Clinical Trials Directory

Trials / Completed

CompletedNCT01498510

Web-based Cognitive-behavior Therapy (CBT) for Opioid-treated, Chronic Pain Patients With Aberrant Behavior

Web-based CBT for Opioid-treated, Chronic Pain Patients With Aberrant Behavior

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
110 (actual)
Sponsor
National Development and Research Institutes, Inc. · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to develop and evaluate an innovative, web-based self-management intervention for opioid-treated chronic pain patients who display aberrant drug-related behavior.

Detailed description

Within the past decade, there has been increasing recognition of the limitations and risks of opioid therapy for chronic pain, spurred by the U.S.' widespread epidemic of opioid misuse. Within the clinical context, concerns about long-term opioid therapy persist due to limited evidence of efficacy and the occurrence of medication misuse/abuse (termed aberrant drug-related behavior). Psychosocial approaches, particularly self-management strategies such as cognitive-behavior therapy (CBT), have been found to be efficacious for the treatment of chronic pain. However, most chronic pain patients are not exposed to comprehensive psychosocial interventions, due to factors including pain specialty physicians' lack of familiarity with and time to provide behavioral treatments and insufficient payer coverage for these therapies. To address these public health concerns, this study developed, implemented and evaluated an innovative, web-based CBT intervention for the treatment of chronic pain tailored to the specific needs of patients who are prescribed opioids and present with aberrant behavior. The development of this interactive, web-based intervention was informed by iterative feedback from pain experts and chronic pain patients. In a randomized, controlled trial, chronic pain patients receiving opioid therapy at a pain specialty practice were assigned to receive 12 weeks of either treatment-as-usual (TAU; n=55) or treatment-as-usual plus the web-based intervention (Web-CBT; n=55). The trial evaluated the relative effectiveness of these treatments on the primary outcomes of pain severity, pain interference and aberrant opioid-taking behavior, and the secondary outcomes of pain catastrophizing and pain-related Emergency Department visits. Additional analyses explored the impact of the intervention on several supplementary outcomes, such as various categories of activities, psychiatric distress and positive affect, and examined hypothesized mediators of treatment outcome, including quality of life, social support and expectations about the future.

Conditions

Interventions

TypeNameDescription
BEHAVIORALWeb-based CBT for chronic painAn interactive, web-based intervention, based on principles of cognitive behavior therapy (CBT), that is designed to train chronic pain patients in self-management skills to reduce pain and aberrant behavior and improve functioning

Timeline

Start date
2012-02-01
Primary completion
2014-12-01
Completion
2015-01-01
First posted
2011-12-23
Last updated
2017-05-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01498510. Inclusion in this directory is not an endorsement.