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| ID | Type | Description | Link |
|---|---|---|---|
| 2KR941702 | Other Grant/Funding Number | North Carolina Translational and Clinical Sciences Institute |
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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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The objective of this study is to determine the feasibility and acceptability of a 4-week mindfulness training program for adults with chronic pain (noncancer related). The intervention is based on the MIndfulness-based Stress Reduction Program, an 8-week mindfulness training program developed to help people manage stress-related and chronic conditions. The adapted mindfulness intervention will consist of four, weekly 1 hour and 30 minute group sessions that are modified from the original program to fit the shorter length and to directly address chronic pain management. Participants will complete pre- and post-intervention surveys and daily mindfulness practice diaries, all online. The surveys will help us determine if participants experience decreased pain interference, increased quality-of-life, and increased psychological well-being over the course of the intervention. Participants will also complete a post-intervention telephone interview to help determine satisfaction with the intervention and areas where the intervention can be improved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Training For Chronic Pain | Experimental | The intervention is adapted from the mindfulness-based stress reduction program. The adapted mindfulness training program consists of four, weekly 90 minute group sessions that focus on education on chronic pain and mindfulness, instruction and in-class mindfulness skills practice, and group discussion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Training For Chronic Pain | Behavioral | 4-week group Mindfulness training program for adults with chronic pain |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Study Retention | Proportion of participants enrolled who completed the study | 4 weeks |
| Feasibility - Session Attendance | Average sessions attended (proportion) | 4 weeks (intervention weeks 1-4) |
| Credibility and Expectancy Questionnaire Scores | Credibility and Expectancy Questionnaire. Each item is scored separately and rated on a scale from 1 [not at all] to 10 [very]. Scores for each item range from 1-10, with higher ratings indicating higher credibility and expectancy. | Intervention week 2 |
| Acceptability - Intervention Satisfaction | Question assessing participants satisfaction with the intervention | 4 weeks (within one week post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Scores | Pain intensity rating: 1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with pain intensity rated on 0-10 scale with lower values indicating less pain, or better outcome. | Baseline and 4 weeks (pre to post-intervention) |
| Pain Interference Scores |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale Scores | Perceived Stress Scale - 4 item version. Possible scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome. | Baseline and 4 weeks (pre to post-intervention) |
| Positive Affect and Well-being Scores |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carrie Brintz, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38434590 | Derived | Brintz CE, Polser G, Coronado RA, French B, Faurot KR, Gaylord SA. Are Formal and Informal Home Mindfulness Practice Quantities Associated With Outcomes? Results From a Pilot Study of a Four-Week Mindfulness Intervention for Chronic Pain Management. Glob Adv Integr Med Health. 2024 Feb 29;13:27536130241236775. doi: 10.1177/27536130241236775. eCollection 2024 Jan-Dec. |
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Recruitment Dates: April 2018 to September 2018 Recruitment Setting: Medical clinics; University/Medical center campus and email listserve
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Training | 4-week mindfulness skills group for adults with chronic pain |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline analysis includes all 23 participants who enrolled and completed the baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Training | 4-week mindfulness skills group for adults with chronic pain |
| 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 | Mean |
| 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 | Feasibility - Study Retention | Proportion of participants enrolled who completed the study | All participants who enrolled and completed the baseline assessment | Posted | Mean | 95% Confidence Interval | Proportion of participants | 4 weeks |
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4 weeks (session 1 through session 4)
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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 | Mindfulness Training | 4-week mindfulness skills group for adults with chronic pain |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Distress due to potential for dissociating | Psychiatric disorders | Non-systematic Assessment | Participant felt like might dissociate during mindfulness meditation practice (had past history of a dissociative disorder). Resulted in distress, which was resolved during the course of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carrie Brintz | University of North Carolina School of Medicine | 919-445-6109 | carrie_brintz@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2018 | May 15, 2019 | Prot_SAP_000.pdf |
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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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Single-group, mixed methods repeated measures design (pre and post assessments)
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Pain Interference short-form 6b, Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates lower pain interference, or a better outcome. |
| Baseline and 4 weeks (pre to post-intervention) |
| Physical Functioning Scores | Physical functioning short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A higher score indicates higher physical functioning, or a better outcome. | Baseline and 4 weeks (pre to post-intervention) |
| Depression Short-Form 4a Scores | Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates less depression, a better outcome. | Baseline and 4 weeks (pre to post-intervention) |
| Anxiety Short-Form 4a Scores | Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent lower anxiety, a better outcome. | Baseline and 4 weeks (pre to post-intervention) |
| Sleep Disturbance Short-Form 4a Scores | Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent less sleep disturbance, a better outcome. | Baseline and 4 weeks (pre to post-intervention) |
Positive Affect and Well-being Scale - 9 items. This scale comes from the Neurological Quality of Life Measurement System (Neuro QOL). Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Higher scores indicate greater positive affect and well-being, a better outcome.
| Baseline and 4 weeks (pre to post-intervention) |
| Pain Catastrophizing Scale Scores | Pain Catastrophizing Scale. Scores range from 0-52, with higher scores indicating more pain catastrophizing, or worse outcome. | Baseline and 4 weeks (pre to post-intervention) |
| Chronic Pain Acceptance Scores | Chronic Pain Acceptance Questionnaire-Revised. Scores range from 0-120 with higher scores representing higher chronic pain acceptance, a better outcome. | Baseline and 4 weeks (pre to post-intervention) |
| Trait Mindfulness Scores | Freiburg Mindfulness Inventory. Possible scores range from 14 to 52, with higher scores indicating greater mindfulness, a better outcome. | Baseline and 4 weeks (pre to post-intervention) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Years with chronic pain | Mean | Standard Deviation | years |
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| Education | Count of Participants | Participants |
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| Yearly Household Income | Count of Participants | Participants |
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| Source/location of pain | Count of Participants | Participants |
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| Primary | Feasibility - Session Attendance | Average sessions attended (proportion) | Posted | Mean | 95% Confidence Interval | Proportion of sessions | 4 weeks (intervention weeks 1-4) |
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| Primary | Credibility and Expectancy Questionnaire Scores | Credibility and Expectancy Questionnaire. Each item is scored separately and rated on a scale from 1 [not at all] to 10 [very]. Scores for each item range from 1-10, with higher ratings indicating higher credibility and expectancy. | Participants who completed the measure after session 2 (week 2) | Posted | Mean | Standard Deviation | units on a scale | Intervention week 2 |
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| Primary | Acceptability - Intervention Satisfaction | Question assessing participants satisfaction with the intervention | Participants who completed the post-assessment | Posted | Count of Participants | Participants | 4 weeks (within one week post-intervention) |
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| Secondary | Pain Intensity Scores | Pain intensity rating: 1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with pain intensity rated on 0-10 scale with lower values indicating less pain, or better outcome. | Participants who completed baseline and post-assessments | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks (pre to post-intervention) |
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| Secondary | Pain Interference Scores | Pain Interference short-form 6b, Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates lower pain interference, or a better outcome. | Participants who completed baseline and post assessments | Posted | Mean | Standard Deviation | T-score | Baseline and 4 weeks (pre to post-intervention) |
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| Secondary | Physical Functioning Scores | Physical functioning short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A higher score indicates higher physical functioning, or a better outcome. | Participants who completed baseline and post assessments | Posted | Mean | Standard Deviation | T-score | Baseline and 4 weeks (pre to post-intervention) |
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| Secondary | Depression Short-Form 4a Scores | Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates less depression, a better outcome. | Participants who completed baseline and post assessments | Posted | Mean | Standard Deviation | T-score | Baseline and 4 weeks (pre to post-intervention) |
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| Secondary | Anxiety Short-Form 4a Scores | Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent lower anxiety, a better outcome. | Participants who completed baseline and post assessments | Posted | Mean | Standard Deviation | T-score | Baseline and 4 weeks (pre to post-intervention) |
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| Secondary | Sleep Disturbance Short-Form 4a Scores | Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent less sleep disturbance, a better outcome. | Participants who completed baseline and post-assessment | Posted | Mean | Standard Deviation | T-score | Baseline and 4 weeks (pre to post-intervention) |
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| Other Pre-specified | Perceived Stress Scale Scores | Perceived Stress Scale - 4 item version. Possible scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome. | Participants who completed baseline and post assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4 weeks (pre to post-intervention) |
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| Other Pre-specified | Positive Affect and Well-being Scores | Positive Affect and Well-being Scale - 9 items. This scale comes from the Neurological Quality of Life Measurement System (Neuro QOL). Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Higher scores indicate greater positive affect and well-being, a better outcome. | Participants who completed baseline and post assessments | Posted | Mean | Standard Deviation | T-score | Baseline and 4 weeks (pre to post-intervention) |
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| Other Pre-specified | Pain Catastrophizing Scale Scores | Pain Catastrophizing Scale. Scores range from 0-52, with higher scores indicating more pain catastrophizing, or worse outcome. | Participants who completed baseline and post assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4 weeks (pre to post-intervention) |
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| Other Pre-specified | Chronic Pain Acceptance Scores | Chronic Pain Acceptance Questionnaire-Revised. Scores range from 0-120 with higher scores representing higher chronic pain acceptance, a better outcome. | Participants who completed baseline and post assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4 weeks (pre to post-intervention) |
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| Other Pre-specified | Trait Mindfulness Scores | Freiburg Mindfulness Inventory. Possible scores range from 14 to 52, with higher scores indicating greater mindfulness, a better outcome. | Participants who completed baseline and post assessments | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4 weeks (pre to post-intervention) |
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| 0 |
| 23 |
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| 23 |
| 1 |
| 23 |
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| How important we make this available to others |
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| Believe program would decrease other problems? |
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| Neutral |
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| Slightly satisfied |
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| Moderately satisfied |
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| Very satisfied |
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