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| ID | Type | Description | Link |
|---|---|---|---|
| A532007 | Other Identifier | UW Madison | |
| SMPH/FAMILY MED/RES GRANTS | Other Identifier | UW Madison | |
| Protocol Version 6/25/2018 | Other Identifier | UW Madison |
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This pilot randomized clinical trial (RCT) will randomize adults with chronic pain to one, 20-minute session of either: Brief Mindfulness-Based Intervention (BMBI) mindfulness training or nutrition education (Control). Following the session, participants will be encouraged to practice a technique associated with their intervention (i.e., practicing mindfulness technique in BMBI, preparing healthy meals in Control) 20 minutes/day for one week at home. Quantitative sensory testing (with cold pressor and algometer) will be conducted before and after the session, and self-reported outcome assessments will be conducted before and after the session and at 1-week follow-up.
Participants. To gather pilot data on the effects of BMBI, the investigators will aim to enroll up to 60 participants (up to 30 in each condition). Participants will be adults with chronic non-cancer pain (daily pain for at least 3 months).
Outcomes. Outcome measures were selected based on existing recommendations, including IMMPACT guidelines, for efficacy trials in chronic pain.
Procedure. Participants will be recruited primarily via flyers and postings in newspapers and on the Internet. Prospective participants will be screened by phone (about 30 minutes). Provisionally eligible participants will be asked to attend a 1-hour appointment, which will begin with informed consent procedures (5-10 minutes) and a pre-intervention assessment (about 20 minutes; includes demographics questionnaire, self-report outcome measures, and quantitative sensory testing).
Eligible participants will be randomized to a condition, complete a 20-minute session of either BMBI or Control, and undergo a postintervention assessment (about 10 minutes; includes self-report outcome measures and quantitative sensory testing). Following the assessment, participants will be encouraged to practice the technique associated with their intervention (i.e., practicing mindfulness technique in BMBI, preparing healthy meals in Control) 20 minutes/day for 1 week at home and to track their practice and opioid use during the follow-up period; the follow-up assessments will be conducted over the phone by a research assistant and include the self-report outcome measures (no quantitative sensory testing). All study procedures are anticipated to last 2 hours and 30 minutes (30 minutes for screening, 1 hour for in-person appointment, and 30 minutes for each follow-up assessment).
Interventions: The BMBI is be based on a BMBI which demonstrated analgesic effects in a previous study. Relative to full-length interventions, the investigators will employ a brief intervention (i.e., one, 20-minute session) that could be delivered in routine clinical care, e.g., in primary care, and that could overcome cost and time/effort barriers associated with longer treatments. The 20-minute BMBI session will include education on the foundational concepts of mindfulness and its relevance to chronic pain (5 minutes) and a guided mindfulness practice involving focused attention on the breath and monitoring of thoughts, feelings, and body sensations (15 minutes). BMBI participants will be encouraged to practice the taught mindfulness technique at home at least 20 minutes/day for 1 week (a handout and link to an online guided mindfulness practice will be provided).
The Control intervention will involve nutrition education, adapted from an existing manual of cognitive-behavioral therapy for opioid-treated chronic pain. Control intervention protocol will match the BMBI in terms of time / structure to control for the non-specific, non-mindfulness effects of BMBI. The 20-minute Control session will include education on the relationship between diet and pain (10 minutes) and recommendations for a healthy diet (10 minutes). Control participants will be encouraged to prepare healthy meals at home at least 20 minutes/day for 1 week (a handout and link to online resources will be provided).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Mindfulness-Based Intervention | Experimental | Those assigned to the Brief Mindfulness-Based Intervention (BMBI) Arm will receive BMBI. |
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| Control/Nutrition Education | Active Comparator | Those assigned to the Control/Nutrition Education Arm will receive the nutrition education intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Mindfulness-Based Intervention (BMBI) | Behavioral | The BMBI is be based on a BMBI which demonstrated analgesic effects in a previous study. Relative to full-length interventions, we will employ a brief intervention; the 20-minute BMBI session will include education on the foundational concepts of mindfulness and its relevance to chronic pain (5 minutes) and a guided mindfulness practice involving focused attention on the breath and monitoring of thoughts, feelings, and body sensations (15 minutes). BMBI participants will be encouraged to practice the taught mindfulness technique at home at least 20 minutes/day for 1 week (a handout and link to an online guided mindfulness practice will be provided). |
| Measure | Description | Time Frame |
|---|---|---|
| Cold pressor testing | Cold pressor testing will be used to characterize pain processing (e.g., pain threshold, pain tolerance, pain severity). In the cold pressor test, a participant is asked to place his or her hand and forearm in an ice bath until the pain is too great to remain in the water. Consistent with past research, a 15 liter refrigerated circulator (Polyscience MX15R-30-A11B) with water temperature set as low as 1°C will be used in the present study. | 1 hour |
| Pressure algometer testing | Pressure algometer testing will be used to characterize pain processing (e.g., pain threshold, pain tolerance, pain severity). In the pressure algometer test, the algometer is used to apply pressure to the skin until the pain can no longer be tolerated. In the current study, we will utilize a device widely used in alogmeter pain research (Wagnder Force One Alogmeter FIPX). | 1 hour |
| Brief Pain Inventory | Measures: 1) pain severity= mean of items 3-6 (ranges from 0-10 with higher scores indicating greater pain severity), and 2) pain interference= mean of items 9A-9G (ranges from 0-10 with higher scores indicating greater pain interference). | 4 weeks |
| Hospital Anxiety and Depression Scale | Measures: 1) Anxiety (sum of 7 items; ranges from 0-21, with higher scores indicating greater anxiety), and 2) Depression (sum of 7 items; ranges from 0-21, with higher scores indicating greater depressive symptoms). | 4 weeks |
| Mindful Attention Awareness Scale | Measures mindfulness; mean of 15 items (ranges from 1 to 6, with higher scores indicating greater levels of mindfulness) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53715 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Control/Nutrition Education | Behavioral | The Control intervention will involve nutrition education, adapted from an existing manual of cognitive-behavioral therapy for opioid-treated chronic pain. Control intervention protocol will match the BMBI in terms of time / structure to control for the non-specific, non-mindfulness effects of BMBI. The 20-minute Control session will include education on the relationship between diet and pain (10 minutes) and recommendations for a healthy diet (10 minutes). Control participants will be encouraged to prepare healthy meals at home at least 20 minutes/day for 1 week (a handout and link to online resources will be provided). |
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| Schwartz Outcome Scale |
Measures general well-being; sum of 10 items (ranges from 0 to 60, with higher scores indicating greater well-being) |
| 4 weeks |
| Toronto Mindfulness Scale-Decentering Subscale | Measures decentering; sum of 7 items (higher scores indicate greater levels of decentering) | 1 hour |
| Opioid Compliance Checklist | Measure misuse of opioid medications (scores range from 0 to 12, with higher scoring indicating greater misuse) | 4 weeks |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |