Literacy-Adapted Psychosocial Treatments for Chronic Pain --- "Learning About Mastering/My Pain"
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain, Chronic Pain, Hospital, Psychiatric |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | August 2016 |
Reducing Disparities With Literacy-Adapted Psychosocial Treatments for Chronic Pain: A Comparative Trial
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).
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).
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.
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.
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.
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