Trial record 1 of 218 for:    Open Studies | "Chronic Pain"
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Alabama, Tuscaloosa
Sponsor:
Collaborators:
Patient Centered Outcome Research Institute
Whatley Health Services
East Carolina University
Information provided by (Responsible Party):
University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier:
NCT01967342
First received: October 16, 2013
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention
Chronic Pain
Pain
Widespread Chronic Pain
Chronic Pain Syndrome
Chronic Pain Due to Injury
Behavioral: Pain Ed
Behavioral: CBT for Pain
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Disparities With Literacy-Adapted Psychosocial Treatments for Chronic Pain: A Comparative Trial

Resource links provided by NLM:


Further study details as provided by University of Alabama, Tuscaloosa:

Primary Outcome Measures:
  • Brief Pain Inventory-Intensity (BPI-Intensity) [ Time Frame: Change from baseline to the end of treatment (10-14 weeks) ] [ Designated as safety issue: No ]
    We intend to compare mean pre-post changes in BPI-Intensity between treatment groups and the usual care group to test for treatment effectiveness at reducing pain intensity. Using the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT) recommendations for clinically important change, a minimally important change was set at 15-20% (~1 point) and a meaningfully important change was set at 30-36% (~2 points). In addition, percentages of participants in each condition will be reported for change at the minimal, meaningful, and substantial (50% decrease or ~4 points) levels.


Secondary Outcome Measures:
  • Brief Pain Inventory-Interference (BPI-Interference) [ Time Frame: Change from baseline to the end of treatment (10-14 weeks) ] [ Designated as safety issue: No ]
    We intend to compare mean pre-post changes in BPI-Interference between treatment groups and the usual care group to test for treatment effectiveness on pain interference in daily life. Using IMMPACT recommendations for clinically important change, a minimally important change was set at 1 point.

  • Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: Change from baseline to the end of treatment (10-14 weeks) ] [ Designated as safety issue: No ]
    We will use the PHQ-9 at several key points in treatment to identify patient change in depressive symptoms. The IMMPACT publications only provided recommendations for the Beck Depression Inventory, which was deemed less satisfactory than the PHQ-9 for the current study. We will tentatively set the criterion for the minimal clinically important difference at one-half of the standard deviation of all PHQ-9 scores at the pretreatment assessment (consistent with IMMPACT practices). We reserve the right to change this metric if a reliable criterion is published in the literature prior to the data analysis period.

  • Patient Global Impression of Change (PGIC) [ Time Frame: Retrospective self-report at posttreatment (~Week 12) ] [ Designated as safety issue: No ]
    We will measure perceived change on 7 key domains of interest: (a) Pain Intensity; (b) Pain Interference; (c) Pain Acceptance; (d) Pain Coping; and (e) Negative Thoughts about Pain. For each condition, we will publish the percentages of participants endorsing each of the possible outcomes for worsening, no change, or improvement.


Estimated Enrollment: 294
Study Start Date: May 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Pain Ed
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
Other: Usual Care
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
Experimental: 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.
Behavioral: CBT for Pain
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
Other: Usual Care
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
Active Comparator: 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.
Other: Usual Care
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

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.
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967342

Contacts
Contact: Beverly E. Thorn, Ph.D. (205) 348-5024 bthorn@ua.edu
Contact: Joshua C. Eyer, Ph.D. (205) 348-2808 jceyer@ua.edu

Locations
United States, Alabama
University of Alabama, Department of Psychology Recruiting
Tuscaloosa, Alabama, United States, 35487-0348
Contact: Beverly E. Thorn, Ph.D.    205-348-5024    bthorn@ua.edu   
Contact: Joshua C. Eyer, Ph.D.    205-348-2808    jceyer@ua.edu   
Principal Investigator: Beverly E. Thorn, Ph.D.         
Sub-Investigator: Joshua C. Eyer, Ph.D.         
Whatley Health Services, Inc. Recruiting
Tuscaloosa, Alabama, United States, 35401
Contact: Toya T. Burton, D.C.    205-758-6647    tburton@whatleyhealth.org   
Principal Investigator: Toya T. Burton, D.C.         
Sub-Investigator: Deborah H. Tucker, MBA, CEO         
United States, North Carolina
East Carolina University Active, not recruiting
Greenville, North Carolina, United States, 27858
Sponsors and Collaborators
University of Alabama, Tuscaloosa
Patient Centered Outcome Research Institute
Whatley Health Services
East Carolina University
Investigators
Principal Investigator: Beverly E. Thorn, Ph.D. University of Alabama at Birmingham
Study Director: Joshua C. Eyer, Ph.D. University of Alabama at Birmingham
  More Information

Additional Information:
Publications:
Responsible Party: University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier: NCT01967342     History of Changes
Other Study ID Numbers: 10-021-ME, Easygrants 941
Study First Received: October 16, 2013
Last Updated: October 17, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by University of Alabama, Tuscaloosa:
chronic pain
chronic pain syndrome
widespread chronic pain
pain
back pain
literacy
health literacy
group therapy
psychosocial treatment
cognitive-behavioral therapy
pain education
health disparities
patient-centered outcomes

Additional relevant MeSH terms:
Somatoform Disorders
Wounds and Injuries
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014