LAMP: Literacy-Adapted Psychosocial Treatments for Chronic Pain --- "Learning About Mastering/My Pain"

• Sponsor: University of Alabama, Tuscaloosa (Other)
• Overall Status: Completed
• CT.gov ID: NCT01967342
• Collaborator: Patient-Centered Outcomes Research Institute (Other), Whatley Health Services (Other), East Carolina University (Other)
• Enrollment: 290
• Locations: 3
• Arms: 3
• Actual Duration (Months): 38.6
• Patients Per Site: 96.7
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

Chronic pain is a significant public health problem that affects over 116 million Americans, costs $600 billion annually, and is unequally borne by people in low-income brackets, especially ethnic minorities. Many individuals also have health literacy deficits (difficulty understanding their illness and difficulty navigating the health care system for treatment) putting them at a greater disadvantage. Treatment usually relies on expensive medical interventions that often have negative side-effects. Psychosocial treatments, like Pain Education and Cognitive-Behavioral Therapy (CBT), show promise, but are usually unavailable. Clinicians are poorly equipped to provide psychosocial treatments to patients with low health literacy. CBT has not been adapted and supported for use in individuals with low health literacy, and even educational materials are often poorly adapted for their needs.

To address this problem, the PI completed a small trial showing benefits from health literacy-adapted pain education and CBT groups for chronic pain in a population with low income and low health literacy. Patients in both treatments reported lower pain by the end of treatment, and the effects were maintained at one year. Patients in the CBT group also reported less depression. The current study uses a larger sample, and directly compares these psychosocial treatments to medical treatment-as-usual to seek better evidence for or against their widespread use in community settings.

Our research questions:

1. In people with chronic pain and low income and/or low literacy, does participating in a health-literacy-adapted psychosocial treatment improve their pain and interference in daily activities due to pain by the end of treatment when compared with a group receiving typical medical care, and are these effects maintained 6 months later?

2. Does participation in the CBT pain management group improve symptoms of depression better than a pain education group by the end of treatment, and are these effects maintained 6 months later?

In partnership with a federally qualified health center, we will enroll 294 patients with chronic pain. Main outcomes will be patient-reported pain intensity, pain interference, depression, and perceived change. From an earlier trial, we expect that our participants will be ~75% female and ~70% African American, and will have low literacy and low income (~60% in the low 15% nationally on word reading, and 90% at or below the poverty threshold).

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Pain; Widespread Chronic Pain; Chronic Pain Syndrome; Chronic Pain Due to Injury	Behavioral: Pain Ed; Behavioral: CBT for Pain; Other: Usual Care	N/A

Detailed Description

Study Description

Chronic pain is a major public health problem that is compounded by a number of health-related disparities. Low health literacy presents a notable access barrier to effective treatment as it produces cumulative education and communication deficits. Standard care employs biomedical approaches that are expensive, often invasive, and limited in accessibility and long-term effectiveness. Psychosocial treatments are efficacious, yet few psychosocial interventions have adequately addressed the significant health literacy barriers that exclude a substantial portion of disadvantaged individuals from the benefits of treatment.

Research Questions:

1. In individuals with chronic pain and low socioeconomic standing who are receiving care at a federally qualified health center in the Southern US, does participating in a health-literacy-adapted psychosocial treatment group improve their self-reported pain intensity and interference in physical functioning by the end of treatment when compared with a group receiving standard medical care, and are these effects maintained 6 months later?

2. In these same individuals, does participation in the CBT pain management group improve depressive symptoms better than a pain education group by the end of treatment, and are these effects maintained 6 months later? The proposed study will build on researcher experience developing and evaluating psychosocial treatments for chronic pain in individuals with low socioeconomic standing (SES) and on strong partnerships with community health centers to evaluate two innovative, health-literacy-adapted psychosocial interventions for chronic pain. Both interventions integrate patient feedback, expert opinion, and qualitative patient data.

DESIGN

We propose a three-group, community-based randomized, controlled, comparative effectiveness trial. Participants will be patients receiving care from a federally qualified primary care clinic. Patients are expected to be mostly ethnic minority females living below the poverty line with significant unmet need for chronic pain treatment. Patients will be randomly assigned by group to a standard medical treatment control, a pain education group, or a cognitive-behavioral therapy group. Primary outcomes are patient-reported pain intensity, pain interference in physical functioning, and psychological symptoms, all highly relevant to patient-provider decision-making.

Aims:

1. Evaluate the feasibility, acceptability, and comparative effectiveness of health literacy-adapted psychosocial group treatments to a standard-treatment control.

2. Evaluate the comparative effectiveness of treatment groups on depressive symptoms, and evaluate all outcomes for heterogeneity of treatment effects.

STUDY IMPACT

• Systems: Produces a new, low-cost treatment option for community health clinics.

• Providers: Offers options for treatments over and above surgery and medication.

• Patients: Provides information to patients on the benefits of psychosocial treatment on outcomes that matter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 290 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Reducing Disparities With Literacy-Adapted Psychosocial Treatments for Chronic Pain: A Comparative Trial
• Actual Study Start Date: Sep 12, 2013
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pain Ed Pain Education: A psychosocial treatment group focusing on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. This condition also included medical treatment as usual.	Behavioral: Pain Ed; A 10-week psychosocial group treatment for chronic pain that focuses on providing information about the development, course, and treatment of chronic pain, as well as information about factors associated with reduced pain (e.g., sleep). In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system.; Other Names: EDU Pain Education Group Pain Education Chronic Pain Education Group Chronic Pain Education ; Other: Usual Care; A comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy. However, cost has a pragmatic influence on the amount of services provided, sought, and received.; Other Names: UC Standard Care Treatment as Usual TAU Medical Treatment as Usual
Experimental: CBT for Pain Cognitive-Behavioral Therapy for Pain: A psychosocial treatment group focusing on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. This condition also included medical treatment as usual.	Behavioral: CBT for Pain; A 10-week psychosocial group treatment for chronic pain that focuses on providing information and skills about the development, course, and treatment of chronic pain, as well as information about factors associated with reduced pain (e.g., sleep). In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system.; Other Names: Cognitive-Behavioral Therapy for Pain Group CBT for Pain Group Cognitive-Behavioral Therapy for Pain CBT for Chronic Pain Group CBT for Chronic Pain Cognitive-Behavioral Therapy for Chronic Pain Group Cognitive-Behavioral Therapy for Chronic Pain ; Other: Usual Care; A comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy. However, cost has a pragmatic influence on the amount of services provided, sought, and received.; Other Names: UC Standard Care Treatment as Usual TAU Medical Treatment as Usual
Active Comparator: Usual Care Usual Care (Medical Treatment-as-Usual: A control/comparison condition in which patients receive on-going standard care at the federally qualified health center partnering in this research. Facets of care may include medication, surgery, chiropractic, and physical therapy, among others, which are available to all patients in all arms.	Other: Usual Care; A comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy. However, cost has a pragmatic influence on the amount of services provided, sought, and received.; Other Names: UC Standard Care Treatment as Usual TAU Medical Treatment as Usual

Outcome Measures

Primary Outcome Measures

1. Brief Pain Inventory-Intensity (BPI-Intensity) [Post-treatment (10-weeks) and follow-up (6 months)]

   Brief Pain Inventory-Intensity indicates level of pain intensity. Higher scores (range 0-10) reflect higher perceived pain severity.

Secondary Outcome Measures

1. Brief Pain Inventory-Interference (BPI-Interference) [Post-treatment (10-weeks) and follow-up (6 months)]

   Brief Pain Inventory-Intensity indicates level of pain interference. Higher scores (range 0-10) reflect higher perceived pain interference.

2. Patient Health Questionnaire - 9 (PHQ-9) [Post-treatment (10-weeks) and follow-up (6 months)]

   Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9; range 0-27; higher scores indicate greater severity).

3. Patient Global Impression of Change (PGIC), Pain Intensity [Retrospective self-report at post-treatment (10-weeks) and follow-up (6-months).]

   The Patient Global Impression of Change (PGIC) assesses self-perceived changes in pain intensity. Scores were dichotomized such that responses of "very much better" and "much better" were recoded as 1 and all other responses were coded as zero, as performed by Cherkin et al. (2016), in order to indicate clinically meaningful improvement on pain intensity. The following outcome measure data table reports the number of participants per group reporting clinically meaningful improvement at post-treatment (10-weeks) and follow-up (6-months).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Must be at least 19 yrs-old in order to consent to treatment.

2. Must have received at least one diagnosis consistent with chronic pain by a physician at one of the participating primary care clinics.

3. Must have experienced pain most days of the month for 3 months, and although pain may have more than one pain source, all pain must be non-malignant (e.g., not cancer- or HIV-related).

4. Must be able to speak and understand English.

5. Must have a telephone or other avenue of communication for contact regarding the study.

Exclusion Criteria:

1. Must not demonstrate significant cognitive impairment (based on results of a cognitive screener).

2. Must not have current, uncontrolled serious psychological disturbance (e.g., schizophrenia, bipolar disorder) or active substance abuse (based on responses to a structured diagnostic interview).

3. Must have minimal literacy skills (i.e., read at the 1st grade level).

4. Must have been stabilized for at least 4 weeks on current pain and psychotropic medication regimen to reduce potential confounds to treatment results.

5. Must not have a surgery scheduled for the intervention period (~3 months).

6. Must neither be currently receiving a psychosocial treatment for pain (though they may be receiving psychotherapy for non-pain difficulties) nor be a participant in our previous treatment studies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Whatley Health Services, Inc.	Tuscaloosa	Alabama	United States	35401
2	University of Alabama, Department of Psychology	Tuscaloosa	Alabama	United States	35487-0348
3	East Carolina University	Greenville	North Carolina	United States	27858

Sponsors and Collaborators

• University of Alabama, Tuscaloosa
• Patient-Centered Outcomes Research Institute
• Whatley Health Services
• East Carolina University

Investigators

• Principal Investigator: Beverly E. Thorn, Ph.D., University of Alabama at Birmingham
• Study Director: Joshua C. Eyer, Ph.D., University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The Thorn Pain Management Team Web Site
• Whatley Health Services, Inc.

Publications

• Campbell LC. Addressing literacy as a barrier in delivery and evaluation of cognitive-behavioral therapy for pain management. Pain. 2011 Dec;152(12):2679-2680. doi: 10.1016/j.pain.2011.09.004. Epub 2011 Sep 29.
• Day MA, Thorn BE, Kapoor S. A qualitative analysis of a randomized controlled trial comparing a cognitive-behavioral treatment with education. J Pain. 2011 Sep;12(9):941-52. doi: 10.1016/j.jpain.2011.02.354. Epub 2011 Aug 11.
• Day MA, Thorn BE. The relationship of demographic and psychosocial variables to pain-related outcomes in a rural chronic pain population. Pain. 2010 Nov;151(2):467-474. doi: 10.1016/j.pain.2010.08.015.
• Kuhajda MC, Thorn BE, Gaskins SW, Day MA, Cabbil CM. Literacy and cultural adaptations for cognitive behavioral therapy in a rural pain population. Transl Behav Med. 2011 Jun;1(2):216-23. doi: 10.1007/s13142-011-0026-2.
• Thorn BE, Burns JW. Common and specific treatment mechanisms in psychosocial pain interventions: the need for a new research agenda. Pain. 2011 Apr;152(4):705-706. doi: 10.1016/j.pain.2010.12.017. Epub 2011 Jan 11.
• Thorn BE, Day MA, Burns J, Kuhajda MC, Gaskins SW, Sweeney K, McConley R, Ward CL, Cabbil C. Randomized trial of group cognitive behavioral therapy compared with a pain education control for low-literacy rural people with chronic pain. Pain. 2011 Dec;152(12):2710-2720. doi: 10.1016/j.pain.2011.07.007. Epub 2011 Sep 14.

• Responsible Party: University of Alabama, Tuscaloosa
• ClinicalTrials.gov Identifier: NCT01967342
• Other Study ID Numbers: 10-021-ME; Easygrants 941
• First Posted: Oct 22, 2013
• Last Update Posted: Jun 21, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by University of Alabama, Tuscaloosa: chronic pain; pain; chronic pain syndrome; widespread chronic pain; back pain; literacy; health literacy; group therapy; psychosocial treatment; cognitive-behavioral therapy; pain education; health disparities; patient-centered outcomes
• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Arm/Group Title	Usual Care	CBT for Pain	Pain Ed
Arm/Group Description	Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
Period Title: Overall Study
STARTED	98	95	97
5-week Follow-up	83	78	76
10-week Follow-up	78	83	80
COMPLETED	71	70	68
NOT COMPLETED	27	25	29

Baseline Characteristics

Arm/Group Title	Usual Care	CBT for Pain	Pain Ed	Total
Arm/Group Description	Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Total of all reporting groups
Overall Participants	98	95	97	290
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	96 98%	90 94.7%	93 95.9%	279 96.2%
>=65 years	2 2%	5 5.3%	4 4.1%	11 3.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.7 (8.7)	52.2 (8.5)	49.9 (9.2)	50.6 (8.9)
Sex: Female, Male (Count of Participants)
Female	69 70.4%	67 70.5%	69 71.1%	205 70.7%
Male	29 29.6%	28 29.5%	28 28.9%	85 29.3%
Race/Ethnicity, Customized (Count of Participants)
Black/African-American	60 61.2%	75 78.9%	59 60.8%	194 66.9%
White/Caucasian	38 38.8%	20 21.1%	38 39.2%	96 33.1%
Brief Pain Inventory (BPI) Severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.5 (1.6)	6.5 (1.8)	6.5 (1.5)	6.5 (1.6)
Brief Pain Inventory (BPI) Interference (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.6 (2.1)	6.7 (2.1)	6.6 (1.9)	6.6 (2.0)
Patient Health Questionnaire-9 items (PHQ-9) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	12.8 (6.4)	11.7 (6.1)	11.9 (6.8)	12.1 (6.4)

Outcome Measures

1. Primary Outcome

Title	Brief Pain Inventory-Intensity (BPI-Intensity)
Description	Brief Pain Inventory-Intensity indicates level of pain intensity. Higher scores (range 0-10) reflect higher perceived pain severity.
Time Frame	Post-treatment (10-weeks) and follow-up (6 months)

Outcome Measure Data

Analysis Population Description

The predicted mean estimates were based on latent growth modeling from mplus using all participants.

Arm/Group Title	Usual Care	CBT for Pain	Pain Ed
Arm/Group Description	Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
Measure Participants	78	82	80
Post-treatment (10-weeks)	6.19 (1.81)	5.42 (2.29)	5.68 (2.04)
Follow-up (6-months)	5.95 (1.84)	5.82 (2.22)	5.97 (1.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care
	Comments	A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between pre-treatment and 10-week post-treatment.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.165
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.268
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: -0.193
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care
	Comments	A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between post-treatment and 6-month follow-up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.216
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.245
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.198
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CBT for Pain
	Comments	A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the pre-treatment and 10-week post-treatment.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< .001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.052
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.189
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	CBT for Pain
	Comments	A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the post-treatment and 6-month follow-up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.070
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.361
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.199
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pain Ed
	Comments	A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the pre-treatment and 10-week post-treatment.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< .001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.823
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.191
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pain Ed
	Comments	A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the post-treatment and 6-month follow-up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.519
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.131
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.203
	Estimation Comments

2. Secondary Outcome

Title	Brief Pain Inventory-Interference (BPI-Interference)
Description	Brief Pain Inventory-Intensity indicates level of pain interference. Higher scores (range 0-10) reflect higher perceived pain interference.
Time Frame	Post-treatment (10-weeks) and follow-up (6 months)

Outcome Measure Data

Analysis Population Description

The predicted mean estimates were based on latent growth modeling from mplus using all participants.

Arm/Group Title	Usual Care	CBT for Pain	Pain Ed
Arm/Group Description	Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
Measure Participants	78	83	80
10-week post-treatment	6.11 (2.52)	5.01 (2.73)	5.46 (2.43)
6-month follow-up	6.32 (2.18)	5.55 (2.75)	5.98 (2.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care
	Comments	A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the pre-treatment and 10-week post-treatment.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.196
	Comments	To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.310
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.247
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care
	Comments	A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the post-treatment and 6-month follow-up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.447
	Comments	To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.182
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.239
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CBT for Pain
	Comments	A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the pre-treatment and 10-week post-treatment.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.643
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.241
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	CBT for Pain
	Comments	A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the post-treatment and 6-month follow-up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.021
	Comments	To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.548
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.237
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pain Ed
	Comments	A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the pre-treatment and 10-week post-treatment.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< .001
	Comments	To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.999
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.244
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pain Ed
	Comments	A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the post-treatment and 6-month follow-up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.305
	Comments	To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.250
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.243
	Estimation Comments

3. Secondary Outcome

Title	Patient Health Questionnaire - 9 (PHQ-9)
Description	Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9; range 0-27; higher scores indicate greater severity).
Time Frame	Post-treatment (10-weeks) and follow-up (6 months)

Outcome Measure Data

Analysis Population Description

The predicted mean estimates were based on latent growth modeling from mplus using all participants.

Arm/Group Title	Usual Care	CBT for Pain	Pain Ed
Arm/Group Description	Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
Measure Participants	78	83	80
Post-treatment (10-weeks)	11.42 (6.56)	9.13 (5.77)	9.59 (6.12)
Follow-up (6-months)	11.58 (7.09)	9.73 (6.70)	10.53 (6.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care
	Comments	A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the pre-treatment and 10-week post-treatment.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.082
	Comments	To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.086
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.623
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care
	Comments	A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the post-treatment and 6-month follow-up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.652
	Comments	To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.240
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.532
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CBT for Pain
	Comments	A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the pre-treatment and 10-week post-treatment.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< .001
	Comments	To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.416
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.612
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	CBT for Pain
	Comments	A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the post-treatment and 6-month follow-up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.241
	Comments	To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.619
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.528
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pain Ed
	Comments	A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the pre-treatment and 10-week post-treatment.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< .001
	Comments	To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.251
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.617
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pain Ed
	Comments	A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the post-treatment and 6-month follow-up.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.422
	Comments	To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.434
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.541
	Estimation Comments

4. Secondary Outcome

Title	Patient Global Impression of Change (PGIC), Pain Intensity
Description	The Patient Global Impression of Change (PGIC) assesses self-perceived changes in pain intensity. Scores were dichotomized such that responses of "very much better" and "much better" were recoded as 1 and all other responses were coded as zero, as performed by Cherkin et al. (2016), in order to indicate clinically meaningful improvement on pain intensity. The following outcome measure data table reports the number of participants per group reporting clinically meaningful improvement at post-treatment (10-weeks) and follow-up (6-months).
Time Frame	Retrospective self-report at post-treatment (10-weeks) and follow-up (6-months).

Outcome Measure Data

Analysis Population Description

Only participants who completed the post-treatment (10-weeks) and follow-up (6-months) assessments were included in the following analyses.

Arm/Group Title	Usual Care	CBT for Pain	Pain Ed
Arm/Group Description	Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.	Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.	Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
Measure Participants	78	82	80
Post-treatment (10-weeks)	6 6.1%	33 34.7%	23 23.7%
Follow-up (6-months)	6 6.1%	19 20%	22 22.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, CBT for Pain
	Comments	Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (6-months).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	8.45
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	CBT vs. TAU

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Pain Ed
	Comments	Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (10-weeks).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	5.53
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	EDU vs. TAU

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CBT for Pain, Pain Ed
	Comments	Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at pre-treatment (10-weeks).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.217
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.53
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	CBT vs. EDU

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Usual Care, CBT for Pain
	Comments	Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.009
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.81
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	CBT vs. TAU

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Pain Ed
	Comments	Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	5.32
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	EDU vs. TAU

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	CBT for Pain, Pain Ed
	Comments	Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.389
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	CBT vs. EDU

Adverse Events

Time Frame	2 years, 11 months and 4 days.
Adverse Event Reporting Description	Participants completed four assessments over the course of the study. Assessors asked about adverse events at these assessments, using a safety alert form prepared for the trial. Participants in the CBT and EDU conditions also completed weekly measures at the time of the weekly meeting over the 10-week class, and were asked about adverse events on a weekly basis. For each safety alert/adverse event, participants were asked whether it was related to being in the study.
Arm/Group Title	Usual Care		CBT for Pain		Pain Ed
Arm/Group Description	Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.		Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.		Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
All Cause Mortality
	Usual Care		CBT for Pain		Pain Ed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Usual Care		CBT for Pain		Pain Ed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/98 (3.1%)		1/95 (1.1%)		2/97 (2.1%)
Gastrointestinal disorders
Abdominal Pain	0/98 (0%)	0	0/95 (0%)	0	1/97 (1%)	1
Intestinal Infection	0/98 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0
General disorders
Unknown reason for hospitalization	1/98 (1%)	1	0/95 (0%)	0	0/97 (0%)	0
Musculoskeletal and connective tissue disorders
Gout flare on right knee and foot	1/98 (1%)	1	0/95 (0%)	0	0/97 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation	1/98 (1%)	1	0/95 (0%)	0	0/97 (0%)	0
Surgical and medical procedures
Female organ surgery	0/98 (0%)	0	0/95 (0%)	0	1/97 (1%)	1
Other (Not Including Serious) Adverse Events
	Usual Care		CBT for Pain		Pain Ed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/98 (12.2%)		4/95 (4.2%)		14/97 (14.4%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain exacerbation	12/98 (12.2%)		4/95 (4.2%)		14/97 (14.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.