Web-based Cognitive-behavior Therapy (CBT) for Opioid-treated, Chronic Pain Patients With Aberrant Behavior (WebCBTPain)
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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 |
- 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 ]
- 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:
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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 |
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| Contact: Honoria Guarino, Ph.D. | 212-845-4540 | guarino@ndri.org |
| Contact: Andrew Rosenblum, Ph.D. | 212-845-4528 | rosenblum@ndri.org |
| 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. | |
| 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:
|
Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 18, 2013