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NCT01967342 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of Alabama, Tuscaloosa.

Completed
Registry status
NA
Development phase
290
Enrollment target

NCT01967342: Completed NA study, sponsored by University of Alabama, Tuscaloosa.

NCT01967342 is a NA study that has completed, run by University of Alabama, Tuscaloosa. The registered enrollment target is 290 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01967342, a NA study, has completed, sponsored by University of Alabama, Tuscaloosa.

COMPLETED
Registry status
NA
Development phase
290 participants
Enrollment target

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 ar

Primary Outcome

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

Interventions

  • OTHER Usual Care
  • BEHAVIORAL Pain Ed
  • BEHAVIORAL CBT for Pain

Trial Details

FieldValue
Enrollment Target 290 participants
Start Date 2013-09-12
Est. Completion 2016-12
Phase NA
University of Alabama, Tuscaloosa

13 total trials

What the finished NCT01967342 record still lists

NCT01967342 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 3 interventions - of which Usual Care is the first listed.

NCT01967342 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01967342 about?

NCT01967342 is a clinical study titled "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...

What is the current status of trial NCT01967342?

This trial is currently completed. It is a NA study. The enrollment target is 290 participants. The study started on 2013-09-12. Estimated completion is 2016-12.

What interventions are being tested in trial NCT01967342?

The interventions under investigation include: Usual Care (OTHER), Pain Ed (BEHAVIORAL), CBT for Pain (BEHAVIORAL).

Who is sponsoring clinical trial NCT01967342?

This trial is sponsored by University of Alabama, Tuscaloosa, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01967342's enrollment target sits among peer trials

290 375th of 2000 higher than 1,625 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01967342, the US trial registry maintained by the National Library of Medicine. NCT01967342 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.