An interventional study of Individual telehealth mindfulness and Group telehealth mindfulness in Chronic Low-back Pain, Postsurgical Pain and Opioid Use, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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:
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 10 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 159 are open to participants now.
Of its 124 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Telehealth mindfulness sessions delivered one-on-one with mindfulness therapist
Behavioral: Individual telehealth mindfulness
Telehealth mindfulness sessions delivered in a small-group format with mindfulness therapist
Behavioral: Group 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).
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.
Feasibility - Study Retention
Percentage of participants enrolled who complete the study
Time frame: 3 months following lumbar spine surgery
Feasibility - Session Attendance
Percent of sessions attended out of 8
Time frame: 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)
Time frame: 3 months following lumbar spine surgery
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.
Time frame: 3 months postoperative
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months postoperative
| Milestone | Individual Telehealth Mindfulness | Group Telehealth Mindfulness |
|---|---|---|
| Started | 10 | 0 |
| Completed | 3 | 0 |
| Not completed | 7 | 0 |
Percentage of participants enrolled who complete the study
| Participants | Individual Telehealth Mindfulness | Group Telehealth Mindfulness |
|---|---|---|
| Feasibility - Study Retention | 3 | — |
Percent of sessions attended out of 8
| Participants | Individual Telehealth Mindfulness | Group Telehealth Mindfulness |
|---|---|---|
| 8 sessions | 3 | — |
| 3 sessions | 1 | — |
| 1 session | 1 | — |
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)
| score on a scale | Individual Telehealth Mindfulness | Group Telehealth Mindfulness |
|---|---|---|
| Acceptability - Satisfaction With Intervention | 53.0 ± 2.0 | — |
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.
| units on a scale | Individual Telehealth Mindfulness |
|---|---|
| Pain Bothersomeness | 0.3 ± 0.6 |
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.
| T-score | Individual Telehealth Mindfulness |
|---|---|
| Pain Interference Short-form 4a | 46.3 ± 8.1 |
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.
| units on a scale | Individual Telehealth Mindfulness |
|---|---|
| Overall Pain Intensity | 0.7 ± 0.6 |
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.
| units on a scale | Individual Telehealth Mindfulness |
|---|---|
| Back pain | 0.7 ± 0.6 |
| Leg Pain | 0.3 ± 0.6 |
Measured as average number of opioid pills per day (name and dose specified) and converted to morphine equivalent dose.
| milligrams of morphine equivalents | Individual Telehealth Mindfulness |
|---|---|
| Self-reported Opioid Medication Use | 0.0 ± 0.0 |
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.
| T-score | Individual Telehealth Mindfulness |
|---|---|
| Anxiety Short Form 4a | 40.3 ± 0.0 |
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.
| T-score | Individual Telehealth Mindfulness |
|---|---|
| Depression Short Form 4a | 43.6 ± 4.6 |
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.
| score on a scale | Individual Telehealth Mindfulness |
|---|---|
| Oswestry Disability Index | 18.0 ± 19.1 |
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.
| score on a scale | Individual Telehealth Mindfulness |
|---|---|
| Pain Catastrophizing Scale | 1.3 ± 2.3 |
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.
| score on a scale | Individual Telehealth Mindfulness |
|---|---|
| Pain Self-efficacy Questionnaire | 52.7 ± 12.7 |
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.
| score on a scale | Individual Telehealth Mindfulness |
|---|---|
| Perceived Stress Scale - 4 | 4.0 ± 4.0 |
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.
| score on a scale | Individual Telehealth Mindfulness |
|---|---|
| Tampa Scale for Kinesiophobia -13 | 24.5 ± 8.4 |
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.
| score on a scale | Individual Telehealth Mindfulness |
|---|---|
| Five Facet Mindfulness Questionnaire - 15 | 3.8 ± 0.5 |
Collected over From enrollment (prior to surgery) to 3 months after spine surgery, up to 4 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Individual Telehealth Mindfulness | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
The group arm of the study was discontinued due to difficulty enrolling enough participants for a group.
| Age, Continuous(years) | Individual Telehealth Mindfulness | Group Telehealth Mindfulness | Total |
|---|---|---|---|
| Mean | 62.3 ± 16.6 | — | 62.3 ± 16.6 |
| Sex: Female, Male(Participants) | Individual Telehealth Mindfulness | Group Telehealth Mindfulness | Total |
|---|---|---|---|
| Female | 3 | — | 3 |
| Male | 7 | — | 7 |
| Ethnicity (NIH/OMB)(Participants) | Individual Telehealth Mindfulness | Group Telehealth Mindfulness | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | — | 0 |
| Not Hispanic or Latino | 10 | — | 10 |
| Unknown or Not Reported | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | Individual Telehealth Mindfulness | Group Telehealth Mindfulness | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 1 | — | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 2 | — | 2 |
| White | 5 | — | 5 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 2 | — | 2 |
| Education(Participants) | Individual Telehealth Mindfulness | Group Telehealth Mindfulness | Total |
|---|---|---|---|
| High School diploma or GED | 3 | — | 3 |
| Two- or Four-year college degree | 3 | — | 3 |
| Post-college | 2 | — | 2 |
| Unknown or not reported | 2 | — | 2 |
| Employment(Participants) | Individual Telehealth Mindfulness | Group Telehealth Mindfulness | Total |
|---|---|---|---|
| Employed and currently working | 2 | — | 2 |
| Employed but not working (short-term disability or leave) | 2 | — | 2 |
| Unemployed | 3 | — | 3 |
| Unknown or not reported | 3 | — | 3 |
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