Web-based Cognitive-behavior Therapy (CBT) for Opioid-treated, Chronic Pain Patients With Aberrant Behavior (WebCBTPain)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based CBT for chronic pain
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, cognitive behavior therapy, 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
Sites / Locations
- Mount Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
treatment-as-usual (TAU)
TAU plus web-based intervention
Arm Description
The standard medical treatment provided to chronic pain patients at the study site pain specialty practice
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
Outcomes
Primary Outcome Measures
pain severity, as measured by the Multidimensional Pain Inventory (MPI)
pain interference, as measured by the Multidimensional Pain Inventory (MPI)
aberrant drug-related behavior, assessed via the Current Opioid Misuse Measure (COMM)
Secondary Outcome Measures
pain catastrophizing, measured by the Pain Catastrophizing Scale (PCS)
Emergency Department visits for pain
Full Information
NCT ID
NCT01498510
First Posted
December 21, 2011
Last Updated
May 23, 2017
Sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), Beth Israel Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01498510
Brief Title
Web-based Cognitive-behavior Therapy (CBT) for Opioid-treated, Chronic Pain Patients With Aberrant Behavior
Acronym
WebCBTPain
Official Title
Web-based CBT for Opioid-treated, Chronic Pain Patients With Aberrant Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), Beth Israel Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, cognitive behavior therapy, web-based intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment-as-usual (TAU)
Arm Type
No Intervention
Arm Description
The standard medical treatment provided to chronic pain patients at the study site pain specialty practice
Arm Title
TAU plus web-based intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Web-based CBT for chronic pain
Other Intervention Name(s)
cognitive behavior therapy (CBT), web-based intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
pain severity, as measured by the Multidimensional Pain Inventory (MPI)
Time Frame
6 months
Title
pain interference, as measured by the Multidimensional Pain Inventory (MPI)
Time Frame
6 months
Title
aberrant drug-related behavior, assessed via the Current Opioid Misuse Measure (COMM)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
pain catastrophizing, measured by the Pain Catastrophizing Scale (PCS)
Time Frame
6 months
Title
Emergency Department visits for pain
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
General Activities, Social Activities, Activities Away from Home, Household Chores
Description
activity sub-scales of the Multidimensional Pain Inventory (MPI)
Time Frame
6 months
Title
psychiatric distress, assessed via the SCL-10R
Time Frame
6 months
Title
positive affect, assessed by the Positive Affect Negative Affect Scale (PANAS)
Time Frame
6 months
Title
quality of life, as measured by the World Health Organization Quality of Life-BREF
Time Frame
6 months
Title
social support, assessed by the MOS Social Support Scale
Time Frame
6 months
Title
expectations about the future, assessed by the Future Scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Rosenblum, Ph.D.
Organizational Affiliation
National Development and Research Institutes, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa A. Marsch, Ph.D.
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Web-based Cognitive-behavior Therapy (CBT) for Opioid-treated, Chronic Pain Patients With Aberrant Behavior
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