Mount Sinai Medical Center
New York, 10003, United States
NCT Number: NCT01498510
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
New York, 10003, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
activity sub-scales of the Multidimensional Pain Inventory (MPI)
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
National Development and Research Institutes, Inc.
Other
Web-based CBT for Opioid-treated, Chronic Pain Patients With Aberrant Behavior
Acronym: WebCBTPain
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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