Literacy-Adapted Psychosocial Treatments for Chronic Pain --- "Learning About Mastering/My Pain"
NCT ID: NCT01967342
Last Updated: 2017-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
290 participants
INTERVENTIONAL
2013-09-12
2016-12-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Whatley Health Services
UNKNOWN
East Carolina University
OTHER
University of Alabama, Tuscaloosa
OTHER
Responsible Party
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Principal Investigators
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Beverly E. Thorn, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Joshua C. Eyer, Ph.D.
Role: STUDY_DIRECTOR
University of Alabama at Birmingham
Locations
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Whatley Health Services, Inc.
Tuscaloosa, Alabama, United States
University of Alabama, Department of Psychology
Tuscaloosa, Alabama, United States
East Carolina University
Greenville, North Carolina, United States
Countries
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References
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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.
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.
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.
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.
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. No abstract available.
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. No abstract available.
Burns JW, Gerhart J, Van Dyke BP, Morais CA, Newman AK, Thorn B. Examination of mechanism effects in cognitive behavioral therapy and pain education: analyses of weekly assessments. Pain. 2021 Sep 1;162(9):2446-2455. doi: 10.1097/j.pain.0000000000002237.
Newman AK, Thorn BE. Intersectional identity approach to chronic pain disparities using latent class analysis. Pain. 2022 Apr 1;163(4):e547-e556. doi: 10.1097/j.pain.0000000000002407.
Morais CA, Newman AK, Van Dyke BP, Thorn B. The Effect of Literacy-Adapted Psychosocial Treatments on Biomedical and Biopsychosocial Pain Conceptualization. J Pain. 2021 Nov;22(11):1396-1407. doi: 10.1016/j.jpain.2021.04.005. Epub 2021 May 15.
Newman AK, Morais CA, Van Dyke BP, Thorn BE. An Initial Psychometric Evaluation of the Pain Concepts Questionnaire in a Low-SES Setting. J Pain. 2021 Jan;22(1):57-67. doi: 10.1016/j.jpain.2020.05.002. Epub 2020 Jun 27.
Van Dyke BP, Newman AK, Morais CA, Burns JW, Eyer JC, Thorn BE. Heterogeneity of Treatment Effects in a Randomized Trial of Literacy-Adapted Group Cognitive-Behavioral Therapy, Pain Psychoeducation, and Usual Medical Care for Multiply Disadvantaged Patients With Chronic Pain. J Pain. 2019 Oct;20(10):1236-1248. doi: 10.1016/j.jpain.2019.04.006. Epub 2019 Apr 22.
Newman AK, Kapoor S, Thorn BE. Health Care Utilization for Chronic Pain in Low-Income Settings. Pain Med. 2018 Dec 1;19(12):2387-2397. doi: 10.1093/pm/pny119.
Thorn BE, Eyer JC, Van Dyke BP, Torres CA, Burns JW, Kim M, Newman AK, Campbell LC, Anderson B, Block PR, Bobrow BJ, Brooks R, Burton TT, Cheavens JS, DeMonte CM, DeMonte WD, Edwards CS, Jeong M, Mulla MM, Penn T, Smith LJ, Tucker DH. Literacy-Adapted Cognitive Behavioral Therapy Versus Education for Chronic Pain at Low-Income Clinics: A Randomized Controlled Trial. Ann Intern Med. 2018 Apr 3;168(7):471-480. doi: 10.7326/M17-0972. Epub 2018 Feb 27.
Newman AK, Van Dyke BP, Torres CA, Baxter JW, Eyer JC, Kapoor S, Thorn BE. The relationship of sociodemographic and psychological variables with chronic pain variables in a low-income population. Pain. 2017 Sep;158(9):1687-1696. doi: 10.1097/j.pain.0000000000000964.
Related Links
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The Thorn Pain Management Team Web Site
Whatley Health Services, Inc.
Other Identifiers
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Easygrants 941
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
10-021-ME
Identifier Type: -
Identifier Source: org_study_id
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