treatment Acceptability and Preference (TAP) scale. Scores range from 0 to 4, with higher scores reflecting greater acceptability. |
| Global Impression of Change | Completed at 2- and 6-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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep | Baseline, 2 weeks post-treatment, 6 week post-treatment | Change in sleep from baseline through 6-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. |
| Pain Catastrophizing | Baseline, 2 weeks post-treatment, 6 week post-treatment | Change in pain catastrophizing from baseline through 6-week follow-up will be assessed with the Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores reflecting greater pain catastrophizing. |
| Depression | Baseline, 2 weeks post-treatment, 6 week post-treatment | 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. |
| Acute Pain Unpleasantness | Will be completed immediately before and after the 5-minute intervention session | 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. |
| Prescription Pain Medication Use | Baseline, 2 weeks post-treatment, 6 week post-treatment | Change in prescription pain medication misuse from baseline through 6-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. |
| Mindful Pain Management | Baseline, 2 weeks post-treatment, 6 week post-treatment | Change in the use of mindfulness for pain management from baseline through 6-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. |
| Anxiety | Baseline, 2 weeks post-treatment, 6 week post-treatment | Change in anxiety from baseline through 6-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. |
| Acute Pain Intensity | Will be completed immediately before and after the 5-minute intervention session | 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. |
| Daily Pain Intensity | Daily for 6 weeks | Change in daily pain intensity from from the first post-intervention day through the 6-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. |
| Daily Pain Interference | Daily for 6 weeks | Change in daily pain interference from from the first post-intervention day through the 6-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. |
| Chronic Pain | Baseline, 2 weeks post-treatment, 6 week post-treatment | Change in chronic pain from baseline through 6-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. |
| Physical Function | Baseline, 2 weeks post-treatment, 6 week post-treatment | Change in physical function from baseline through 6-week follow-up will be assessed with the PROMIS Physical Functioning Short Form. Scores range from 6 to 30, with higher scores reflecting greater physical function. |
Countries
United States
Outcome results
None listed