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

NCT ID: NCT01498510

Last Updated: 2017-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-01-31

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment-as-usual (TAU)

The standard medical treatment provided to chronic pain patients at the study site pain specialty practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

TAU plus web-based intervention

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

Group Type: EXPERIMENTAL

Web-based CBT for chronic pain

Intervention Type: BEHAVIORAL

An 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

Interventions

Web-based CBT for chronic pain

An 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

Intervention Type: BEHAVIORAL

Other Intervention Names

cognitive behavior therapy (CBT); web-based intervention

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Beth Israel Medical Center

OTHER

Sponsor Role: collaborator

National Development and Research Institutes, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Rosenblum, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Development and Research Institutes, Inc.

Lisa A. Marsch, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Locations

Mount Sinai Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

R01DA026887

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WebCBTPain618

Identifier Type: -

Identifier Source: org_study_id