Please select the eligibility criteria that correspond to the clinical trial below.
Title: Reducing Disparities With Literacy-Adapted Psychosocial Treatments for Chronic Pain: A Comparative Trial
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).


Options:
A: Inclusion Criteria:

* a patient must have been diagnosed with FM according to diagnostic criteria of the American College of Rheumatology
* being 18 years or older and
* having had continuous chronic pain for at least 6 months.

Exclusion Criteria:

* Patients were excluded if they did not agree to participate in the study,
* were suffering from a severe psychiatric or organic disorder, or
* were involved in employment-related legal proceedings related to their FM. Participants in the trial were required to sign an informed consent form.
B: 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.
C: Inclusion Criteria:

1. Working age up to and including 59 years.
2. Sick-listed full-time for BNP for at least 42 days and at most 730 days.
3. Able to manage tolerably well to fill in forms.

Exclusion Criteria:

1. Temporary disability pension or disability pension being paid or in preparation.
2. A primary need of action by a hospital specialist.
3. Pregnancy and diseases which would probably make rehabilitation impracticable (for example, advanced pulmonary disease).
4. Whiplash-associated disorders as a primary obstacle to working.
5. Previous rehabilitation at the rehabilitation centre.
6. Other multidisciplinary rehabilitation going on or planned.
D: Inclusion Criteria:

* Chronic back pain (daily pain for \> 6 months)

Exclusion Criteria:

* Major medical conditions which might contraindicate antidepressant treatment

Answer: B