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

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Beth Israel Medical Center
Information provided by (Responsible Party):
National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier:
NCT01498510
First received: December 21, 2011
Last updated: May 23, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Chronic Pain Behavioral: Web-based CBT for chronic pain

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Web-based CBT for Opioid-treated, Chronic Pain Patients With Aberrant Behavior

Resource links provided by NLM:


Further study details as provided by National Development and Research Institutes, Inc.:

Primary Outcome Measures:
  • pain severity, as measured by the Multidimensional Pain Inventory (MPI) [ Time Frame: 6 months ]
  • pain interference, as measured by the Multidimensional Pain Inventory (MPI) [ Time Frame: 6 months ]
  • aberrant drug-related behavior, assessed via the Current Opioid Misuse Measure (COMM) [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • pain catastrophizing, measured by the Pain Catastrophizing Scale (PCS) [ Time Frame: 6 months ]
  • Emergency Department visits for pain [ Time Frame: 6 months ]

Other Outcome Measures:
  • General Activities, Social Activities, Activities Away from Home, Household Chores [ Time Frame: 6 months ]
    activity sub-scales of the Multidimensional Pain Inventory (MPI)

  • psychiatric distress, assessed via the SCL-10R [ Time Frame: 6 months ]
  • positive affect, assessed by the Positive Affect Negative Affect Scale (PANAS) [ Time Frame: 6 months ]
  • quality of life, as measured by the World Health Organization Quality of Life-BREF [ Time Frame: 6 months ]
  • social support, assessed by the MOS Social Support Scale [ Time Frame: 6 months ]
  • expectations about the future, assessed by the Future Scale [ Time Frame: 6 months ]

Enrollment: 110
Study Start Date: February 2012
Study Completion Date: January 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498510

Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
National Development and Research Institutes, Inc.
National Institute on Drug Abuse (NIDA)
Beth Israel Medical Center
Investigators
Principal Investigator: Andrew Rosenblum, Ph.D. National Development and Research Institutes, Inc.
Principal Investigator: Lisa A. Marsch, Ph.D. Dartmouth College
  More Information

Responsible Party: National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier: NCT01498510     History of Changes
Other Study ID Numbers: WebCBTPain618
R01DA026887 ( U.S. NIH Grant/Contract )
Study First Received: December 21, 2011
Last Updated: May 23, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by National Development and Research Institutes, Inc.:
chronic pain
cognitive behavior therapy
web-based intervention

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 20, 2017