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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Web-based CBT for chronic pain

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Mount Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: treatment-as-usual (TAU); The standard medical treatment provided to chronic pain patients at the study site pain specialty practice
Experimental: 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	Behavioral: 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; Other Names: cognitive behavior therapy (CBT); web-based intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pain severity, as measured by the Multidimensional Pain Inventory (MPI)	6 months
pain interference, 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

Outcome Measure	Time Frame
pain catastrophizing, measured by the Pain Catastrophizing Scale (PCS)	6 months
Emergency Department visits for pain	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Activities, Social Activities, Activities Away from Home, Household Chores	activity sub-scales of the Multidimensional Pain Inventory (MPI)	6 months
psychiatric distress, assessed via the SCL-10R		6 months
positive affect, assessed by the Positive Affect Negative Affect Scale (PANAS)		6 months
quality of life, as measured by the World Health Organization Quality of Life-BREF		6 months
social support, assessed by the MOS Social Support Scale		6 months
expectations about the future, assessed by the Future Scale		6 months

Collaborators and Investigators

• Sponsor: National Development and Research Institutes, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); Beth Israel Medical Center
• Investigators: Principal Investigator: Lisa A. Marsch, Ph.D., Dartmouth College

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: December 21, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimate): December 23, 2011

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: chronic pain; cognitive behavior therapy; web-based intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: WebCBTPain618; R01DA026887 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED