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