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CompletedNCT01967342LAMPUpdated Jun 21, 2017Results posted

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

An interventional study of Pain Ed and CBT for Pain in Chronic Pain, Pain and Widespread Chronic Pain, sponsored by University of Alabama, Tuscaloosa. Completed at 3 sites in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-06-21.

Sponsored by University of Alabama, Tuscaloosa · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
290
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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).

Read the 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.
02

Conditions studied

  • 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
03

In context

Chronic Pain

2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.

This study's enrollment of 290 is above the median of 60 across 2,209 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

University of Alabama, Tuscaloosa is the lead sponsor of 42 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
290 participants (actual)

Study arms

  • 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. This condition also included medical treatment as usual.

    Behavioral: Pain Ed · Other: Usual Care

  • 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. This condition also included medical treatment as usual.

    Behavioral: CBT for Pain · Other: Usual Care

  • 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

Interventions

  • BehavioralPain 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.

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

  • BehavioralCBT 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.

    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

  • OtherUsual 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.

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

06

What researchers measure

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.

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

Secondary outcomes

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

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

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

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

    Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9; range 0-27; higher scores indicate greater severity).

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

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

    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).

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

07

Results

Posted Mar 7, 2017

Participant flow

Participant flow — Overall Study
MilestoneUsual CareCBT for PainPain Ed
Started989597
5-week follow-up837876
10-week follow-up788380
Completed717068
Not completed272529

Outcome measures

PrimaryBrief Pain Inventory-Intensity (BPI-Intensity)

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

Time frame:
Post-treatment (10-weeks) and follow-up (6 months)
Reported as:
Mean · units on a scale
Brief Pain Inventory-Intensity (BPI-Intensity)
units on a scaleUsual CareCBT for PainPain Ed
Post-treatment (10-weeks)6.19 ± 1.815.42 ± 2.295.68 ± 2.04
Follow-up (6-months)5.95 ± 1.845.82 ± 2.225.97 ± 1.99
Statistical analysis
  • Usual Care · Mixed Models Analysis · p = .165 · Mean difference (net): -0.268
  • Usual Care · Mixed Models Analysis · p = .216 · Mean difference (net): -0.245
  • CBT for Pain · Mixed Models Analysis · p = < .001 · Mean difference (net): -1.052
  • CBT for Pain · Mixed Models Analysis · p = .070 · Mean difference (net): 0.361
  • Pain Ed · Mixed Models Analysis · p = < .001 · Mean difference (net): -0.823
  • Pain Ed · Mixed Models Analysis · p = .519 · Mean difference (net): 0.131
SecondaryBrief Pain Inventory-Interference (BPI-Interference)

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

Time frame:
Post-treatment (10-weeks) and follow-up (6 months)
Reported as:
Mean · units on a scale
Brief Pain Inventory-Interference (BPI-Interference)
units on a scaleUsual CareCBT for PainPain Ed
10-week post-treatment6.11 ± 2.525.01 ± 2.735.46 ± 2.43
6-month follow-up6.32 ± 2.185.55 ± 2.755.98 ± 2.36
Statistical analysis
  • Usual Care · Mixed Models Analysis · p = .196 (To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.) · Mean difference (net): -0.310
  • Usual Care · Mixed Models Analysis · p = .447 (To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.) · Mean difference (net): 0.182
  • CBT for Pain · Mixed Models Analysis · p = <.001 (To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.) · Mean difference (net): -1.643
  • CBT for Pain · Mixed Models Analysis · p = .021 (To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.) · Mean difference (net): 0.548
  • Pain Ed · Mixed Models Analysis · p = < .001 (To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.) · Mean difference (net): -0.999
  • Pain Ed · Mixed Models Analysis · p = .305 (To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.) · Mean difference (net): 0.250
SecondaryPatient Health Questionnaire - 9 (PHQ-9)

Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9; range 0-27; higher scores indicate greater severity).

Time frame:
Post-treatment (10-weeks) and follow-up (6 months)
Reported as:
Mean · units on a scale
Patient Health Questionnaire - 9 (PHQ-9)
units on a scaleUsual CareCBT for PainPain Ed
Post-treatment (10-weeks)11.42 ± 6.569.13 ± 5.779.59 ± 6.12
Follow-up (6-months)11.58 ± 7.099.73 ± 6.7010.53 ± 6.35
Statistical analysis
  • Usual Care · Mixed Models Analysis · p = .082 (To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.) · Mean difference (net): -1.086
  • Usual Care · Mixed Models Analysis · p = .652 (To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.) · Mean difference (net): -0.240
  • CBT for Pain · Mixed Models Analysis · p = < .001 (To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.) · Mean difference (net): -2.416
  • CBT for Pain · Mixed Models Analysis · p = .241 (To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.) · Mean difference (net): 0.619
  • Pain Ed · Mixed Models Analysis · p = < .001 (To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.) · Mean difference (net): -2.251
  • Pain Ed · Mixed Models Analysis · p = .422 (To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.) · Mean difference (net): 0.434
SecondaryPatient Global Impression of Change (PGIC), Pain Intensity

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).

Time frame:
Retrospective self-report at post-treatment (10-weeks) and follow-up (6-months).
Reported as:
Count of participants · Participants
Patient Global Impression of Change (PGIC), Pain Intensity
ParticipantsUsual CareCBT for PainPain Ed
Post-treatment (10-weeks)63323
Follow-up (6-months)61922
Statistical analysis
  • Usual Care vs CBT for Pain · Mixed Models Analysis · p = <.001 · Odds ratio (or): 8.45CBT vs. TAU
  • Usual Care vs Pain Ed · Mixed Models Analysis · p = .001 · Odds ratio (or): 5.53EDU vs. TAU
  • CBT for Pain vs Pain Ed · Mixed Models Analysis · p = .217 · Odds ratio (or): 1.53CBT vs. EDU
  • Usual Care vs CBT for Pain · Mixed Models Analysis · p = .009 · Odds ratio (or): 3.81CBT vs. TAU
  • Usual Care vs Pain Ed · Mixed Models Analysis · p = .001 · Odds ratio (or): 5.32EDU vs. TAU
  • CBT for Pain vs Pain Ed · Mixed Models Analysis · p = .389 · Odds ratio (or): 0.72CBT vs. EDU

Adverse events

Collected over 2 years, 11 months and 4 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Usual Care—3/98 (3.1%)12/98 (12.2%)
CBT for Pain—1/95 (1.1%)4/95 (4.2%)
Pain Ed—2/97 (2.1%)14/97 (14.4%)
Most frequent serious events
Most frequent serious events
EventUsual CareCBT for PainPain Ed
Intestinal InfectionGastrointestinal disorders0/981/950/97
Abdominal PainGastrointestinal disorders0/980/951/97
Female organ surgerySurgical and medical procedures0/980/951/97
Asthma ExacerbationRespiratory, thoracic and mediastinal disorders1/980/950/97
Gout flare on right knee and footMusculoskeletal and connective tissue disorders1/980/950/97
Unknown reason for hospitalizationGeneral disorders1/980/950/97
Most frequent other events
Most frequent other events
EventUsual CareCBT for PainPain Ed
Musculoskeletal pain exacerbationMusculoskeletal and connective tissue disorders12/984/9514/97

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Usual CareCBT for PainPain EdTotal
<=18 years0000
Between 18 and 65 years969093279
>=65 years25411
Age, Continuous
Age, Continuous(years)Usual CareCBT for PainPain EdTotal
Mean49.7 ± 8.752.2 ± 8.549.9 ± 9.250.6 ± 8.9
Sex: Female, Male
Sex: Female, Male(Participants)Usual CareCBT for PainPain EdTotal
Female696769205
Male29282885
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Usual CareCBT for PainPain EdTotal
Black/African-American607559194
White/Caucasian38203896
Brief Pain Inventory (BPI) Severity
Brief Pain Inventory (BPI) Severity(units on a scale)Usual CareCBT for PainPain EdTotal
Mean6.5 ± 1.66.5 ± 1.86.5 ± 1.56.5 ± 1.6
Brief Pain Inventory (BPI) Interference
Brief Pain Inventory (BPI) Interference(units on a scale)Usual CareCBT for PainPain EdTotal
Mean6.6 ± 2.16.7 ± 2.16.6 ± 1.96.6 ± 2.0
Patient Health Questionnaire-9 items (PHQ-9)
Patient Health Questionnaire-9 items (PHQ-9)(units on a scale)Usual CareCBT for PainPain EdTotal
Mean12.8 ± 6.411.7 ± 6.111.9 ± 6.812.1 ± 6.4
08

Study locations

3 sites
  • Whatley Health Services, Inc.
    Tuscaloosa, Alabama 35401, United States
  • University of Alabama, Department of Psychology
    Tuscaloosa, Alabama 35487-0348, United States
  • East Carolina University
    Greenville, North Carolina 27858, United States
09

References and documents

Publications

  • 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. PubMed 21920668 ↗
  • 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. PubMed 21839689 ↗
  • 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. PubMed 24073046 ↗
  • 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. PubMed 20817401 ↗
  • 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. PubMed 21963312 ↗
  • 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. PubMed 21227586 ↗
  • 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. PubMed 34448755 ↗
  • 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. PubMed 34252906 ↗
  • 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. PubMed 34004347 ↗
  • 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. PubMed 32603873 ↗
  • 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. PubMed 31022555 ↗
  • 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. PubMed 29905879 ↗
  • 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. PubMed 29482213 ↗
  • 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. PubMed 28570481 ↗

Individual participant data

Plan to share: Yes — The complete data set may be obtained by request from the PI. The dataset will be available in November.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2013 to primary completion in Feb 2016, 29 months.

Results were first posted in Mar 2017, 1 year 1 month after primary completion.

Of 1,209 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 29 months is above that.

Counting every sponsor, half of 1,296 studies reached it within 21 months; a quarter within 9 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2013
First posted
Oct 22, 2013
StartActual
Sep 12, 2013
Primary completionActual
Feb 2016
CompletionActual
Dec 2016
Results first posted
Mar 7, 2017
Last update
Jun 21, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01967342
Lead sponsor
University of Alabama, Tuscaloosa
Collaborators
Patient-Centered Outcomes Research Institute, Whatley Health Services, East Carolina University
Responsible party
Sponsor
First posted
Oct 22, 2013
Start date
Sep 12, 2013
Primary completion
Feb 2016
Completion
Dec 2016
Results posted
Mar 7, 2017
Last update
Jun 21, 2017

Study contacts

Beverly E. Thorn, Ph.D.
principal investigator · University of Alabama at Birmingham
Joshua C. Eyer, Ph.D.
study director · University of Alabama at Birmingham

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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