Chronic PainWebCBTPainNCT01498510
Web-based Cognitive-behavior Therapy (CBT) for Opioid-treated, Chronic Pain Patients With Aberrant Behavior
A study testing Web-based CBT for chronic pain in people with Chronic Pain, run by National Development and Research Institutes, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Web-based CBT for chronic pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, 10003
About this study
Official title: Web-based 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Web-based CBT for chronic pain
- Keywords
- chronic pain, cognitive behavior therapy, web-based intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based CBT for chronic painBehavioural
Also called cognitive behavior therapy (CBT), web-based intervention
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
| Study group | Role | What they receive |
|---|---|---|
| treatment-as-usual (TAU) | No intervention | The standard medical treatment provided to chronic pain patients at the study site pain specialty practice |
| TAU plus web-based intervention | Experimental | An interactive, web-based intervention, based on principles of cognitive behavior therapy (CBT), that teaches chronic pain patients with aberrant behavior self-management skills to reduce pain severity and medication misuse and improve functioning Receives: Behavioral: Web-based CBT for chronic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain severity, as measured by the Multidimensional Pain Inventory (MPI)
Measured: 6 months
pain interference, as measured by the Multidimensional Pain Inventory (MPI)
Measured: 6 months
aberrant drug-related behavior, assessed via the Current Opioid Misuse Measure (COMM)
Measured: 6 months
Secondary outcomes (2)
pain catastrophizing, measured by the Pain Catastrophizing Scale (PCS)
Measured: 6 months
Emergency Department visits for pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Beth Israel Medical Center
- Responsible party
- Sponsor
- Investigators
- Andrew Rosenblum, Ph.D., Principal investigator, National Development and Research Institutes, Inc.Lisa A. Marsch, Ph.D., Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498510
- Sponsor's protocol ID
- WebCBTPain618
- Other IDs
- R01DA026887
- Acronym
- WebCBTPain
- Status last verified
- May 2017
- First submitted
- 21 Dec 2011
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based CBT for Opioid-treated, Chronic Pain Patients With Aberrant Behavior
- ClinicalTrials.gov ID
- NCT01498510
- Acronym / sponsor ID
- WebCBTPain / WebCBTPain618
- Conditions
- Chronic Pain
- Keywords
- chronic pain, cognitive behavior therapy, web-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Beth Israel Medical Center
- Study start
- Feb 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment-as-usual (TAU) | No intervention | –The standard medical treatment provided to chronic pain patients at the study site pain specialty practice |
| TAU plus web-based intervention | Experimental | Behavioral: Web-based CBT for chronic painAn interactive, web-based intervention, based on principles of cognitive behavior therapy (CBT), that teaches chronic pain patients with aberrant behavior self-management skills to reduce pain severity and medication misuse and improve functioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based CBT for chronic painAlso: cognitive behavior therapy (CBT), web-based interventionAn 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 | Behavioural | TAU plus web-based intervention |
Primary outcome
pain severity, as measured by the Multidimensional Pain Inventory (MPI)
Time frame: 6 months
pain interference, as measured by the Multidimensional Pain Inventory (MPI)
Time frame: 6 months
aberrant drug-related behavior, assessed via the Current Opioid Misuse Measure (COMM)
Time frame: 6 months
2 secondary outcomes
pain catastrophizing, measured by the Pain Catastrophizing Scale (PCS)
Time frame: 6 months
Emergency Department visits for pain
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pain
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
Rewiring the Chronic Pain Experience: Single-Session Model of Pain Reprocessing Therapy (PRT) at The Ottawa Hospital
Chronic Pain
Active, not recruiting
Effects of Subtalar Mobilization With and Without Foot Core Strengthening in Chronic Plantar Heel Pain
Chronic Plantar Heel Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Rosenblum, Ph.D. principal investigator
National Development and Research Institutes, Inc.
Lisa A. Marsch, Ph.D. principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based CBT for chronic pain in people with Chronic Pain, run by National Development and Research Institutes, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain severity, as measured by the Multidimensional Pain Inventory (MPI) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.