Chronic Pain, Low Back Pain
Conditions
Keywords
Chronic Pain, Low Back Pain
Brief summary
Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. It is often refractory to treatment, with patients requiring long-term opioid therapy. Mindfulness meditation is a promising treatment for chronic pain, mental health and addictive disorders. When combined with cognitive behavioral therapy (CBT), a standard of care for CLBP, it may produce additive benefits. The goal of this randomized controlled trial (RCT) is to evaluate the feasibility and efficacy of an innovative behavioral intervention to improve the health of adults with opioid-treated CLBP. This RCT will test the hypotheses that, at 26 weeks, meditation-CBT group participants (meditation-CBT + usual care), compared to those in a wait-list control group (usual care alone), will improve health-related quality of life (primary outcomes: pain severity and physical function) and reduce opioid medication use (secondary outcome). In addition, they will also decrease alcohol and drug use/misuse, and improve stress-sensitive measures and economic outcomes.
Detailed description
Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. Treatment for refractory CLBP includes long-term opioid therapy even though it is often only marginally effective. Prescription opioid abuse is a national epidemic. Development of safe, effective non-addictive therapies for chronic pain is a national priority. Mindfulness meditation is a promising, safe treatment for chronic pain, mental health and addictive disorders. When combined with cognitive behavioral therapy (CBT), a standard of care for CLBP, it may produce additive benefits. No study has evaluated the potential of a combined meditation-CBT intervention to improve outcomes in patients with opioid-treated CLBP. This unblinded 26-week pilot randomized controlled trial (RCT) will test methods feasibility and efficacy of meditation-CBT for improving health-related quality of life (primary outcomes: pain severity and physical function) and reduce opioid medication use (secondary outcome) among adults with opioid-treated CLBP. Eligible participants are adults at least 21 years old, with daily CLBP treated with daily opioids (at least 30 morphine-equivalent mg/day) for at least 3 months. They will be recruited from outpatient clinic and community settings, and randomly assigned to one of two study arms: meditation-CBT + usual care or usual care alone. The targeted meditation-CBT intervention will consist of a) therapist-led group training (two-hours/week for 8 weeks), and b) at-home meditation practice (at least 30 minutes/day, 6 days/week). Control participants will be offered the intervention after their study completion. Outcome measures, collected at 0, 8 (directly post-intervention) and 26 (18 weeks post-intervention) weeks will gather data on efficacy and potential mechanisms of action of meditation-CBT intervention. This RCT will test the hypotheses that, at 26 weeks, meditation-CBT group participants (meditation-CBT + usual care), compared to those in a wait-list control group (usual care alone), will improve health-related quality of life (primary outcomes: pain severity and physical function) and reduce opioid medication use (secondary outcome). In addition, they will also decrease alcohol and drug use/misuse, and improve stress-sensitive measures and economic outcomes. Increased pain acceptance, mindfulness level or stress reduction are hypothesized to be the mechanistic pathways. This study directly addresses national priorities aimed at the development of an effective, safe treatment for CLBP and reduction of opioid use. Potential benefits accruing from positive findings include improved quality of life and reduced opioid pain medication use among patients with refractory, opioid-treated CLBP.
Interventions
OTHERUsual Care Alone
All participants receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
BEHAVIORALMeditation-CBT Intervention + Usual Care
The intervention combines meditation and standard-of-care CBT strategies for chronic low back pain. It consists of eight weekly 2-hour group sessions guided by trained instructors. In addition to session attendance, experimental participants are asked to practice meditation at home at least 6 days/week, 30 minutes/day during the 26-week study. Control participants will be offered the intervention after completing the study. All participants receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 21 years old * Chronic low back pain defined as a daily pain in the lumbosacral region or radiating to the leg (sciatica) * Pain lasting for and treated with clinician-prescribed daily opioids (≥ 30mg of morphine equivalent dose, MED) for ≥ 3 months * Has the ability to feel warm and cold temperature sensations in both hands (for pain psychophysical testing) * English fluent
Exclusion criteria
* Experience in meditation (current, regular practice in the past 12 months or past formal training) * Inability to reliably participate * Self-reported current pregnancy * Preexisting delusional, bipolar, or borderline personality disorders * Individuals lacking consent capacity and prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life: Averaged Pain Severity | baseline to 8 weeks | Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased pain and negative values indicating decreased pain. |
| Health-Related Quality of Life: Physical Function | baseline to 8 weeks | Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability today. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased disability and negative values indicating decreased disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Dose | baseline to 8 weeks | Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized \[daily morphine-equivalent dose (MED)\] across different opioids for each participant. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress | baseline to 8 weeks | Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful in the last month. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress. |
| Mental Health Symptom Severity | baseline to 8 weeks | Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress during the past 7 days. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress. |
| Depression Symptom Severity | baseline to 8 weeks | Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms during the past 7 days. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms. |
| Anxiety Symptom Severity | baseline to 8 weeks | Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms during the past 7 days. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms. |
| Alcohol Use | Baseline | Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method. |
| C-Reactive Protein | baseline to 8 weeks | Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure). |
| Economic Outcomes | 6 months prior to baseline, to baseline (enrollment) | Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed. Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs. Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day). |
| Pain Sensitivity to Experimental Thermal Stimuli | 0, 8, 26 weeks | Pain sensitivity to thermal stimuli was assessed using standard psychophysical procedures. Thermal stimuli, ranging from 43 to 49oC, were applied to the thenar eminence of the right hand. Each stimulus was rated on two separate, validated 0-20 category-ratio scales assessing pain intensity and unpleasantness. |
| Emotion Regulation Difficulty | baseline to 8 weeks | Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified). This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty. |
| Drug Use | Baseline | Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method. |
| Chronic Pain Acceptance | baseline to 8 weeks | Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Meditation-CBT Mindfulness-CBT + Standard of Care Therapy
Mindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study. | 21 |
| Wait-list Control Standard of Care Therapy only | 14 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Experimental: Meditation-CBT | Wait-list Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 13 Participants | 31 Participants |
| Age, Continuous | 52.7 years STANDARD_DEVIATION 10.5 | 50.5 years STANDARD_DEVIATION 8.6 | 51.8 years STANDARD_DEVIATION 9.7 |
| Averaged Pain | 6.3 units on a scale STANDARD_DEVIATION 1.2 | 4.9 units on a scale STANDARD_DEVIATION 1.1 | 5.8 units on a scale STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 13 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Opioid Use | 166.9 mg/day STANDARD_DEVIATION 153.7 | 120.3 mg/day STANDARD_DEVIATION 76.9 | 148.3 mg/day STANDARD_DEVIATION 129.2 |
| Physical Function | 68.1 percent STANDARD_DEVIATION 9.3 | 64.5 percent STANDARD_DEVIATION 14.1 | 66.7 percent STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 12 Participants | 28 Participants |
| Region of Enrollment United States | 21 participants | 14 participants | 35 participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 6 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 21 | 0 / 14 |
| serious Total, serious adverse events | 0 / 21 | 0 / 14 |
Outcome results
Primary
Health-Related Quality of Life: Averaged Pain Severity
Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased pain and negative values indicating decreased pain.
Time frame: baseline to 8 weeks
Population: One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Health-Related Quality of Life: Averaged Pain Severity | -0.5 units on a scale |
| Wait-list Control | Health-Related Quality of Life: Averaged Pain Severity | 0.4 units on a scale |
Primary
Health-Related Quality of Life: Averaged Pain Severity
Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now. This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased pain and negative values indicating decreased pain.
Time frame: baseline to 26 weeks
Population: One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Health-Related Quality of Life: Averaged Pain Severity | -0.5 units on a scale |
| Wait-list Control | Health-Related Quality of Life: Averaged Pain Severity | 0.5 units on a scale |
Primary
Health-Related Quality of Life: Physical Function
Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability today. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased disability and negative values indicating decreased disability.
Time frame: baseline to 8 weeks
Population: One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Health-Related Quality of Life: Physical Function | -2.4 percentage disability |
| Wait-list Control | Health-Related Quality of Life: Physical Function | -0.6 percentage disability |
Primary
Health-Related Quality of Life: Physical Function
Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability today. This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased disability and negative values indicating decreased disability.
Time frame: baseline to 26 weeks
Population: One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Health-Related Quality of Life: Physical Function | -5.0 percentage disability |
| Wait-list Control | Health-Related Quality of Life: Physical Function | 1.6 percentage disability |
Secondary
Opioid Dose
Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized \[daily morphine-equivalent dose (MED)\] across different opioids for each participant. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose.
Time frame: baseline to 8 weeks
Population: One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Opioid Dose | -7.1 morphine-equivalent mg/day |
| Wait-list Control | Opioid Dose | -1.4 morphine-equivalent mg/day |
Secondary
Opioid Dose
Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized \[daily morphine-equivalent dose (MED)\] across different opioids for each participant. This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose.
Time frame: baseline to 26 weeks
Population: One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Opioid Dose | -10.1 morphine-equivalent mg/day |
| Wait-list Control | Opioid Dose | -0.2 morphine-equivalent mg/day |
Other Pre-specified
Alcohol Use
Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Meditation-CBT | Alcohol Use | 28.6 percentage using alcohol |
| Wait-list Control | Alcohol Use | 21.4 percentage using alcohol |
Other Pre-specified
Alcohol Use
Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.
Time frame: 8 weeks
Population: One Meditation-CBT participant did not provide data for this measure at 8 week follow-up. Results for this measure are based on the number of participants analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Meditation-CBT | Alcohol Use | 30.0 percentage using alcohol |
| Wait-list Control | Alcohol Use | 42.9 percentage using alcohol |
Other Pre-specified
Alcohol Use
Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.
Time frame: 26 weeks
Population: One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26 week follow-up. Results for this measure are based on the number of participants analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Meditation-CBT | Alcohol Use | 20.0 percentage using alcohol |
| Wait-list Control | Alcohol Use | 38.5 percentage using alcohol |
Other Pre-specified
Anxiety Symptom Severity
Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms during the past 7 days. This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms.
Time frame: baseline to 26 weeks
Population: One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Anxiety Symptom Severity | -0.2 units on a scale |
| Wait-list Control | Anxiety Symptom Severity | -0.3 units on a scale |
Other Pre-specified
Anxiety Symptom Severity
Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms during the past 7 days. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms.
Time frame: baseline to 8 weeks
Population: One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Anxiety Symptom Severity | -0.2 units on a scale |
| Wait-list Control | Anxiety Symptom Severity | -0.3 units on a scale |
Other Pre-specified
Chronic Pain Acceptance
Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance.
Time frame: baseline to 8 weeks
Population: One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Chronic Pain Acceptance | 5.9 units on a scale |
| Wait-list Control | Chronic Pain Acceptance | 3.2 units on a scale |
Other Pre-specified
Chronic Pain Acceptance
Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame. This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance.
Time frame: baseline to 26 weeks
Population: One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Chronic Pain Acceptance | 14.7 units on a scale |
| Wait-list Control | Chronic Pain Acceptance | 9.3 units on a scale |
Other Pre-specified
C-Reactive Protein
Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes. This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure).
Time frame: baseline to 26 weeks
Population: Six Meditation-CBT participants and one Wait-list Control participant did not provide biological data at 26 week follow-up. Results for this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | C-Reactive Protein | -0.7 mg/dL |
| Wait-list Control | C-Reactive Protein | 0.1 mg/dL |
Other Pre-specified
C-Reactive Protein
Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure).
Time frame: baseline to 8 weeks
Population: Three Meditation-CBT participants did not provide biological data at 8 week follow-up. Results for this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | C-Reactive Protein | -0.9 mg/dL |
| Wait-list Control | C-Reactive Protein | 0.1 mg/dL |
Other Pre-specified
Depression Symptom Severity
Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms during the past 7 days. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms.
Time frame: baseline to 8 weeks
Population: One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Depression Symptom Severity | 0.04 units on a scale |
| Wait-list Control | Depression Symptom Severity | -0.1 units on a scale |
Other Pre-specified
Depression Symptom Severity
Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms during the past 7 days. This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms.
Time frame: baseline to 26 weeks
Population: One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Depression Symptom Severity | -0.3 units on a scale |
| Wait-list Control | Depression Symptom Severity | -0.4 units on a scale |
Other Pre-specified
Drug Use
Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.
Time frame: 26 weeks
Population: One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26 week follow-up. Results for this measure are based on the number of participants analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Meditation-CBT | Drug Use | 30.0 percentage using drugs |
| Wait-list Control | Drug Use | 7.7 percentage using drugs |
Other Pre-specified
Drug Use
Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.
Time frame: 8 weeks
Population: One Meditation-CBT participant did not provide data for this measure at 8 week follow-up. Results for this measure are based on the number of participants analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Meditation-CBT | Drug Use | 35.0 percentage using drugs |
| Wait-list Control | Drug Use | 7.1 percentage using drugs |
Other Pre-specified
Drug Use
Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Meditation-CBT | Drug Use | 28.6 percentage using drugs |
| Wait-list Control | Drug Use | 14.2 percentage using drugs |
Other Pre-specified
Economic Outcomes
Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed. Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs. Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day).
Time frame: 6 months prior to baseline, to baseline (enrollment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation-CBT | Economic Outcomes | 16443 dollars | Standard Deviation 15634 |
| Wait-list Control | Economic Outcomes | 14284 dollars | Standard Deviation 11091 |
Other Pre-specified
Economic Outcomes
Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed. Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs. Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day).
Time frame: From enrollment to 26 week follow-up (6 months)
Population: One meditation-CBT participant did not provide data at 8-week follow-up; two participants (one meditation-CBT, one control) did not provide data at 26-week follow-up. All 35 participants were included in the analysis; missing participant data was imputed based on existing data for the given participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation-CBT | Economic Outcomes | 11576 dollars | Standard Deviation 8347 |
| Wait-list Control | Economic Outcomes | 11697 dollars | Standard Deviation 9876 |
Other Pre-specified
Emotion Regulation Difficulty
Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified). This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty.
Time frame: baseline to 8 weeks
Population: One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Emotion Regulation Difficulty | -0.8 units on a scale |
| Wait-list Control | Emotion Regulation Difficulty | -1.6 units on a scale |
Other Pre-specified
Emotion Regulation Difficulty
Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified). This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty.
Time frame: baseline to 26 weeks
Population: One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Emotion Regulation Difficulty | -4.0 units on a scale |
| Wait-list Control | Emotion Regulation Difficulty | -4.2 units on a scale |
Other Pre-specified
Mental Health Symptom Severity
Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress during the past 7 days. This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress.
Time frame: baseline to 26 weeks
Population: One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Mental Health Symptom Severity | -0.2 units on a scale |
| Wait-list Control | Mental Health Symptom Severity | -0.3 units on a scale |
Other Pre-specified
Mental Health Symptom Severity
Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress during the past 7 days. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress.
Time frame: baseline to 8 weeks
Population: One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Mental Health Symptom Severity | -0.03 units on a scale |
| Wait-list Control | Mental Health Symptom Severity | -0.1 units on a scale |
Other Pre-specified
Pain Sensitivity to Experimental Thermal Stimuli
Pain sensitivity to thermal stimuli was assessed using standard psychophysical procedures. Thermal stimuli, ranging from 43 to 49oC, were applied to the thenar eminence of the right hand. Each stimulus was rated on two separate, validated 0-20 category-ratio scales assessing pain intensity and unpleasantness.
Time frame: 0, 8, 26 weeks
Other Pre-specified
Perceived Stress
Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful in the last month. This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress.
Time frame: baseline to 26 weeks
Population: One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Perceived Stress | -1.7 units on a scale |
| Wait-list Control | Perceived Stress | -1.8 units on a scale |
Other Pre-specified
Perceived Stress
Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful in the last month. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress.
Time frame: baseline to 8 weeks
Population: One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Meditation-CBT | Perceived Stress | 0.6 units on a scale |
| Wait-list Control | Perceived Stress | 0.2 units on a scale |