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

Not Applicable

Completed

Conditions: Pain
Widespread Chronic Pain
Chronic Pain Syndrome
Chronic Pain Due to Injury
Chronic Pain

Interventions: Behavioral: CBT for Pain
Behavioral: Pain Ed
Other: Usual Care

Registration Number: NCT01967342

Lead Sponsor: University of Alabama, Tuscaloosa

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).

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:

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 290

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Ed	Usual Care	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.
CBT for Pain	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.
Pain Ed	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.
CBT for Pain	Usual Care	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.
Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory-Intensity (BPI-Intensity)	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.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC), Pain Intensity	Retrospective self-report at post-treatment (10-weeks) and follow-up (6-months).	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).
Brief Pain Inventory-Interference (BPI-Interference)	Post-treatment (10-weeks) and follow-up (6 months)	Brief Pain Inventory-Intensity indicates level of pain interference. Higher scores (range 0-10) reflect higher perceived pain interference.
Patient Health Questionnaire - 9 (PHQ-9)	Post-treatment (10-weeks) and follow-up (6 months)	Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9; range 0-27; higher scores indicate greater severity).

Trial Locations

Locations (3): University of Alabama, Department of Psychology
🇺🇸
Tuscaloosa, Alabama, United States
Whatley Health Services, Inc.
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Tuscaloosa, Alabama, United States
East Carolina University
🇺🇸
Greenville, North Carolina, United States