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

Chronic Pain Clinical Trial

— WebCBTPain  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498510
• Other study ID #: WebCBTPain618
• Secondary ID: R01DA026887
• Status: Completed
• Phase: N/A
• First received: December 21, 2011
• Last updated: May 23, 2017
• Start date: February 2012
• Est. completion date: January 2015

Study information

• Verified date: May 2017
• Source: National Development and Research Institutes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
National Development and Research Institutes, Inc.	Beth Israel Medical Center, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General Activities, Social Activities, Activities Away from Home, Household Chores	activity sub-scales of the Multidimensional Pain Inventory (MPI)	6 months
Other	psychiatric distress, assessed via the SCL-10R		6 months
Other	positive affect, assessed by the Positive Affect Negative Affect Scale (PANAS)		6 months
Other	quality of life, as measured by the World Health Organization Quality of Life-BREF		6 months
Other	social support, assessed by the MOS Social Support Scale		6 months
Other	expectations about the future, assessed by the Future Scale		6 months
Primary	pain severity, as measured by the Multidimensional Pain Inventory (MPI)		6 months
Primary	pain interference, as measured by the Multidimensional Pain Inventory (MPI)		6 months
Primary	aberrant drug-related behavior, assessed via the Current Opioid Misuse Measure (COMM)		6 months
Secondary	pain catastrophizing, measured by the Pain Catastrophizing Scale (PCS)		6 months
Secondary	Emergency Department visits for pain		6 months