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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT011569 | 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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Lumbar spine pain is the leading cause of years lived with a disability and affects over 50 million individuals in the United States. Rates of spine surgeries performed to address degenerative spine conditions have increased markedly. A subset of patients experience poor pain, functional, or quality of life outcomes after surgery.
This study will adapt and evaluate the feasibility and potential benefits of both a one-on-one and a group-delivered, face-to-face telehealth, mindfulness intervention for patients recovering from lumbar spine surgery. The goals of the intervention are to improve short and long-term pain management, reduce the need for long-term pain medications, and improve physical and psychological well-being after surgery. The study will result in a refined intervention manual based on feasibility, participant exit interviews and satisfaction surveys which will be piloted in a future randomized controlled trial.
We will conduct a two-arm, nonrandomized, mixed-methods trial to refine a telehealth mindfulness-based intervention (MBI) for patients recovering from spine surgery. The procedures will be as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual telehealth mindfulness | Experimental | Telehealth mindfulness sessions delivered one-on-one with mindfulness therapist |
|
| Group Telehealth Mindfulness | Experimental | Telehealth mindfulness sessions delivered in a small-group format with mindfulness therapist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual telehealth mindfulness | Behavioral | Participants who enroll and complete lumbar spine surgery will participate in a one-on-one telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 75 minutes each (except the first session which lasts 90 minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Study Retention | Percentage of participants enrolled who complete the study | 3 months following lumbar spine surgery |
| Feasibility - Session Attendance | Percent of sessions attended out of 8 | 3 months following lumbar spine surgery |
| Acceptability - Satisfaction With Intervention | Nine items assessing satisfaction with the postsurgical telehealth mindfulness intervention (sum of item scores; higher scores indicate higher satisfaction; scores can range from 7 to 55) | 3 months following lumbar spine surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Bothersomeness | One item assessing how bothersome pain has been in the past 7 days from not at all = 0 to extremely = 4. A higher scores indicates higher pain bothersomeness. | 3 months postoperative |
| Pain Interference Short-form 4a |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carrie E Brintz, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt Spine Center | Nashville | Tennessee | 37204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Individual Telehealth Mindfulness | Telehealth mindfulness sessions delivered one-on-one with mindfulness therapist Individual telehealth mindfulness: Participants who enroll and complete lumbar spine surgery will participate in a one-on-one telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 75 minutes each (except the first session which lasts 90 minutes). |
| FG001 | Group Telehealth Mindfulness | Telehealth mindfulness sessions delivered in a small-group format with mindfulness therapist Group telehealth mindfulness: Participants who enroll and complete lumbar spine surgery will participate in a group-delivered telehealth (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 90 minutes each. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The group arm of the study was discontinued due to difficulty enrolling enough participants for a group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Individual Telehealth Mindfulness | Telehealth mindfulness sessions delivered one-on-one with mindfulness therapist Individual telehealth mindfulness: Participants who enroll and complete lumbar spine surgery will participate in a one-on-one telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 75 minutes each (except the first session which lasts 90 minutes). |
| 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 | Percentage of participants enrolled who complete the study | Group arm discontinued | Posted | Count of Participants | Participants | 3 months following lumbar spine surgery |
|
From enrollment (prior to surgery) to 3 months after spine surgery, up to 4 months.
Adverse events collected if they were reported by participants.
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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 | Individual Telehealth Mindfulness | Telehealth mindfulness sessions delivered one-on-one with mindfulness therapist Individual telehealth mindfulness: Participants who enroll and complete lumbar spine surgery will participate in a one-on-one telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 75 minutes each (except the first session which lasts 90 minutes). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carrie Brintz | Vanderbilt University Medical Center | 615-875-9885 | carrie.brintz@vumc.org |
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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 | Nov 22, 2021 | Aug 9, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2022 | Aug 10, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Two-arm, nonrandomized, repeated measures design
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|
| Group telehealth mindfulness | Behavioral | Participants who enroll and complete lumbar spine surgery will participate in a group-delivered telehealth (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 90 minutes each. |
|
Pain Interference short-form 4a from the Patient Reported Outcomes Measurement Information System scale. Measures interference of pain in day to day activities, work around the home, participation in social activities, and household chores over the past 7 days. Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. A lower T-score indicates lower pain interference, or a better outcome.
| 3 months postoperative |
| Overall Pain Intensity | 1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with average pain intensity over the past 7 days rated on 0-10 scale with lower values indicating less pain, or better outcome. | 3 months postoperative |
| Back and Leg Pain Intensity | 2 items assessing back and leg pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome. | 3 months postoperative |
| Self-reported Opioid Medication Use | Measured as average number of opioid pills per day (name and dose specified) and converted to morphine equivalent dose. | 3 months postoperative |
| Anxiety Short Form 4a | Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing anxiety symptoms in the past 7 days (e.g. "I felt fearful"). Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. Lower scores represent lower anxiety, a better outcome. | 3 months postoperative |
| Depression Short Form 4a | Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing depressive symptoms over the past 7 days (e.g. "I felt worthless). Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. A lower score indicates less depression, a better outcome. | 3 months postoperative |
| Oswestry Disability Index | Assesses impact of pain on level of functioning in 10 areas (e.g. walking, sleep, social life). Scores range from 0-100. Lower scores indicate lower level of disability due to pain, a better outcome. | 3 months postoperative |
| Pain Catastrophizing Scale | 13 items assessing thoughts and feelings when in pain (e.g. "I become afraid that the pain will get worse." Scores range from 0-52. Lower scores indicate lower pain catastrophizing, a better outcome. | 3 months postoperative |
| Pain Self-efficacy Questionnaire | 10 items assessing confidence in ability to do certain things despite pain (e.g. "I can enjoy things, despite the pain." Scores range from 0 to 60. Higher scores indicate greater pain self-efficacy, a better outcome. | 3 months postoperative |
| Perceived Stress Scale - 4 | 4 items assessing perceived level of stress in the past month (e.g. "In the last month, how often have you felt that you were unable to control the important things in your life?"). Scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome. | 3 months postoperative |
| Tampa Scale for Kinesiophobia -13 | 13 items assessing fear of movement (e.g. "I'm afraid that I might injure myself if I exercise." Scores range from 13-52. Lower scores indicate lower levels of kinesiophobia, a better outcome. | 3 months postoperative |
| Five Facet Mindfulness Questionnaire - 15 | 15 items assessing 5 facets of mindfulness, including observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Scores range from 1 to 5 (calculated by taking the average of the total sum score). Higher scores indicate higher levels of mindfulness, a better outcome. | 3 months postoperative |
| BG001 | Group Telehealth Mindfulness | Telehealth mindfulness sessions delivered in a small-group format with mindfulness therapist Group telehealth mindfulness: Participants who enroll and complete lumbar spine surgery will participate in a group-delivered telehealth (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 90 minutes each. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Group Telehealth Mindfulness |
Telehealth mindfulness sessions delivered in a small-group format with mindfulness therapist Group telehealth mindfulness: Participants who enroll and complete lumbar spine surgery will participate in a group-delivered telehealth (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 90 minutes each. |
|
|
| Primary | Feasibility - Session Attendance | Percent of sessions attended out of 8 | 5 participants started intervention. Remaining 5 participants withdrew prior to starting intervention. | Posted | Count of Participants | Participants | 3 months following lumbar spine surgery |
|
|
|
| Primary | Acceptability - Satisfaction With Intervention | Nine items assessing satisfaction with the postsurgical telehealth mindfulness intervention (sum of item scores; higher scores indicate higher satisfaction; scores can range from 7 to 55) | Group arm discontinued | Posted | Mean | Standard Deviation | score on a scale | 3 months following lumbar spine surgery |
|
|
|
| Secondary | Pain Bothersomeness | One item assessing how bothersome pain has been in the past 7 days from not at all = 0 to extremely = 4. A higher scores indicates higher pain bothersomeness. | Posted | Mean | Standard Deviation | units on a scale | 3 months postoperative |
|
|
|
| Secondary | Pain Interference Short-form 4a | Pain Interference short-form 4a from the Patient Reported Outcomes Measurement Information System scale. Measures interference of pain in day to day activities, work around the home, participation in social activities, and household chores over the past 7 days. Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. A lower T-score indicates lower pain interference, or a better outcome. | Posted | Mean | Standard Deviation | T-score | 3 months postoperative |
|
|
|
| Secondary | Overall Pain Intensity | 1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with average pain intensity over the past 7 days rated on 0-10 scale with lower values indicating less pain, or better outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months postoperative |
|
|
|
| Secondary | Back and Leg Pain Intensity | 2 items assessing back and leg pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months postoperative |
|
|
|
| Secondary | Self-reported Opioid Medication Use | Measured as average number of opioid pills per day (name and dose specified) and converted to morphine equivalent dose. | Posted | Mean | Standard Deviation | milligrams of morphine equivalents | 3 months postoperative |
|
|
|
| Secondary | Anxiety Short Form 4a | Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing anxiety symptoms in the past 7 days (e.g. "I felt fearful"). Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. Lower scores represent lower anxiety, a better outcome. | Posted | Mean | Standard Deviation | T-score | 3 months postoperative |
|
|
|
| Secondary | Depression Short Form 4a | Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing depressive symptoms over the past 7 days (e.g. "I felt worthless). Raw scores are converted to T-scores with a population mean of 50 and standard deviation of 10. A lower score indicates less depression, a better outcome. | Posted | Mean | Standard Deviation | T-score | 3 months postoperative |
|
|
|
| Secondary | Oswestry Disability Index | Assesses impact of pain on level of functioning in 10 areas (e.g. walking, sleep, social life). Scores range from 0-100. Lower scores indicate lower level of disability due to pain, a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 3 months postoperative |
|
|
|
| Secondary | Pain Catastrophizing Scale | 13 items assessing thoughts and feelings when in pain (e.g. "I become afraid that the pain will get worse." Scores range from 0-52. Lower scores indicate lower pain catastrophizing, a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 3 months postoperative |
|
|
|
| Secondary | Pain Self-efficacy Questionnaire | 10 items assessing confidence in ability to do certain things despite pain (e.g. "I can enjoy things, despite the pain." Scores range from 0 to 60. Higher scores indicate greater pain self-efficacy, a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 3 months postoperative |
|
|
|
| Secondary | Perceived Stress Scale - 4 | 4 items assessing perceived level of stress in the past month (e.g. "In the last month, how often have you felt that you were unable to control the important things in your life?"). Scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 3 months postoperative |
|
|
|
| Secondary | Tampa Scale for Kinesiophobia -13 | 13 items assessing fear of movement (e.g. "I'm afraid that I might injure myself if I exercise." Scores range from 13-52. Lower scores indicate lower levels of kinesiophobia, a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 3 months postoperative |
|
|
|
| Secondary | Five Facet Mindfulness Questionnaire - 15 | 15 items assessing 5 facets of mindfulness, including observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Scores range from 1 to 5 (calculated by taking the average of the total sum score). Higher scores indicate higher levels of mindfulness, a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 3 months postoperative |
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |