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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34AT010921 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This is a development study with clinical outcomes. The investigators aim to develop and test an 8-week MBPR (Mindfulness-Based Pain Reduction) program, which draws on intervention work and clinical experience in the investigative team to optimize a mindfulness-based intervention for individuals with chronic pain. The overall goal of this study is to ensure that the MBPR program has been carefully refined and manualized in an in-person setting before performing clinical trials comparing MBPR to MBSR (Mindfulness-Based Stress Reduction) to test whether it improves pain outcomes.
This study includes a Pain Attention Task that separates insula activation during experimental heat application between different pain attention conditions.
MBPR will be an optimized mindfulness program specifically designed for treating chronic low back pain (cLBP) that the investigators aim to develop and test in this project. 4 groups of 10 participants will receive MBPR consecutively to refine the MBPR curriculum. The format is the same as MBSR: 8 weeks of weekly 2½-hour group sessions and a daylong retreat. All sessions include training to enhance mindful interoceptive awareness through focused attention in the region of pain, the lower back.
A final group of 20 participants will be randomized to receive MBPR or MBSR. Total N=50 (40 MBPR; 10 MBSR). MBSR is a standardized and manualized 8-week program, delivered once a week in 2½-hour group sessions and a daylong retreat. It trains individuals in several mindfulness practices, e.g. focus on breath, varying degrees and directions of object orientation, open monitoring of awareness of intero- and exteroceptive stimuli and thoughts, de-reification (i.e. the notion that thoughts and perceptions are not always true to reality), and meta-awareness (i.e., awareness of thinking) in addition to focused attention. The program typically includes audio-recording and a workbook for home practice and has shown benefits in patients with cLBP.
This project also includes an ancillary brain imaging study designed to build on neuroscience reports of markedly decreased brain function and structure in the insular cortex (IC) of patients with cLBP. This project has the potential to reveal a potential central mechanism by which mind-body and acceptance-based approaches improve chronic pain conditions, e.g. cLBP. It may reveal a new paradigm for the treatment of cLBP with key importance and consequences for future behavioral intervention studies for pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 4 cohorts of 10 participants to MBPR (First 3 groups single-arm, final group of 10 randomly assigned to MBPR) |
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| Group 2 | Active Comparator | The last 20 participants will be randomly assigned to MBSR or MBPR, which will results in a control group with ~10 participants undergoing MBSR |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Pain Reduction | Behavioral | 40 participants will participate in a MBPR program. It will be an optimized mindfulness program specifically designed for treating cLBP that we will develop and test in this project. The format is the same as MBSR: 8 weeks of weekly 2½-hour group sessions and a daylong retreat. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Change in average pain intensity in past week on Numeric Rating Scale [0 to 10] will be assessed by internet-based questionnaire using REDCap negative values indicate improvement. | baseline, post 8-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference | Change in average of the scores for the 3 Pain Interference items on PROMIS-29 [5-point Likert scale from 1 "Not at all" to 5 "Very much"] average for past week will be assessed by internet-based questionnaire using REDCap [range 3 - 15, higher values more interference] negative numbers indicate improvement in pain interference | baseline, post 8-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Interoceptive Awareness | change in scores for the 8 scales of the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) [6-point 0-5 Likert scale Never to Always] will be assessed by internet-based questionnaire using REDCap. Each scale range from 0-5, total score over all 8 scales is the mean of the score of the 8 scales, also ranges 0-5. Higher values indicate higher interoceptive awareness. positive values indicate improvement. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolf E Mehling, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco; Osher Center for Intgerative Medicine | San Francisco | California | 94115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MBPR | Mindfulness-Based Pain Reduction |
| FG001 | MBSR | Mindfulness-Based Stress Reduction |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MBPR | Mindfulness-Based Pain Reduction |
| BG001 | MBSR | Mindfulness-Based Stress Reduction |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity | Change in average pain intensity in past week on Numeric Rating Scale [0 to 10] will be assessed by internet-based questionnaire using REDCap negative values indicate improvement. | Posted | Mean | Standard Deviation | score on a scale | baseline, post 8-week intervention |
|
|
6 months
minimal risk
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MBPR | Mindfulness-Based Pain Reduction | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain increase | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | increased pain after a yoga movement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wolf Mehling, MD | University of California San Francisco | 415 | 9021331 | wolf.mehling@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2022 | Apr 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2019 | Mar 12, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 12, 2021 | Mar 12, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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The intervention and MBPR manual will be refined iteratively in 4 courses with 10 participants. The last of these 4 MBPR classes will be about 10 of 20 participants randomly assigned to either participate in standard MBSR or MBPR.
The first part of the study is single-arm, the last randomized to assess acceptability of randomization.
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|
| Mindfulness Based Stress Reduction | Behavioral | 10 participants will participate in MBSR program. MBSR is a standardized and manualized 8-week program, delivered once a week in 2½-hour group sessions and a daylong retreat. It trains individuals in several mindfulness practices, e.g. focus on breath, varying degrees and directions of object orientation, open monitoring of awareness of intero- and exteroceptive stimuli and thoughts, de-reification (i.e. the notion that thoughts and perceptions are not always true to reality), and meta-awareness (i.e., awareness of thinking) in addition to focused attention.The program typically includes audio-recordings and a workbook for home practice and has shown benefits in patients with cLBP. |
|
| baseline, post 8-week intervention |
| Changes in Insula Cortex Activation/Connectivity; Awaiting Separate Analysis | using fMRI, insula cortex activation and connectivity in brain fMRI; awaiting separate analysis | baseline, post 8-week intervention. |
| BG002 |
| Total |
Total of all reporting groups |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| PEG score | Pain, Enjoyment of Life and General Activity (PEG) combining Pain Intensity and Interference, 0 - 30 higher values indicate worse pain | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
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| Secondary | Pain Interference | Change in average of the scores for the 3 Pain Interference items on PROMIS-29 [5-point Likert scale from 1 "Not at all" to 5 "Very much"] average for past week will be assessed by internet-based questionnaire using REDCap [range 3 - 15, higher values more interference] negative numbers indicate improvement in pain interference | Posted | Mean | Standard Deviation | score on a scale | baseline, post 8-week intervention |
|
|
|
| Other Pre-specified | Interoceptive Awareness | change in scores for the 8 scales of the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) [6-point 0-5 Likert scale Never to Always] will be assessed by internet-based questionnaire using REDCap. Each scale range from 0-5, total score over all 8 scales is the mean of the score of the 8 scales, also ranges 0-5. Higher values indicate higher interoceptive awareness. positive values indicate improvement. | Posted | Mean | Standard Deviation | score on a scale | baseline, post 8-week intervention |
|
|
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| Other Pre-specified | Changes in Insula Cortex Activation/Connectivity; Awaiting Separate Analysis | using fMRI, insula cortex activation and connectivity in brain fMRI; awaiting separate analysis | Not Posted | Dec 2025 | baseline, post 8-week intervention. | Participants |
| 34 |
| 0 |
| 34 |
| 1 |
| 34 |
| EG001 | MBSR | Mindfulness-Based Stress Reduction | 0 | 6 | 0 | 6 | 0 | 6 |
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| D004191 |
| Behavioral Disciplines and Activities |