- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01498510
Web-based Cognitive-behavior Therapy (CBT) for Opioid-treated, Chronic Pain Patients With Aberrant Behavior (WebCBTPain)
May 23, 2017 updated by: National Development and Research Institutes, Inc.
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Mount Sinai Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain severity, as measured by the Multidimensional Pain Inventory (MPI)
Time Frame: 6 months
|
6 months
|
pain interference, as measured by the Multidimensional Pain Inventory (MPI)
Time Frame: 6 months
|
6 months
|
aberrant drug-related behavior, assessed via the Current Opioid Misuse Measure (COMM)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain catastrophizing, measured by the Pain Catastrophizing Scale (PCS)
Time Frame: 6 months
|
6 months
|
Emergency Department visits for pain
Time Frame: 6 months
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Activities, Social Activities, Activities Away from Home, Household Chores
Time Frame: 6 months
|
activity sub-scales of the Multidimensional Pain Inventory (MPI)
|
6 months
|
psychiatric distress, assessed via the SCL-10R
Time Frame: 6 months
|
6 months
|
|
positive affect, assessed by the Positive Affect Negative Affect Scale (PANAS)
Time Frame: 6 months
|
6 months
|
|
quality of life, as measured by the World Health Organization Quality of Life-BREF
Time Frame: 6 months
|
6 months
|
|
social support, assessed by the MOS Social Support Scale
Time Frame: 6 months
|
6 months
|
|
expectations about the future, assessed by the Future Scale
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lisa A. Marsch, Ph.D., Dartmouth College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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