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

NCT01967342 | Completed Results DMC

• 2 other identifiers: 10-021-MEEasygrants 941
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 3

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. 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. 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?

Conditions

Chronic Pain; Pain; Widespread Chronic Pain; Chronic Pain Syndrome; Chronic Pain Due to Injury

Keywords

chronic pain; pain; chronic pain syndrome; widespread chronic pain; back pain; literacy; health literacy; group therapy; psychosocial treatment; cognitive-behavioral therapy; pain education; health disparities; patient-centered outcomes

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory-Intensity (BPI-Intensity)

  Brief Pain Inventory-Intensity indicates level of pain intensity. Higher scores (range 0-10) reflect higher perceived pain severity.

  Post-treatment (10-weeks) and follow-up (6 months)

Secondary Outcomes (3)

• Brief Pain Inventory-Interference (BPI-Interference)

  Post-treatment (10-weeks) and follow-up (6 months)

• Patient Health Questionnaire - 9 (PHQ-9)

  Post-treatment (10-weeks) and follow-up (6 months)

• Patient Global Impression of Change (PGIC), Pain Intensity

  Retrospective self-report at post-treatment (10-weeks) and follow-up (6-months).

Study Arms (3)

Pain Ed

EXPERIMENTAL

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.

Behavioral: Pain Ed; Other: Usual Care

CBT for Pain

EXPERIMENTAL

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.

Behavioral: CBT for Pain; Other: Usual Care

Usual Care

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: EDU, Pain Education, Group Pain Education, Chronic Pain Education, Group Chronic Pain Education

Pain Ed

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.

Also known as: 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

CBT for 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.

Also known as: UC, Standard Care, Treatment as Usual, TAU, Medical Treatment as Usual

CBT for Pain; Pain Ed; Usual Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Whatley Health Services: collaborator
• East Carolina University: collaborator

Study Sites (3)

Whatley Health Services, Inc.

Tuscaloosa, Alabama, 35401, United States

Location

University of Alabama, Department of Psychology

Tuscaloosa, Alabama, 35487-0348, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Related Publications (14)

• Thorn BE, Day MA, Burns J, Kuhajda MC, Gaskins SW, Sweeney K, McConley R, Ward CL, Cabbil C. Randomized trial of group cognitive behavioral therapy compared with a pain education control for low-literacy rural people with chronic pain. Pain. 2011 Dec;152(12):2710-2720. doi: 10.1016/j.pain.2011.07.007. Epub 2011 Sep 14.

  PMID: 21920668 BACKGROUND

• Day MA, Thorn BE, Kapoor S. A qualitative analysis of a randomized controlled trial comparing a cognitive-behavioral treatment with education. J Pain. 2011 Sep;12(9):941-52. doi: 10.1016/j.jpain.2011.02.354. Epub 2011 Aug 11.

  PMID: 21839689 BACKGROUND

• Kuhajda MC, Thorn BE, Gaskins SW, Day MA, Cabbil CM. Literacy and cultural adaptations for cognitive behavioral therapy in a rural pain population. Transl Behav Med. 2011 Jun;1(2):216-23. doi: 10.1007/s13142-011-0026-2.

  PMID: 24073046 BACKGROUND

• Day MA, Thorn BE. The relationship of demographic and psychosocial variables to pain-related outcomes in a rural chronic pain population. Pain. 2010 Nov;151(2):467-474. doi: 10.1016/j.pain.2010.08.015.

  PMID: 20817401 BACKGROUND

• Campbell LC. Addressing literacy as a barrier in delivery and evaluation of cognitive-behavioral therapy for pain management. Pain. 2011 Dec;152(12):2679-2680. doi: 10.1016/j.pain.2011.09.004. Epub 2011 Sep 29. No abstract available.

  PMID: 21963312 BACKGROUND

• Thorn BE, Burns JW. Common and specific treatment mechanisms in psychosocial pain interventions: the need for a new research agenda. Pain. 2011 Apr;152(4):705-706. doi: 10.1016/j.pain.2010.12.017. Epub 2011 Jan 11. No abstract available.

  PMID: 21227586 BACKGROUND

• Burns JW, Gerhart J, Van Dyke BP, Morais CA, Newman AK, Thorn B. Examination of mechanism effects in cognitive behavioral therapy and pain education: analyses of weekly assessments. Pain. 2021 Sep 1;162(9):2446-2455. doi: 10.1097/j.pain.0000000000002237.

  PMID: 34448755 DERIVED

• Newman AK, Thorn BE. Intersectional identity approach to chronic pain disparities using latent class analysis. Pain. 2022 Apr 1;163(4):e547-e556. doi: 10.1097/j.pain.0000000000002407.

  PMID: 34252906 DERIVED

• Morais CA, Newman AK, Van Dyke BP, Thorn B. The Effect of Literacy-Adapted Psychosocial Treatments on Biomedical and Biopsychosocial Pain Conceptualization. J Pain. 2021 Nov;22(11):1396-1407. doi: 10.1016/j.jpain.2021.04.005. Epub 2021 May 15.

  PMID: 34004347 DERIVED

• Newman AK, Morais CA, Van Dyke BP, Thorn BE. An Initial Psychometric Evaluation of the Pain Concepts Questionnaire in a Low-SES Setting. J Pain. 2021 Jan;22(1):57-67. doi: 10.1016/j.jpain.2020.05.002. Epub 2020 Jun 27.

  PMID: 32603873 DERIVED

• Van Dyke BP, Newman AK, Morais CA, Burns JW, Eyer JC, Thorn BE. Heterogeneity of Treatment Effects in a Randomized Trial of Literacy-Adapted Group Cognitive-Behavioral Therapy, Pain Psychoeducation, and Usual Medical Care for Multiply Disadvantaged Patients With Chronic Pain. J Pain. 2019 Oct;20(10):1236-1248. doi: 10.1016/j.jpain.2019.04.006. Epub 2019 Apr 22.

  PMID: 31022555 DERIVED

• Newman AK, Kapoor S, Thorn BE. Health Care Utilization for Chronic Pain in Low-Income Settings. Pain Med. 2018 Dec 1;19(12):2387-2397. doi: 10.1093/pm/pny119.

  PMID: 29905879 DERIVED

• Thorn BE, Eyer JC, Van Dyke BP, Torres CA, Burns JW, Kim M, Newman AK, Campbell LC, Anderson B, Block PR, Bobrow BJ, Brooks R, Burton TT, Cheavens JS, DeMonte CM, DeMonte WD, Edwards CS, Jeong M, Mulla MM, Penn T, Smith LJ, Tucker DH. Literacy-Adapted Cognitive Behavioral Therapy Versus Education for Chronic Pain at Low-Income Clinics: A Randomized Controlled Trial. Ann Intern Med. 2018 Apr 3;168(7):471-480. doi: 10.7326/M17-0972. Epub 2018 Feb 27.

  PMID: 29482213 DERIVED

• Newman AK, Van Dyke BP, Torres CA, Baxter JW, Eyer JC, Kapoor S, Thorn BE. The relationship of sociodemographic and psychological variables with chronic pain variables in a low-income population. Pain. 2017 Sep;158(9):1687-1696. doi: 10.1097/j.pain.0000000000000964.

  PMID: 28570481 DERIVED

Related Links

• The Thorn Pain Management Team Web Site
• Whatley Health Services, Inc.

MeSH Terms

Conditions

Chronic Pain; Pain; Back Pain; Literacy

Interventions

Cognitive Behavioral Therapy; Standard of Care; Therapeutics

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Beverly E. Thorn, Ph.D.
• Organization: University of Alabama

bthorn@ua.edu

(205) 348-8024

Study Officials

• Beverly E. Thorn, Ph.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Joshua C. Eyer, Ph.D.

  University of Alabama at Birmingham

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 22, 2013
• Study Start: September 12, 2013
• Primary Completion: February 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 21, 2017
• Results First Posted: March 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (3)