Clinical trial NCT01498510: Web-based Cognitive-behavior Therapy (CBT) for Opioid-treated, Chronic Pain Patients With Aberrant Behavior
Official title: Web-based CBT for Opioid-treated, Chronic Pain Patients With Aberrant Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
cognitive behavior therapy
web-based intervention
Lead sponsor: National Development and Research Institutes, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Beth Israel Medical Center
First posted: 2011-12-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pain severity, as measured by the Multidimensional Pain Inventory (MPI)
timeFrame: 6 months
measure: pain interference, as measured by the Multidimensional Pain Inventory (MPI)
timeFrame: 6 months
measure: aberrant drug-related behavior, assessed via the Current Opioid Misuse Measure (COMM)
timeFrame: 6 months
Secondary outcomes:
measure: pain catastrophizing, measured by the Pain Catastrophizing Scale (PCS)
timeFrame: 6 months
measure: Emergency Department visits for pain
timeFrame: 6 months
Other outcomes:
measure: General Activities, Social Activities, Activities Away from Home, Household Chores
timeFrame: 6 months
measure: psychiatric distress, assessed via the SCL-10R
timeFrame: 6 months
measure: positive affect, assessed by the Positive Affect Negative Affect Scale (PANAS)
timeFrame: 6 months
measure: quality of life, as measured by the World Health Organization Quality of Life-BREF
timeFrame: 6 months
measure: social support, assessed by the MOS Social Support Scale
timeFrame: 6 months
measure: expectations about the future, assessed by the Future Scale
timeFrame: 6 months
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: National Development and Research Institutes, Inc.
name: Andrew Rosenblum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth College
name: Lisa A. Marsch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: