Chronic Pain, Chronic Pain Due to Injury, Chronic Pain Syndrome, Pain, Widespread Chronic Pain
Conditions
Keywords
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
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).
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.
Interventions
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.
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.
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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care 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. | 98 |
| CBT for Pain 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. | 95 |
| Pain Ed 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. | 97 |
| Total | 290 |
Baseline characteristics
| Characteristic | Usual Care | CBT for Pain | Pain Ed | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 5 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants | 90 Participants | 93 Participants | 279 Participants |
| Age, Continuous | 49.7 years STANDARD_DEVIATION 8.7 | 52.2 years STANDARD_DEVIATION 8.5 | 49.9 years STANDARD_DEVIATION 9.2 | 50.6 years STANDARD_DEVIATION 8.9 |
| Brief Pain Inventory (BPI) Interference | 6.6 units on a scale STANDARD_DEVIATION 2.1 | 6.7 units on a scale STANDARD_DEVIATION 2.1 | 6.6 units on a scale STANDARD_DEVIATION 1.9 | 6.6 units on a scale STANDARD_DEVIATION 2 |
| Brief Pain Inventory (BPI) Severity | 6.5 units on a scale STANDARD_DEVIATION 1.6 | 6.5 units on a scale STANDARD_DEVIATION 1.8 | 6.5 units on a scale STANDARD_DEVIATION 1.5 | 6.5 units on a scale STANDARD_DEVIATION 1.6 |
| Patient Health Questionnaire-9 items (PHQ-9) | 12.8 units on a scale STANDARD_DEVIATION 6.4 | 11.7 units on a scale STANDARD_DEVIATION 6.1 | 11.9 units on a scale STANDARD_DEVIATION 6.8 | 12.1 units on a scale STANDARD_DEVIATION 6.4 |
| Race/Ethnicity, Customized Black/African-American | 60 Participants | 75 Participants | 59 Participants | 194 Participants |
| Race/Ethnicity, Customized White/Caucasian | 38 Participants | 20 Participants | 38 Participants | 96 Participants |
| Sex: Female, Male Female | 69 Participants | 67 Participants | 69 Participants | 205 Participants |
| Sex: Female, Male Male | 29 Participants | 28 Participants | 28 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 98 | 4 / 95 | 14 / 97 |
| serious Total, serious adverse events | 3 / 98 | 1 / 95 | 2 / 97 |
Outcome results
Brief Pain Inventory-Intensity (BPI-Intensity)
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)
Population: The predicted mean estimates were based on latent growth modeling from mplus using all participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Brief Pain Inventory-Intensity (BPI-Intensity) | Post-treatment (10-weeks) | 6.19 units on a scale | Standard Deviation 1.81 |
| Usual Care | Brief Pain Inventory-Intensity (BPI-Intensity) | Follow-up (6-months) | 5.95 units on a scale | Standard Deviation 1.84 |
| CBT for Pain | Brief Pain Inventory-Intensity (BPI-Intensity) | Post-treatment (10-weeks) | 5.42 units on a scale | Standard Deviation 2.29 |
| CBT for Pain | Brief Pain Inventory-Intensity (BPI-Intensity) | Follow-up (6-months) | 5.82 units on a scale | Standard Deviation 2.22 |
| Pain Ed | Brief Pain Inventory-Intensity (BPI-Intensity) | Follow-up (6-months) | 5.97 units on a scale | Standard Deviation 1.99 |
| Pain Ed | Brief Pain Inventory-Intensity (BPI-Intensity) | Post-treatment (10-weeks) | 5.68 units on a scale | Standard Deviation 2.04 |
Brief Pain Inventory-Interference (BPI-Interference)
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)
Population: The predicted mean estimates were based on latent growth modeling from mplus using all participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Brief Pain Inventory-Interference (BPI-Interference) | 10-week post-treatment | 6.11 units on a scale | Standard Deviation 2.52 |
| Usual Care | Brief Pain Inventory-Interference (BPI-Interference) | 6-month follow-up | 6.32 units on a scale | Standard Deviation 2.18 |
| CBT for Pain | Brief Pain Inventory-Interference (BPI-Interference) | 10-week post-treatment | 5.01 units on a scale | Standard Deviation 2.73 |
| CBT for Pain | Brief Pain Inventory-Interference (BPI-Interference) | 6-month follow-up | 5.55 units on a scale | Standard Deviation 2.75 |
| Pain Ed | Brief Pain Inventory-Interference (BPI-Interference) | 10-week post-treatment | 5.46 units on a scale | Standard Deviation 2.43 |
| Pain Ed | Brief Pain Inventory-Interference (BPI-Interference) | 6-month follow-up | 5.98 units on a scale | Standard Deviation 2.36 |
Patient Global Impression of Change (PGIC), Pain Intensity
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).
Population: Only participants who completed the post-treatment (10-weeks) and follow-up (6-months) assessments were included in the following analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Patient Global Impression of Change (PGIC), Pain Intensity | Post-treatment (10-weeks) | 6 Participants |
| Usual Care | Patient Global Impression of Change (PGIC), Pain Intensity | Follow-up (6-months) | 6 Participants |
| CBT for Pain | Patient Global Impression of Change (PGIC), Pain Intensity | Post-treatment (10-weeks) | 33 Participants |
| CBT for Pain | Patient Global Impression of Change (PGIC), Pain Intensity | Follow-up (6-months) | 19 Participants |
| Pain Ed | Patient Global Impression of Change (PGIC), Pain Intensity | Post-treatment (10-weeks) | 23 Participants |
| Pain Ed | Patient Global Impression of Change (PGIC), Pain Intensity | Follow-up (6-months) | 22 Participants |
Patient Health Questionnaire - 9 (PHQ-9)
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)
Population: The predicted mean estimates were based on latent growth modeling from mplus using all participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Patient Health Questionnaire - 9 (PHQ-9) | Post-treatment (10-weeks) | 11.42 units on a scale | Standard Deviation 6.56 |
| Usual Care | Patient Health Questionnaire - 9 (PHQ-9) | Follow-up (6-months) | 11.58 units on a scale | Standard Deviation 7.09 |
| CBT for Pain | Patient Health Questionnaire - 9 (PHQ-9) | Post-treatment (10-weeks) | 9.13 units on a scale | Standard Deviation 5.77 |
| CBT for Pain | Patient Health Questionnaire - 9 (PHQ-9) | Follow-up (6-months) | 9.73 units on a scale | Standard Deviation 6.7 |
| Pain Ed | Patient Health Questionnaire - 9 (PHQ-9) | Post-treatment (10-weeks) | 9.59 units on a scale | Standard Deviation 6.12 |
| Pain Ed | Patient Health Questionnaire - 9 (PHQ-9) | Follow-up (6-months) | 10.53 units on a scale | Standard Deviation 6.35 |