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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Web-based CBT for chronic pain

• Registration Number: NCT01498510
• Lead Sponsor: National Development and Research Institutes, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Study Start: 2012-02
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• moderate-to-severe pain for at least 3 months (score of 5 or greater on Brief Pain Inventory)
• patient at pain treatment program study site
• prescribed opioid analgesics
• aberrant drug-related behavior within the past 30 days (endorsing 4 or more items on the Current Opioid Misuse Measure)

Exclusion Criteria

• primary headache or cancer pain
• scheduled for major surgery within the next 6 months
• described by physician as likely to die within the next year
• plans to move out of the area within the next 3 months
• insufficient ability to provide informed consent or insufficient English to participate in consent process, assessments or computer intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU plus web-based intervention	Web-based CBT for chronic pain	An interactive, web-based intervention, based on principles of cognitive behavior therapy (CBT), that teaches chronic pain patients with aberrant behavior self-management skills to reduce pain severity and medication misuse and improve functioning

Primary Outcome Measures

Name	Time	Method
pain interference, as measured by the Multidimensional Pain Inventory (MPI)	6 months
pain severity, as measured by the Multidimensional Pain Inventory (MPI)	6 months
aberrant drug-related behavior, assessed via the Current Opioid Misuse Measure (COMM)	6 months

Secondary Outcome Measures

Name	Time	Method
Emergency Department visits for pain	6 months
pain catastrophizing, measured by the Pain Catastrophizing Scale (PCS)	6 months

Trial Locations

Locations (1)

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States