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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by National Development and Research Institutes, Inc.
Sponsor:
Collaborators:
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 2, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to develop and evaluate an innovative, web-based psychosocial intervention for opioid-treated chronic pain patients who display aberrant drug-related behavior.


Condition Intervention
Chronic Pain
Behavioral: Therapeutic Education System (TES) for chronic pain

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 West-Haven-Yale Multidimensional Pain Inventory (WHYMPI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • pain interference behaviors, as measured by the West-Haven-Yale Multidimensional Pain Inventory (WHYMPI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • aberrant drug-related behaviors, assessed via the Current Opioid Misuse Measure (COMM) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • aberrant drug-related behaviors, as assessed by physicians via the Addiction Behavior Checklist (ABC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • substance misuse, as measured by the Individual Assessment Profile (IAP) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • psychiatric distress, assessed via the SCL-10R [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • HIV risk behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • quality of life, as measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • positive affect, assessed via the positive affect subscale of the Positive Affect Negative Affect Scale (PANAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • satisfaction with pain treatment, measured via the Pain Service Satisfaction Test (PSST) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: treatment-as-usual (TAU)
the standard treatment provided to patients with chronic pain at our study site
Experimental: TAU plus web-based intervention
The Therapeutic Education System (TES) for chronic pain is an interactive, web-based intervention, based on principles of cognitive behavior therapy (CBT), designed to train chronic pain patients in self-management skills to reduce pain severity and improve functioning
Behavioral: Therapeutic Education System (TES) for chronic pain
an interactive, web-delivered intervention based on principles of cognitive behavior therapy (CBT) designed to train chronic pain patients in self-management skills to reduce pain severity and improve functioning
Other Names:
  • cognitive behavior therapy (CBT)
  • web-based intervention

Detailed Description:

Although opioid therapy has gained increasing acceptance as a treatment for patients with chronic, non-malignant pain, concerns persist related to achievement of treatment goals and medication misuse/abuse within the clinical context(often described as aberrant drug-related behavior). Psychosocial approaches, particularly self-manangement 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, largely due to the lack of expertise and time among physicians who prescribe opioids. To address this public health concern, this study will develop, implement and evaluate an innovative CBT intervention for the treatment of chronic pain tailored to the specific needs of patients who are prescribed opioids and present with aberrant behaviors. The development of this interactive, web-based intervention will include input as well as feedback on a beta version from pain experts and chronic pain patients. Once the intervention has been developed, we will conduct a controlled efficacy trial in which chronic pain patients maintained on opioids will be randomized to receive either treatment-as-usual (n=55) or treatment-as-usual plus the computer-delivered intervention (n=55). In addition to conducting statistical analyses to evaluate the relative efficacy of these two interventions, we will examine two hypothesized mediators of treatment outcome - i.e., cognitive distortions relative to pain management and coping, and expectations about the future.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  • new patients at pain treatment program study site (within 60 days of treatment entry) prescribed opioid analgesics
  • aberrant drug-related behavior within the past 6 months (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

Contacts
Contact: Honoria Guarino, Ph.D. 212-845-4540 guarino@ndri.org
Contact: Andrew Rosenblum, Ph.D. 212-845-4528 rosenblum@ndri.org

Locations
United States, New York
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Russell Portenoy, M.D.    212-844-1505    rportenoy@chpnet.org   
Contact: Arun Sundaram, B.A.    212-844-8533    asundaram@chpnet.org   
Principal Investigator: Russell Portenoy, M.D.         
Sponsors and Collaborators
National Development and Research Institutes, Inc.
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-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier: NCT01498510     History of Changes
Other Study ID Numbers: WebCBTPain618, R01DA026887
Study First Received: December 21, 2011
Last Updated: May 2, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

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
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014