Chronic PainLAMPNCT01967342
Literacy-Adapted Psychosocial Treatments for Chronic Pain --- "Learning About Mastering/My Pain"
A study testing Pain Ed and CBT for Pain in people with Chronic Pain and Pain, run by University of Alabama, Tuscaloosa at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Pain, Pain, Widespread Chronic Pain
- What is being tested?
- Pain Ed and CBT for Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Sep 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be at least 19 yrs-old in order to consent to treatment.
- Must have received at least one diagnosis consistent with chronic pain by a physician at one of the participating primary care clinics.
- 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).
- Must be able to speak and understand English.
- Must have a telephone or other avenue of communication for contact regarding the study.
Who cannot join
- Must not demonstrate significant cognitive impairment (based on results of a cognitive screener).
- 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).
- Must have minimal literacy skills (i.e., read at the 1st grade level).
- Must have been stabilized for at least 4 weeks on current pain and psychotropic medication regimen to reduce potential confounds to treatment results.
- Must not have a surgery scheduled for the intervention period (~3 months).
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
East Carolina University
Greenville, North Carolina, 27858
Whatley Health Services, Inc.
Tuscaloosa, Alabama, 35401
University of Alabama, Department of Psychology
Tuscaloosa, Alabama, 35487-0348
About this study
Official title: Reducing Disparities With Literacy-Adapted Psychosocial Treatments for Chronic Pain: A Comparative Trial
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.
Read more
Our research questions:
- 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?
- 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).
Read the 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:
- 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?
- 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:
- Evaluate the feasibility, acceptability, and comparative effectiveness of health literacy-adapted psychosocial group treatments to a standard-treatment control.
- 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
- Chronic Pain, Pain, Widespread Chronic Pain, Chronic Pain Syndrome, Chronic Pain Due to Injury
- Being tested
- Pain Ed, CBT for Pain, Usual Care
- 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
- Medical subject headings
- Chronic Pain, Pain, Back Pain, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain EdBehavioural
Also called EDU, Pain Education, Group Pain Education, Chronic Pain Education
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 PainBehavioural
Also called Cognitive-Behavioral Therapy for Pain, Group CBT for Pain, Group Cognitive-Behavioral Therapy for Pain, CBT for Chronic 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 CareOther
Also called UC, Standard Care, Treatment as Usual, TAU
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain Ed | Experimental | 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. Receives: Behavioral: Pain Ed; Other: Usual Care |
| CBT for Pain | Experimental | 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. Receives: Behavioral: CBT for Pain; Other: Usual Care |
| Usual Care | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-treatment (10-weeks) and follow-up (6 months)
Secondary outcomes (3)
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.
Measured: Post-treatment (10-weeks) and follow-up (6 months)
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).
Measured: Post-treatment (10-weeks) and follow-up (6 months)
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).
Measured: Retrospective self-report at post-treatment (10-weeks) and follow-up (6-months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study start12 Sep 2013
- Primary completionFeb 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Whatley Health Services, East Carolina University
- Responsible party
- Sponsor
- Investigators
- Beverly E. Thorn, Ph.D., Principal investigator, University of Alabama at BirminghamJoshua C. Eyer, Ph.D., Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967342
- Sponsor's protocol ID
- 10-021-ME
- Other IDs
- Easygrants 941
- Acronym
- LAMP
- Status last verified
- Mar 2017
- First submitted
- 16 Oct 2013
- Last updated
- 21 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The complete data set may be obtained by request from the PI. The dataset will be available in November.
Publications
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.
PubMed 21920668Day 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.
PubMed 21839689Kuhajda 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.
PubMed 24073046Day 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.
PubMed 20817401Campbell 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.
PubMed 21963312Thorn 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.
PubMed 21227586Burns 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.
PubMed 34448755Newman 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.
PubMed 34252906Morais 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.
PubMed 34004347Newman 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.
PubMed 32603873Van 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.
PubMed 31022555Newman 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.
PubMed 29905879Thorn 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.
PubMed 29482213Newman 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.
PubMed 28570481
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Disparities With Literacy-Adapted Psychosocial Treatments for Chronic Pain: A Comparative Trial
- ClinicalTrials.gov ID
- NCT01967342
- Acronym / sponsor ID
- LAMP / 10-021-ME
- Conditions
- Chronic Pain, Pain, Widespread Chronic Pain, Chronic Pain Syndrome, Chronic Pain Due to Injury
- Keywords
- chronic pain, pain, chronic pain syndrome, widespread chronic pain, back pain, literacy, health literacy, group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Whatley Health Services, East Carolina University
- Study start
- 12 Sep 2013 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Posted 7 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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:
- 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?
- 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:
- Evaluate the feasibility, acceptability, and comparative effectiveness of health literacy-adapted psychosocial group treatments to a standard-treatment control.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pain Ed | Experimental | Behavioral: Pain Ed, Other: Usual CarePain 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. |
| CBT for Pain | Experimental | Behavioral: CBT for Pain, Other: Usual CareCognitive-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. |
| Usual Care | Active comparator | Other: Usual CareUsual 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be at least 19 yrs-old in order to consent to treatment.
- Must have received at least one diagnosis consistent with chronic pain by a physician at one of the participating primary care clinics.
- 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).
- Must be able to speak and understand English.
- Must have a telephone or other avenue of communication for contact regarding the study.
Key exclusion criteria (6 listed)
- Must not demonstrate significant cognitive impairment (based on results of a cognitive screener).
- 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).
- Must have minimal literacy skills (i.e., read at the 1st grade level).
- Must have been stabilized for at least 4 weeks on current pain and psychotropic medication regimen to reduce potential confounds to treatment results.
- Must not have a surgery scheduled for the intervention period (~3 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain EdAlso: EDU, Pain Education, Group Pain Education, Chronic Pain EducationA 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. | Behavioural | Pain Ed |
| CBT for PainAlso: Cognitive-Behavioral Therapy for Pain, Group CBT for Pain, Group Cognitive-Behavioral Therapy for Pain, CBT for Chronic PainA 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. | Behavioural | CBT for Pain |
| Usual CareAlso: UC, Standard Care, Treatment as Usual, TAUA 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 | CBT for Pain, Pain Ed, Usual Care |
Primary outcome
Brief Pain Inventory-Intensity (BPI-Intensity)
Time frame: 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.
3 secondary outcomes
Brief Pain Inventory-Interference (BPI-Interference)
Time frame: Post-treatment (10-weeks) and follow-up (6 months)
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: Post-treatment (10-weeks) and follow-up (6 months)
Patient Global Impression of Change (PGIC), Pain Intensity
Time frame: Retrospective self-report at post-treatment (10-weeks) and follow-up (6-months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21920668Thorn 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.
- Background: PubMed 21839689Day 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.
- Background: PubMed 24073046Kuhajda 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.
- Background: PubMed 20817401Day 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.
- Background: PubMed 21963312Campbell 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.
- Background: PubMed 21227586Thorn 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.
- Derived from this study: PubMed 34448755Burns 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.
- Derived from this study: PubMed 34252906Newman 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.
- Derived from this study: PubMed 34004347Morais 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.
- Derived from this study: PubMed 32603873Newman 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.
- Derived from this study: PubMed 31022555Van 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.
- Derived from this study: PubMed 29905879Newman 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.
- The Thorn Pain Management Team Web SiteLink provided by the sponsor.
- Whatley Health Services, Inc.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The complete data set may be obtained by request from the PI. The dataset will be available in November.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly E. Thorn, Ph.D. principal investigator
University of Alabama at Birmingham
Joshua C. Eyer, Ph.D. study director
University of Alabama at Birmingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Ed and CBT for Pain in people with Chronic Pain and Pain, run by University of Alabama, Tuscaloosa at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory-Intensity (BPI-Intensity) (time frame: Post-treatment (10-weeks) and follow-up (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01967342, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.