Trial Outcomes & Findings for Strategies to Assist With Management of Pain (NCT NCT03115359)

NCT ID: NCT03115359

Last Updated: 2024-09-19

Results Overview

Averaged 4 pain severity items from the Brief Pain Inventory (0-10 scale; higher indicates higher level of pain)

Recruitment status

COMPLETED

Study phase

Target enrollment

770 participants

Primary outcome timeframe

6 months post-entry

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Mindfulness Based Therapy Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Overall Study STARTED	385	385
Overall Study COMPLETED	266	263
Overall Study NOT COMPLETED	119	122

Reasons for withdrawal

Reasons for withdrawal
Measure	Mindfulness Based Therapy Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Overall Study Withdrawal by Subject	29	39
Overall Study Scheduling conflict	25	23
Overall Study Personal reasons including health	12	9
Overall Study Transportation barriers	3	0
Overall Study No longer interested	5	4
Overall Study No reason provided	45	47

Baseline Characteristics

Strategies to Assist With Management of Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness Based Therapy n=385 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=385 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Total n=770 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 10.9 • n=5 Participants	58.0 years STANDARD_DEVIATION 11.7 • n=7 Participants	57.8 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex/Gender, Customized Female	233 Participants n=5 Participants	201 Participants n=7 Participants	434 Participants n=5 Participants
Sex/Gender, Customized Male	147 Participants n=5 Participants	181 Participants n=7 Participants	328 Participants n=5 Participants
Sex/Gender, Customized missing, declined, unknown, unspecified	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	316 Participants n=5 Participants	331 Participants n=7 Participants	647 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	52 Participants n=5 Participants	36 Participants n=7 Participants	88 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	33 Participants n=5 Participants	37 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) White	307 Participants n=5 Participants	310 Participants n=7 Participants	617 Participants n=5 Participants
Race (NIH/OMB) More than one race	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	26 Participants n=5 Participants	20 Participants n=7 Participants	46 Participants n=5 Participants
Composite Pain Severity	6.0 score on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	6.2 score on a scale STANDARD_DEVIATION 1.5 • n=7 Participants	6.1 score on a scale STANDARD_DEVIATION 1.5 • n=5 Participants
Physical Function	47.3 score on a scale STANDARD_DEVIATION 13.6 • n=5 Participants	47.0 score on a scale STANDARD_DEVIATION 14.3 • n=7 Participants	47.2 score on a scale STANDARD_DEVIATION 14.0 • n=5 Participants
Health-Related Quality of Life (Physical Health)	28.8 score on a scale STANDARD_DEVIATION 8.1 • n=5 Participants	28.2 score on a scale STANDARD_DEVIATION 8.5 • n=7 Participants	28.5 score on a scale STANDARD_DEVIATION 8.3 • n=5 Participants
Health-Related Quality of Life (Mental Health)	41.6 score on a scale STANDARD_DEVIATION 11.1 • n=5 Participants	43.3 score on a scale STANDARD_DEVIATION 12.4 • n=7 Participants	42.5 score on a scale STANDARD_DEVIATION 11.8 • n=5 Participants
Average Daily Opioid Dose	163 morphine-MG equivalent dose per day STANDARD_DEVIATION 601 • n=5 Participants	191 morphine-MG equivalent dose per day STANDARD_DEVIATION 1344 • n=7 Participants	177 morphine-MG equivalent dose per day STANDARD_DEVIATION 1041 • n=5 Participants
Negative Affect	16.7 score on a scale STANDARD_DEVIATION 7.2 • n=5 Participants	16.2 score on a scale STANDARD_DEVIATION 8.0 • n=7 Participants	16.4 score on a scale STANDARD_DEVIATION 7.6 • n=5 Participants
Negative Affect Score greater than 11	289 Participants n=5 Participants	261 Participants n=7 Participants	550 Participants n=5 Participants
Negative Affect Score less than or equal to 11	96 Participants n=5 Participants	123 Participants n=7 Participants	219 Participants n=5 Participants
Negative Affect Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Opioid Use Behaviors	9.2 score on a scale STANDARD_DEVIATION 6.4 • n=5 Participants	10.0 score on a scale STANDARD_DEVIATION 7.4 • n=7 Participants	9.6 score on a scale STANDARD_DEVIATION 6.0 • n=5 Participants
Opioid Use Behaviors scores greater than or equal to 9	174 Participants n=5 Participants	175 Participants n=7 Participants	349 Participants n=5 Participants
Opioid Use Behaviors scores less than 9	209 Participants n=5 Participants	207 Participants n=7 Participants	416 Participants n=5 Participants
Opioid Use Behaviors Missing	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Average Pain Severity	6.0 score on a scale STANDARD_DEVIATION 1.5 • n=5 Participants	6.2 score on a scale STANDARD_DEVIATION 1.7 • n=7 Participants	6.1 score on a scale STANDARD_DEVIATION 1.6 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months post-entry

Population: Number of participants analyzed varies due to some participants not providing data for a given measure(s). Reasons for missing data include participants declining to answer a particular question/survey, participant withdrawals, lost to follow up.

Averaged 4 pain severity items from the Brief Pain Inventory (0-10 scale; higher indicates higher level of pain)

Outcome measures

Outcome measures
Measure	Mindfulness Based Therapy n=253 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=227 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Composite Pain Severity	5.6 score on a scale Standard Deviation 1.7	5.6 score on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: 12 months post-entry

Averaged 4 pain severity items from the Brief Pain Inventory (0-10 scale; higher indicates higher level of pain)

Outcome measures

Outcome measures
Measure	Mindfulness Based Therapy n=249 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=232 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Composite Pain Severity	5.5 score on a scale Standard Deviation 1.8	5.5 score on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: 6 months post-entry

10-item Oswestry Disability Index (0-100 scale; higher score indicates higher level of back pain-related functional limitation)

Outcome measures

Outcome measures
Measure	Mindfulness Based Therapy n=250 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=226 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Physical Function	44.6 score on a scale Standard Deviation 16.1	45.1 score on a scale Standard Deviation 16.4

PRIMARY outcome

Timeframe: 12 months post-entry

10-item Oswestry Disability Index (0-100 scale; higher score indicates higher level of back pain-related functional limitation)

Outcome measures

Outcome measures
Measure	Mindfulness Based Therapy n=249 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=232 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Physical Function	43.4 score on a scale Standard Deviation 15.3	43.2 score on a scale Standard Deviation 15.4

PRIMARY outcome

Timeframe: 6 months post-entry

1 'average' pain severity item from the Brief Pain Inventory (0-10 scale; higher score indicates higher level of pain)

Outcome measures

Outcome measures
Measure	Mindfulness Based Therapy n=253 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=227 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Average Pain Severity	5.6 score on a scale Standard Deviation 1.7	5.5 score on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: 12 months post-entry

1 'average' pain severity item from the Brief Pain Inventory (0-10 scale; higher score indicates higher level of pain)

Outcome measures

Outcome measures
Measure	Mindfulness Based Therapy n=249 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=232 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Average Pain Severity	5.4 score on a scale Standard Deviation 1.9	5.5 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 6 months post-entry

12-item Short Form-12 (0-100 scale; higher score indicates better physical health function)

Outcome measures

Outcome measures
Measure	Mindfulness Based Therapy n=250 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=226 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Health-Related Quality of Life (Physical Health)	30.7 score on a scale Standard Deviation 8.7	29.9 score on a scale Standard Deviation 9.4

SECONDARY outcome

Timeframe: 12 months post-entry

12-item Short Form-12 (0-100 scale; higher indicates better physical health function)

Outcome measures

Outcome measures
Measure	Mindfulness Based Therapy n=248 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=232 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Health-Related Quality of Life (Physical Health)	30.5 score on a scale Standard Deviation 8.8	30.0 score on a scale Standard Deviation 9.2

SECONDARY outcome

Timeframe: 6 months post-entry

12-item Short Form-12 (0-100 scale; higher score indicates better mental health function)

Outcome measures

Outcome measures
Measure	Mindfulness Based Therapy n=250 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=226 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Health-Related Quality of Life (Mental Health)	43.2 score on a scale Standard Deviation 11.4	43.5 score on a scale Standard Deviation 12.1

SECONDARY outcome

Timeframe: 12 months post-entry

12-item Short Form-12 (0-100 scale; higher score indicates better mental health function)

Outcome measures

Outcome measures
Measure	Mindfulness Based Therapy n=248 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=232 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Health-Related Quality of Life (Mental Health)	43.5 score on a scale Standard Deviation 11.5	45.9 score on a scale Standard Deviation 11.0

SECONDARY outcome

Timeframe: 6 months post-entry

Timeline Followback Method (morphine-MG equivalent dose \[mg/day\] over the prior 14 days). Log transformation was required because of the skewed distribution of the daily opioid dose data in the primary effectiveness analysis.

Outcome measures

Outcome measures
Measure	Mindfulness Based Therapy n=269 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=250 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Average Daily Opioid Dose	119 morphine-MG equivalent dose per day Standard Deviation 521	191 morphine-MG equivalent dose per day Standard Deviation 1603

SECONDARY outcome

Timeframe: 12 months post-entry

Outcome measures

Outcome measures
Measure	Mindfulness Based Therapy n=253 Participants Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=237 Participants Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Average Daily Opioid Dose	144 morphine-MG equivalent dose per day Standard Deviation 556	192 morphine-MG equivalent dose per day Standard Deviation 1644

Adverse Events

Mindfulness Based Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Cognitive Behavioral Therapy

Serious events: 0 serious events

Other events: 24 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mindfulness Based Therapy n=385 participants at risk Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Cognitive Behavioral Therapy n=385 participants at risk Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
Musculoskeletal and connective tissue disorders Increased pain reported as associated with progressive muscle relaxation exercise	0.00% 0/385 • Adverse events were collected from enrollment through exit (12-month follow-up period) for each participant. Data on adverse events were systematically collected with a "negative side effects" survey at each assessment, and at each intervention session. In addition, study personnel inquired about potential adverse events at each participant contact. All adverse events were recorded, reported, and categorized according to the funding agency, IRB, and other regulatory guidance. Definitions from study protocol: 10.1.1 AE: Any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. 10.1.2 SAE Any of the following: Fatal; life-threatening; persistent/significantly disabling/incapacitating; inpatient hospitalization/prolongation of hospitalization; significant medical incident that may jeopardize the participant and requires medical/surgical intervention to prevent one of the above outcomes	6.2% 24/385 • Number of events 38 • Adverse events were collected from enrollment through exit (12-month follow-up period) for each participant. Data on adverse events were systematically collected with a "negative side effects" survey at each assessment, and at each intervention session. In addition, study personnel inquired about potential adverse events at each participant contact. All adverse events were recorded, reported, and categorized according to the funding agency, IRB, and other regulatory guidance. Definitions from study protocol: 10.1.1 AE: Any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. 10.1.2 SAE Any of the following: Fatal; life-threatening; persistent/significantly disabling/incapacitating; inpatient hospitalization/prolongation of hospitalization; significant medical incident that may jeopardize the participant and requires medical/surgical intervention to prevent one of the above outcomes

Additional Information

Aleksandra E. Zgierska, MD, PhD

Pennsylvania State University

Phone: 717-531-8187

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place