Chronic Pain
Conditions
Keywords
opioid, taper, behavioral treatment for pain, randomized
Brief summary
The proposed study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care. This project will provide patients taking opioids and physicians with the specific evidence they need to choose the most effective route to pain control, reduced pain interference, opioid reduction, and improved role function, thereby improving patient care. The aims of this study are to (1) reduce or contain prescription opioid use while maintaining pain control and (2) compare the effectiveness of the Chronic Pain Self-Management Program (CPSMP), Cognitive Behavioral Therapy for chronic pain (pain-CBT), and no behavioral treatment within the context of patient-centered collaborative opioid tapering (Taper Only). The acronym EMPOWER stands for Effective Management of Pain and Opioid-Free Ways to Enhance Relief.
Interventions
BEHAVIORALCognitive Behavioral Therapy
A trained psychologist delivers pain-CBT to individual patients or groups of patients with chronic pain. Group treatment is delivered across 8 weekly sessions that last for 2 hours each. Pain-CBT incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session. Pain-CBT is effective for reducing pain intensity, pain catastrophizing, depression and social impacts.
BEHAVIORALChronic Pain Self Management Program
The CPSMP is similar to pain-CBT in format and content but is peer-led, and is effective across pain conditions (e.g., back pain, arthritis) for improving pain and pain self-efficacy. The CPSMP consists of six weekly 2-hour group sessions in which two peer co-leaders provide patient education about pain, effective self-management, pain impacts, and other symptoms from a highly structured manual. Similar to pain-CBT, CPSMP incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session
OTHERTaper Only
Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.
Sponsors
Stanford University
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The study manager, site coordinators, and clinicians were unblinded to group assignments, while non-clinical study investigators and statisticians remained blinded throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Chronic non-cancer pain (≥ 6 months in duration) * Currently receiving prescription opioids (≥ 10 MEDD) for ≥ 3 months
Exclusion criteria
* Unable to provide informed consent * Unable to participate in group treatments in a meaningful way (e.g., evident cognitive impairment or lack of English fluency) * Moderate to severe opioid use disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Tapering Success | Baseline and 12 months | Opioid tapering success was defined as either: 50% reduction in opioid dose (change in MEDD baseline to 12 months) and no significantly increased pain (≤ 1 point increase in PROMIS pain intensity score from baseline to 12 months), or; no opioid dose increase (baseline MEDD to 12 months) and significant pain relief (≥ 2 points decrease in PROMIS pain intensity score). Pain intensity score: Patient self-reported pain intensity on 11 point (0-10) numerical rating scale where a lower score means more pain relief. MEDD: Morphine Equivalent Daily Dose. PROMIS: Patient-Reported Outcomes Measurement Information System. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBeth Darnall, Ph.D.
Stanford University
Participant flow
Recruitment details
We partnered with seven study sites that included four outpatient primary care and Veterans health care and three pain clinics in five states (Arizona, California, Colorado, Pennsylvania, and Utah). At all sites, patient recruitment (August 2018-November 2022) was enhanced by using several methods: identifying eligibility in medical records, in-house advertising, external community-based advertising, and use of the CHOIR database at Stanford University.
Pre-assignment details
EMPOWER (opioid taper study; 3-arm randomized): 53 patients who provided consent did not complete their baseline survey; 562 participants completed their baseline survey and were randomized. VALUE (national observational study; non-randomized): 37 individuals who provided consent did not complete their baseline survey; 810 participants completed their baseline survey.
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Behavioral Therapy for Chronic Pain (Pain-CBT) A trained psychologist delivers pain-CBT to individual patients or groups of patients with chronic pain. Group treatment is delivered across 8 weekly sessions that last for 2 hours each. Pain-CBT incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session. Pain-CBT is effective for reducing pain intensity, pain catastrophizing, depression and social impacts. | 203 |
| Chronic Pain Self Management Program (CPSMP) The CPSMP is similar to pain-CBT in format and content but is peer-led, and is effective across pain conditions (e.g., back pain, arthritis) for improving pain and pain self-efficacy. The CPSMP consists of six weekly 2-hour group sessions in which two peer co-leaders provide patient education about pain, effective self-management, pain impacts, and other symptoms from a highly structured manual. Peers are people with chronic pain who live in the communities in which they teach. For this project, at least one peer facilitator per workshop will have had experience with prescription opioid use. Intervention fidelity is determined by having a trained observer with a checklist attend random workshop sessions. Similar to pain-CBT, CPSMP incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session. | 168 |
| Taper Only (Usual Care) Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention. | 191 |
| Observational Arm (the VALUE Study) Participants that do not wish to reduce their opioid medication(s) but are otherwise eligible and interested in the research study will be offered participation in the observational arm. The observational arm of the study will not include interventions of any kind and will only collect survey data for the year following consent. Data from the VALUE study will be analyzed separately from EMPOWER (randomized). | 810 |
| Total | 1,372 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Therapy for Chronic Pain (Pain-CBT) | Chronic Pain Self Management Program (CPSMP) | Taper Only (Usual Care) | Total | Observational Arm (the VALUE Study) |
|---|---|---|---|---|---|
| Age, Continuous EMPOWER Study (randomized) | 58 years STANDARD_DEVIATION 13 | 59 years STANDARD_DEVIATION 12 | 56 years STANDARD_DEVIATION 13 | 58 years STANDARD_DEVIATION 13 | — |
| Age, Continuous VALUE Study (non-randomized) | — | — | — | 54.5 years STANDARD_DEVIATION 10.8 | 54.5 years STANDARD_DEVIATION 10.8 |
| Alcohol Use Disorders Identification Test (AUDIT) EMPOWER Study (randomized) | 0.9 score on a scale STANDARD_DEVIATION 2.3 | 1.3 score on a scale STANDARD_DEVIATION 2.4 | 0.9 score on a scale STANDARD_DEVIATION 2 | 1.0 score on a scale STANDARD_DEVIATION 2.2 | — |
| Alcohol Use Disorders Identification Test (AUDIT) VALUE Study (non-randomized) | — | — | — | 1.4 score on a scale STANDARD_DEVIATION 2.1 | 1.4 score on a scale STANDARD_DEVIATION 2.1 |
| Brief Pain Inventory (BPI) - Pain Interference EMPOWER Study (randomized) | 5.9 units on a scale STANDARD_DEVIATION 2.4 | 5.8 units on a scale STANDARD_DEVIATION 2.3 | 6.1 units on a scale STANDARD_DEVIATION 2.2 | 5.9 units on a scale STANDARD_DEVIATION 2.3 | — |
| Drug Abuse Screen Test (DAST) EMPOWER Study (randomized) | 0.6 score on a scale STANDARD_DEVIATION 1.2 | 0.6 score on a scale STANDARD_DEVIATION 1.3 | 0.5 score on a scale STANDARD_DEVIATION 1.2 | 0.6 score on a scale STANDARD_DEVIATION 1.2 | — |
| Drug Abuse Screen Test (DAST) VALUE Study (non-randomized) | — | — | — | 2.1 score on a scale STANDARD_DEVIATION 1.4 | 2.1 score on a scale STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) EMPOWER Study (randomized) Hispanic or Latino | 24 Participants | 12 Participants | 22 Participants | 58 Participants | — |
| Ethnicity (NIH/OMB) EMPOWER Study (randomized) Not Hispanic or Latino | 174 Participants | 152 Participants | 159 Participants | 485 Participants | — |
| Ethnicity (NIH/OMB) EMPOWER Study (randomized) Unknown or Not Reported | 5 Participants | 4 Participants | 10 Participants | 19 Participants | — |
| Ethnicity (NIH/OMB) VALUE Study (non-randomized) Hispanic or Latino | — | — | — | 43 Participants | 43 Participants |
| Ethnicity (NIH/OMB) VALUE Study (non-randomized) Not Hispanic or Latino | — | — | — | 756 Participants | 756 Participants |
| Ethnicity (NIH/OMB) VALUE Study (non-randomized) Unknown or Not Reported | — | — | — | 11 Participants | 11 Participants |
| Morphine Equivalent Daily Dose (MEDD) EMPOWER Study (randomized) | 141.6 MEDD STANDARD_DEVIATION 280 | 123.4 MEDD STANDARD_DEVIATION 263 | 109.1 MEDD STANDARD_DEVIATION 167 | 125.1 MEDD STANDARD_DEVIATION 242 | — |
| Morphine Equivalent Daily Dose (MEDD) VALUE Study (non-randomized) | — | — | — | 116 MEDD STANDARD_DEVIATION 194 | 116 MEDD STANDARD_DEVIATION 194 |
| Pain Catastrophizing Scale EMPOWER Study (randomized) | 20.8 score on a scale STANDARD_DEVIATION 11.6 | 22.8 score on a scale STANDARD_DEVIATION 11.9 | 21.6 score on a scale STANDARD_DEVIATION 11.5 | 21.7 score on a scale STANDARD_DEVIATION 11.7 | — |
| Pain Catastrophizing Scale VALUE Study (non-randomized) | — | — | — | 32.4 score on a scale STANDARD_DEVIATION 12 | 32.4 score on a scale STANDARD_DEVIATION 12 |
| Pain Duration EMPOWER Study (randomized) 0.5 - 1 year | 1 Participants | 0 Participants | 2 Participants | 3 Participants | — |
| Pain Duration EMPOWER Study (randomized) 10 - 20 years | 76 Participants | 57 Participants | 68 Participants | 201 Participants | — |
| Pain Duration EMPOWER Study (randomized) 1 - 5 years | 24 Participants | 28 Participants | 32 Participants | 84 Participants | — |
| Pain Duration EMPOWER Study (randomized) > 20 years | 76 Participants | 57 Participants | 66 Participants | 199 Participants | — |
| Pain Duration EMPOWER Study (randomized) 6 - 10 years | 25 Participants | 26 Participants | 23 Participants | 74 Participants | — |
| Pain Duration EMPOWER Study (randomized) Unknown or not reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | — |
| Pain Duration VALUE Study (non-randomized) 0.5 - 1 year | — | — | — | 7 Participants | 7 Participants |
| Pain Duration VALUE Study (non-randomized) 10 - 20 years | — | — | — | 301 Participants | 301 Participants |
| Pain Duration VALUE Study (non-randomized) 1 - 5 years | — | — | — | 48 Participants | 48 Participants |
| Pain Duration VALUE Study (non-randomized) > 20 years | — | — | — | 302 Participants | 302 Participants |
| Pain Duration VALUE Study (non-randomized) 6 - 10 years | — | — | — | 145 Participants | 145 Participants |
| Pain Duration VALUE Study (non-randomized) Unknown or not reported | — | — | — | 7 Participants | 7 Participants |
| Pain Intensity - Average EMPOWER Study (randomized) | 6.2 units on a scale STANDARD_DEVIATION 1.9 | 6.2 units on a scale STANDARD_DEVIATION 1.9 | 6.2 units on a scale STANDARD_DEVIATION 1.9 | 6.2 units on a scale STANDARD_DEVIATION 1.9 | — |
| Pain Intensity - Average VALUE Study (non-randomized) | — | — | — | 6.1 units on a scale STANDARD_DEVIATION 1.8 | 6.1 units on a scale STANDARD_DEVIATION 1.8 |
| Pain Self-Efficacy EMPOWER Study (randomized) | 6.2 units on a scale STANDARD_DEVIATION 3.6 | 6.6 units on a scale STANDARD_DEVIATION 3.3 | 6.7 units on a scale STANDARD_DEVIATION 3.4 | 6.5 units on a scale STANDARD_DEVIATION 3.4 | — |
| Pain Self-Efficacy VALUE Study (non-randomized) | — | — | — | 5.4 units on a scale STANDARD_DEVIATION 3.4 | 5.4 units on a scale STANDARD_DEVIATION 3.4 |
| PROMIS - Anger EMPOWER Study (randomized) | 49.9 score on a scale STANDARD_DEVIATION 9.4 | 49.9 score on a scale STANDARD_DEVIATION 8.9 | 51.3 score on a scale STANDARD_DEVIATION 9 | 50.4 score on a scale STANDARD_DEVIATION 9.1 | — |
| PROMIS - Anger VALUE Study (non-randomized) | — | — | — | 49.3 score on a scale STANDARD_DEVIATION 9.3 | 49.3 score on a scale STANDARD_DEVIATION 9.3 |
| PROMIS - Anxiety EMPOWER Study (randomized) | 54.6 score on a scale STANDARD_DEVIATION 9.7 | 54.5 score on a scale STANDARD_DEVIATION 9.5 | 55.9 score on a scale STANDARD_DEVIATION 9.4 | 55.0 score on a scale STANDARD_DEVIATION 9.6 | — |
| PROMIS - Anxiety VALUE Study (non-randomized) | — | — | — | 53.0 score on a scale STANDARD_DEVIATION 9.1 | 53.0 score on a scale STANDARD_DEVIATION 9.1 |
| PROMIS - Cognitive Function EMPOWER Study (randomized) | 46.4 score on a scale STANDARD_DEVIATION 10.4 | 45.6 score on a scale STANDARD_DEVIATION 9.9 | 44.6 score on a scale STANDARD_DEVIATION 9.7 | 54.5 score on a scale STANDARD_DEVIATION 10 | — |
| PROMIS - Cognitive Function VALUE Study (non-randomized) | — | — | — | 53.2 score on a scale STANDARD_DEVIATION 10 | 53.2 score on a scale STANDARD_DEVIATION 10 |
| PROMIS - Depression EMPOWER Study (randomized) | 54.8 score on a scale STANDARD_DEVIATION 8.9 | 55.3 score on a scale STANDARD_DEVIATION 8 | 55.9 score on a scale STANDARD_DEVIATION 8.8 | 55.3 score on a scale STANDARD_DEVIATION 8.6 | — |
| PROMIS - Depression VALUE Study (non-randomized) | — | — | — | 54.6 score on a scale STANDARD_DEVIATION 8.7 | 54.6 score on a scale STANDARD_DEVIATION 8.7 |
| PROMIS - Fatigue EMPOWER Study (randomized) | 57.7 score on a scale STANDARD_DEVIATION 10 | 56.8 score on a scale STANDARD_DEVIATION 9.3 | 58.2 score on a scale STANDARD_DEVIATION 9.6 | 57.6 score on a scale STANDARD_DEVIATION 9.7 | — |
| PROMIS - Fatigue VALUE Study (non-randomized) | — | — | — | 60.3 score on a scale STANDARD_DEVIATION 9.8 | 60.3 score on a scale STANDARD_DEVIATION 9.8 |
| PROMIS - Pain Interference VALUE Study (non-randomized) | — | — | — | 68.1 score on a scale STANDARD_DEVIATION 6 | 68.1 score on a scale STANDARD_DEVIATION 6 |
| PROMIS - Physical Function EMPOWER Study (randomized) | 35.2 score on a scale STANDARD_DEVIATION 6.5 | 36.1 score on a scale STANDARD_DEVIATION 6.1 | 35.6 score on a scale STANDARD_DEVIATION 6.5 | 64.4 score on a scale STANDARD_DEVIATION 6.4 | — |
| PROMIS - Physical Function VALUE Study (non-randomized) | — | — | — | 65.4 score on a scale STANDARD_DEVIATION 5.3 | 65.4 score on a scale STANDARD_DEVIATION 5.3 |
| PROMIS - Satisfaction with Social Roles & Activities EMPOWER Study (randomized) | 40.2 score on a scale STANDARD_DEVIATION 8.1 | 41.5 score on a scale STANDARD_DEVIATION 7.5 | 39.9 score on a scale STANDARD_DEVIATION 7.7 | 59.5 score on a scale STANDARD_DEVIATION 7.8 | — |
| PROMIS - Satisfaction with Social Roles & Activities VALUE Study (non-randomized) | — | — | — | 60.4 score on a scale STANDARD_DEVIATION 7.8 | 60.4 score on a scale STANDARD_DEVIATION 7.8 |
| PROMIS - Sleep Disturbance EMPOWER Study (randomized) | 57.4 score on a scale STANDARD_DEVIATION 8.6 | 55.5 score on a scale STANDARD_DEVIATION 8.8 | 57.4 score on a scale STANDARD_DEVIATION 8.3 | 56.8 score on a scale STANDARD_DEVIATION 8.6 | — |
| PROMIS - Sleep Disturbance VALUE Study (non-randomized) | — | — | — | 57.2 score on a scale STANDARD_DEVIATION 8.5 | 57.2 score on a scale STANDARD_DEVIATION 8.5 |
| PROMIS - Social Isolation EMPOWER Study (randomized) | 47.4 score on a scale STANDARD_DEVIATION 9.5 | 48.8 score on a scale STANDARD_DEVIATION 9.3 | 48.7 score on a scale STANDARD_DEVIATION 9.7 | 48.3 score on a scale STANDARD_DEVIATION 9.5 | — |
| PROMIS - Social Isolation VALUE Study (non-randomized) | — | — | — | 48.9 score on a scale STANDARD_DEVIATION 9.3 | 48.9 score on a scale STANDARD_DEVIATION 9.3 |
| Race (NIH/OMB) EMPOWER Study (randomized) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) EMPOWER Study (randomized) Asian | 3 Participants | 4 Participants | 0 Participants | 7 Participants | — |
| Race (NIH/OMB) EMPOWER Study (randomized) Black or African American | 9 Participants | 10 Participants | 7 Participants | 26 Participants | — |
| Race (NIH/OMB) EMPOWER Study (randomized) More than one race | 14 Participants | 11 Participants | 8 Participants | 33 Participants | — |
| Race (NIH/OMB) EMPOWER Study (randomized) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) EMPOWER Study (randomized) Unknown or Not Reported | 23 Participants | 16 Participants | 26 Participants | 65 Participants | — |
| Race (NIH/OMB) EMPOWER Study (randomized) White | 154 Participants | 127 Participants | 150 Participants | 431 Participants | — |
| Race (NIH/OMB) VALUE Study (non-randomized) American Indian or Alaska Native | — | — | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) VALUE Study (non-randomized) Asian | — | — | — | 4 Participants | 4 Participants |
| Race (NIH/OMB) VALUE Study (non-randomized) Black or African American | — | — | — | 10 Participants | 10 Participants |
| Race (NIH/OMB) VALUE Study (non-randomized) More than one race | — | — | — | 38 Participants | 38 Participants |
| Race (NIH/OMB) VALUE Study (non-randomized) Native Hawaiian or Other Pacific Islander | — | — | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) VALUE Study (non-randomized) Unknown or Not Reported | — | — | — | 40 Participants | 40 Participants |
| Race (NIH/OMB) VALUE Study (non-randomized) White | — | — | — | 718 Participants | 718 Participants |
| Sex/Gender, Customized EMPOWER Study (randomized) Female | 113 Participants | 79 Participants | 104 Participants | 296 Participants | — |
| Sex/Gender, Customized EMPOWER Study (randomized) Male | 90 Participants | 89 Participants | 87 Participants | 266 Participants | — |
| Sex/Gender, Customized EMPOWER Study (randomized) Unknow or not reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Sex/Gender, Customized VALUE Study (non-randomized) Female | — | — | — | 652 Participants | 652 Participants |
| Sex/Gender, Customized VALUE Study (non-randomized) Male | — | — | — | 154 Participants | 154 Participants |
| Sex/Gender, Customized VALUE Study (non-randomized) Unknow or not reported | — | — | — | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 203 | 1 / 168 | 2 / 191 | 4 / 810 |
| other Total, other adverse events | 154 / 203 | 132 / 168 | 154 / 191 | 0 / 810 |
| serious Total, serious adverse events | 9 / 203 | 7 / 168 | 8 / 191 | 0 / 810 |
Outcome results
Primary
Opioid Tapering Success
Opioid tapering success was defined as either: 50% reduction in opioid dose (change in MEDD baseline to 12 months) and no significantly increased pain (≤ 1 point increase in PROMIS pain intensity score from baseline to 12 months), or; no opioid dose increase (baseline MEDD to 12 months) and significant pain relief (≥ 2 points decrease in PROMIS pain intensity score). Pain intensity score: Patient self-reported pain intensity on 11 point (0-10) numerical rating scale where a lower score means more pain relief. MEDD: Morphine Equivalent Daily Dose. PROMIS: Patient-Reported Outcomes Measurement Information System.
Time frame: Baseline and 12 months
Population: Data from the two studies (EMPOWER and VALUE) were analyzed separately. VALUE study did not have opioid tapering success as an outcome given that the study was observational (there was no opioid tapering implemented as part of the study); therefore, participants in the VALUE study were not assessed for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cognitive Behavioral Therapy for Chronic Pain (Pain-CBT) | Opioid Tapering Success | 86 Participants |
| Chronic Pain Self Management Program (CPSMP) | Opioid Tapering Success | 61 Participants |
| Taper Only (Usual Care) | Opioid Tapering Success | 81 Participants |
| Observational Arm (The VALUE Study) | Opioid Tapering Success | 0 Participants |