Trial Outcomes & Findings for Meditation-CBT for Opioid-treated Chronic Low Back Pain (NCT NCT01775995)

NCT ID: NCT01775995

Last Updated: 2016-05-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: baseline to 8 weeks
• Results posted on: 2016-05-16

Participant Flow

Participant milestones

Measure	Meditation-CBT Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Overall Study STARTED	21	14
Overall Study COMPLETED	20	13
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Meditation-CBT Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Meditation-CBT for Opioid-treated Chronic Low Back Pain

Baseline characteristics by cohort

Measure	Experimental: Meditation-CBT n=21 Participants 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.	Wait-list Control n=14 Participants Standard of Care Therapy only	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	52.7 years STANDARD_DEVIATION 10.5 • n=5 Participants	50.5 years STANDARD_DEVIATION 8.6 • n=7 Participants	51.8 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	13 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	14 participants n=7 Participants	35 participants n=5 Participants
Physical Function	68.1 percent STANDARD_DEVIATION 9.3 • n=5 Participants	64.5 percent STANDARD_DEVIATION 14.1 • n=7 Participants	66.7 percent STANDARD_DEVIATION 11.4 • n=5 Participants
Averaged Pain	6.3 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	4.9 units on a scale STANDARD_DEVIATION 1.1 • n=7 Participants	5.8 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants
Opioid Use	166.9 mg/day STANDARD_DEVIATION 153.7 • n=5 Participants	120.3 mg/day STANDARD_DEVIATION 76.9 • n=7 Participants	148.3 mg/day STANDARD_DEVIATION 129.2 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Health-Related Quality of Life: Averaged Pain Severity	-0.5 units on a scale Interval -1.1 to 0.03	0.4 units on a scale Interval -0.3 to 1.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=13 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Health-Related Quality of Life: Averaged Pain Severity	-0.5 units on a scale Interval -1.1 to 0.02	0.5 units on a scale Interval -0.2 to 1.2

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Health-Related Quality of Life: Physical Function	-2.4 percentage disability Interval -7.2 to 2.3	-0.6 percentage disability Interval -6.2 to 5.1

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=13 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Health-Related Quality of Life: Physical Function	-5.0 percentage disability Interval -9.7 to -0.2	1.6 percentage disability Interval -4.3 to 7.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Opioid Dose	-7.1 morphine-equivalent mg/day Interval -32.5 to 18.3	-1.4 morphine-equivalent mg/day Interval -32.3 to 29.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=13 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Opioid Dose	-10.1 morphine-equivalent mg/day Interval -35.5 to 15.2	-0.2 morphine-equivalent mg/day Interval -31.4 to 30.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.

Outcome measures

Measure	Meditation-CBT n=21 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Alcohol Use	28.6 percentage using alcohol	21.4 percentage using alcohol

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Alcohol Use	30.0 percentage using alcohol	42.9 percentage using alcohol

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=13 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Alcohol Use	20.0 percentage using alcohol	38.5 percentage using alcohol

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.

Outcome measures

Measure	Meditation-CBT n=21 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Drug Use	28.6 percentage using drugs	14.2 percentage using drugs

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Drug Use	35.0 percentage using drugs	7.1 percentage using drugs

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=13 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Drug Use	30.0 percentage using drugs	7.7 percentage using drugs

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Chronic Pain Acceptance	5.9 units on a scale Interval -0.6 to 12.4	3.2 units on a scale Interval -4.7 to 11.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=13 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Chronic Pain Acceptance	14.7 units on a scale Interval 8.1 to 21.2	9.3 units on a scale Interval 1.3 to 17.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Perceived Stress	0.6 units on a scale Interval -2.5 to 3.6	0.2 units on a scale Interval -3.5 to 3.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=13 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Perceived Stress	-1.7 units on a scale Interval -4.8 to 1.3	-1.8 units on a scale Interval -5.6 to 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Mental Health Symptom Severity	-0.03 units on a scale Interval -0.2 to 0.1	-0.1 units on a scale Interval -0.3 to 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=13 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Mental Health Symptom Severity	-0.2 units on a scale Interval -0.3 to -0.01	-0.3 units on a scale Interval -0.5 to -0.04

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Depression Symptom Severity	0.04 units on a scale Interval -0.2 to 0.3	-0.1 units on a scale Interval -0.5 to 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=13 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Depression Symptom Severity	-0.3 units on a scale Interval -0.6 to 0.02	-0.4 units on a scale Interval -0.7 to -0.02

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Anxiety Symptom Severity	-0.2 units on a scale Interval -0.4 to 0.1	-0.3 units on a scale Interval -0.5 to 0.03

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=13 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Anxiety Symptom Severity	-0.2 units on a scale Interval -0.4 to 0.05	-0.3 units on a scale Interval -0.5 to 0.02

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Emotion Regulation Difficulty	-0.8 units on a scale Interval -8.3 to 6.7	-1.6 units on a scale Interval -10.7 to 7.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation-CBT n=20 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=13 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Emotion Regulation Difficulty	-4.0 units on a scale Interval -11.7 to 3.6	-4.2 units on a scale Interval -13.5 to 5.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Measure	Meditation-CBT n=18 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
C-Reactive Protein	-0.9 mg/dL Interval -1.7 to -0.1	0.1 mg/dL Interval -0.9 to 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Measure	Meditation-CBT n=15 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=13 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
C-Reactive Protein	-0.7 mg/dL Interval -1.6 to 0.1	0.1 mg/dL Interval -0.9 to 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Measure	Meditation-CBT n=21 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Economic Outcomes	16443 dollars Standard Deviation 15634	14284 dollars Standard Deviation 11091

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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).

Outcome measures

Measure	Meditation-CBT n=21 Participants Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.	Wait-list Control n=14 Participants Usual Care Participants receiving usual care for CLBP and opioid therapy management.
Economic Outcomes	11576 dollars Standard Deviation 8347	11697 dollars Standard Deviation 9876

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Experimental: Meditation-CBT

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Wait-list Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Experimental: Meditation-CBT n=21 participants at risk 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.	Wait-list Control n=14 participants at risk Standard of Care Therapy only
General disorders Increased cigarette smoking	4.8% 1/21 • Number of events 1	0.00% 0/14
General disorders Weight gain	4.8% 1/21 • Number of events 1	0.00% 0/14
Musculoskeletal and connective tissue disorders Increased pain	9.5% 2/21 • Number of events 2	0.00% 0/14
General disorders Anxiety/Emotional Distress	14.3% 3/21 • Number of events 3	0.00% 0/14

Additional Information

Aleksandra Zgierska, MD PhD

University of Wisconsin Madison

Phone: (608) 263-7882

Email: aleksandra.zgierska@fammed.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place