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Completed

NCT Number: NCT01967342

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).

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Key information

Conditions

Chronic Pain Back Pain Behavior Chronic Pain Due to Injury Chronic Pain Syndrome Communication Literacy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Widespread Chronic Pain

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Department of Psychology, Tuscaloosa, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain Ed

Behavioral

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.

Other names: EDU, Pain Education, Group Pain Education, Chronic Pain Education, Group Chronic Pain Education

CBT for Pain

Behavioral

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.

Other names: Cognitive-Behavioral Therapy for Pain, Group CBT for Pain, Group Cognitive-Behavioral Therapy for Pain, CBT for Chronic Pain, Group CBT for Chronic Pain, Cognitive-Behavioral Therapy for Chronic Pain, Group Cognitive-Behavioral Therapy for Chronic Pain

Usual Care

Other

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.

Other names: UC, Standard Care, Treatment as Usual, TAU, Medical Treatment as Usual

Primary outcomes

  1. 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.

Secondary outcomes

  1. Brief Pain Inventory-Interference (BPI-Interference)

    Time frame: 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.

  2. Patient Health Questionnaire - 9 (PHQ-9)

    Time frame: 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).

  3. Patient Global Impression of Change (PGIC), Pain Intensity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Alabama, Tuscaloosa

Other

Collaborators

  • East Carolina University
  • Patient-Centered Outcomes Research Institute
  • Whatley Health Services

Registry information

Official study title

Reducing Disparities With Literacy-Adapted Psychosocial Treatments for Chronic Pain: A Comparative Trial

Acronym: LAMP

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 22, 2013
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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