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

Chronic Pain research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Pain

Pain

Widespread Chronic Pain

Chronic Pain Syndrome

Chronic Pain Due to Injury

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Pain EdA 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.

Behavioral:CBT for 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.

Other:Usual CareA 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 Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Pain EdPain 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 PainCognitive-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 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.

Study Status

Completed

Start Date: September 12, 2013

Completed Date: December 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Brief Pain Inventory-Intensity (BPI-Intensity)

Secondary Outcome: Brief Pain Inventory-Interference (BPI-Interference)

Study sponsors, principal investigator, and references

Principal Investigator: Beverly E. Thorn, Ph.D.

Lead Sponsor: University of Alabama, Tuscaloosa

Collaborator: Patient-Centered Outcomes Research Institute

More information:https://clinicaltrials.gov/show/NCT01967342

Thorn BE, Day MA, Burns J, Kuhajda MC, Gaskins SW, Sweeney K, McConley R, Ward LC, 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):2710-20. doi: 10.1016/j.pain.2011.07.007. Epub 2011 Sep 14.

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