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Completed

NCT Number: NCT01498510

Web-based Cognitive-behavior Therapy (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Medical Center

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based CBT for chronic pain

Behavioral

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

Primary outcomes

  1. pain severity, as measured by the Multidimensional Pain Inventory (MPI)

    Time frame: 6 months

  2. pain interference, as measured by the Multidimensional Pain Inventory (MPI)

    Time frame: 6 months

  3. aberrant drug-related behavior, assessed via the Current Opioid Misuse Measure (COMM)

    Time frame: 6 months

Secondary outcomes

  1. pain catastrophizing, measured by the Pain Catastrophizing Scale (PCS)

    Time frame: 6 months

  2. Emergency Department visits for pain

    Time frame: 6 months

Other outcomes

  1. General Activities, Social Activities, Activities Away from Home, Household Chores

    Time frame: 6 months

    activity sub-scales of the Multidimensional Pain Inventory (MPI)

  2. psychiatric distress, assessed via the SCL-10R

    Time frame: 6 months

  3. positive affect, assessed by the Positive Affect Negative Affect Scale (PANAS)

    Time frame: 6 months

  4. quality of life, as measured by the World Health Organization Quality of Life-BREF

    Time frame: 6 months

  5. social support, assessed by the MOS Social Support Scale

    Time frame: 6 months

  6. expectations about the future, assessed by the Future Scale

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

National Development and Research Institutes, Inc.

Other

Collaborators

  • Beth Israel Medical Center
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Web-based CBT for Opioid-treated, Chronic Pain Patients With Aberrant Behavior

Acronym: WebCBTPain

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Dec 23, 2011
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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