Chronic PainNCT01794988
Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study
A study testing Group Cognitive Behavioral Therapy, Pain Education and Therapeutic Interactive Voice Response in people with Chronic Pain, run by University of Vermont at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether a psycho-therapeutic approach, group Cognitive Behavioral Therapy (CBT) plus a relapse prevention program, Therapeutic Interactive Voice Response (TIVR), modifies the dysfunctional sensory, emotional, and cognitive neural circuitry associated with chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Group Cognitive Behavioral Therapy, Pain Education and Therapeutic Interactive Voice Response
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 12 months of muscular-skeletal, non-neuropathic pain
Who cannot join
- Malignancy causing or influencing chronic pain
- Radiation or chemotherapy, or metastatic cancer of any type
- Reflex Sympathetic Dystrophy (RSD) and/or neuropathic pain
- Neurological disorders such as epilepsy or stroke, or other medical conditions
- Psychiatric disorders
- Opioid medication use for pain management
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- Past year history of illicit drug use that can result in altered cognition
- Pregnancy
- Exceeding weight limit of the MRI scanner
- Incompatible implants due to MRI safety
- Awaiting pain related surgical procedure
- Involved in pain-related litigation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Vermont College of Medicine, MindBody Medicine Clinic
Burlington, Vermont, 05401
Marcia A. Davis, CAGS, 802-847-8241, marcia.davis@vtmednet.org
About this study
The purpose of this study is to investigate whether a psycho-therapeutic approach, group Cognitive Behavioral Therapy (CBT) plus a relapse prevention program, Therapeutic Interactive Voice Response (TIVR), modifies the dysfunctional sensory, emotional, and cognitive neural circuitry associated with chronic pain.
- Conditions
- Chronic Pain
- Being tested
- Group Cognitive Behavioral Therapy, Pain Education, Therapeutic Interactive Voice Response, NO TIVR
- Keywords
- Acute Pain, Low Back Pain, Back Pain, Functional Magnetic Resonance Imaging (fMRI), Cognitive Behavioral Therapy, Pain Education
- Medical subject headings
- Chronic Pain, Acute Pain, Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Cognitive Behavioral TherapyBehavioural
Each CBT session will last 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques.
Pain EducationBehavioural
Subjects will receive mailed educational materials to their homes on a weekly basis. Weekly materials will contain information about the nature of chronic back pain, treatment options, exercises and stretching techniques for maintaining strength and flexibility, and proper protection for a healthy back. Pain education is the standard of care for most outpatient clinics.
Therapeutic Interactive Voice ResponseBehavioural
Therapeutic Interactive Voice Response as a daily self monitoring and relapse prevention tool with didactic reviews and practices of recorded skills and monthly feedback based on daily calls.
NO TIVRBehavioural
Control - no intervention
| Study group | Role | What they receive |
|---|---|---|
| Group Cognitive Behavioral Therapy | Experimental | Participants will undergo 11 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan. Receives: Behavioral: Group Cognitive Behavioral Therapy |
| Pain Education | Active comparator | Participants will receive 11 weeks of pain education and a pre- and post-intervention MRI brain scan. Receives: Behavioral: Pain Education |
| Therapeutic Interactive Voice Response | Experimental | Four months of therapeutic interactive voice response (TIVR). Receives: Behavioral: Therapeutic Interactive Voice Response |
| No TIVR | Active comparator | Control - no intervention Receives: Behavioral: NO TIVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: Seven Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startJul 2010
- Primary completionJun 2015 (estimated)
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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Magdalena Naylor, MD, PhD, University of Vermont
- Investigators
- Magdalena Naylor, MD, PhD, Principal investigator, Faculty, University of Vermont College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794988
- Sponsor's protocol ID
- R01AR059674-03
- Other IDs
- R01AR059674-03
- Status last verified
- Feb 2013
- First submitted
- 15 Feb 2013
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT01794988
- Acronym / sponsor ID
- R01AR059674-03
- Conditions
- Chronic Pain
- Keywords
- Acute Pain, Low Back Pain, Back Pain, Functional Magnetic Resonance Imaging (fMRI), Cognitive Behavioral Therapy, Pain Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jul 2010
- Primary completion
- Jun 2015 (estimated)
- First posted
- 20 Feb 2013 (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 investigate whether a psycho-therapeutic approach, group Cognitive Behavioral Therapy (CBT) plus a relapse prevention program, Therapeutic Interactive Voice Response (TIVR), modifies the dysfunctional sensory, emotional, and cognitive neural circuitry associated with chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group Cognitive Behavioral Therapy | Experimental | Behavioral: Group Cognitive Behavioral TherapyParticipants will undergo 11 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan. |
| Pain Education | Active comparator | Behavioral: Pain EducationParticipants will receive 11 weeks of pain education and a pre- and post-intervention MRI brain scan. |
| Therapeutic Interactive Voice Response | Experimental | Behavioral: Therapeutic Interactive Voice ResponseFour months of therapeutic interactive voice response (TIVR). |
| No TIVR | Active comparator | Behavioral: NO TIVRControl - no intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 12 months of muscular-skeletal, non-neuropathic pain
Key exclusion criteria (12 listed)
- Malignancy causing or influencing chronic pain
- Radiation or chemotherapy, or metastatic cancer of any type
- Reflex Sympathetic Dystrophy (RSD) and/or neuropathic pain
- Neurological disorders such as epilepsy or stroke, or other medical conditions
- Psychiatric disorders
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 |
|---|---|---|
| Group Cognitive Behavioral TherapyEach CBT session will last 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques. | Behavioural | Group Cognitive Behavioral Therapy |
| Pain EducationSubjects will receive mailed educational materials to their homes on a weekly basis. Weekly materials will contain information about the nature of chronic back pain, treatment options, exercises and stretching techniques for maintaining strength and flexibility, and proper protection for a healthy back. Pain education is the standard of care for most outpatient clinics. | Behavioural | Pain Education |
| Therapeutic Interactive Voice ResponseTherapeutic Interactive Voice Response as a daily self monitoring and relapse prevention tool with didactic reviews and practices of recorded skills and monthly feedback based on daily calls. | Behavioural | Therapeutic Interactive Voice Response |
| NO TIVRControl - no intervention | Behavioural | No TIVR |
Primary outcome
Pain
Time frame: Seven Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- MindBody Medicine Clinic Chronic Pain ResearchLink provided by the sponsor.
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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.
Magdalena Naylor, MD, PhD principal investigator
Faculty, University of Vermont College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Cognitive Behavioral Therapy, Pain Education and Therapeutic Interactive Voice Response in people with Chronic Pain, run by University of Vermont 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 1 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 20 Feb 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcia A. Davis, CAGS (802-847-8241, marcia.davis@vtmednet.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Seven Months). 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 20 Feb 2013.