Chronic Pain and Relapse PreventionNCT00266773
A Telephone Feedback System for Prevention of Chronic Pain Relapse
A study testing Chronic pain therapeutic interactive voice response (TIVR) system in people with Chronic Pain and Relapse Prevention, run by University of Vermont at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a telephone-based self-monitoring and skills review program with personalized therapist feedback following group CST for chronic pain can reduce and prevent relapse of the pain, physical disability, and psychological distress experienced by patients with chronic pain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain and Relapse Prevention
- What is being tested?
- Chronic pain therapeutic interactive voice response (TIVR) system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jan 2012
- 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
- Completed 11 weeks of CST through the University of Vermont College of Medicine - Health Behavior Research Center prior to study entry
- At least 6 months of musculoskeletal pain caused by back, neck, or shoulder pain; osteoarthritis; or fibromyalgia
- Meet study threshold for pain severity with a Typical Pain score of 4 or more on a 10-point scale adapted from the McGill Pain Questionnaire (80)
- Receiving ongoing standard pain management from a physician (typically involving oral analgesic medication and physical therapy, with or without anesthetic or steroid injections)
Who cannot join
- Unable to perform usual self care
- Cancer that causes or influences patient's chronic pain
- Cancer requiring radiation or chemotherapy or metastatic cancer of any type
- Reflex sympathetic dystrophy (RSD)
- Neuropathic pain
- Awaiting a pain-related surgical procedure
Show all 10Show fewer
- Involved in pain-related litigation or awaiting disability determination
- Behavioral problems or psychotic disorders that may interfere with the study
- Inability to use telephone-based TIVR due to cognitive or hearing impairment
- At risk for suicide
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont College of Medicine - MindBody Medicine Clinic
Burlington, Vermont, 05403
About this study
Official title: Therapeutic Interactive Voice Response (IVR) for Relapse Prevention in Chronic Pain
The purpose of this study is to determine whether a telephone-based self-monitoring and skills review program with personalized therapist feedback following group CST for chronic pain can reduce and prevent relapse of the pain, physical disability, and psychological distress experienced by patients with chronic pain of the muscles and bone.
Read the detailed description
IVR (Interactive Voice Response) is a computer-based, automated telephone system that enables callers to respond to a recorded voice via the telephone keypad. Using this technology, therapeutic IVR (TIVR) was developed as a tool for providing maintenance treatment following group cognitive-behavioral coping skills training (CST), a widely-used behavioral treatment for chronic pain. TIVR has four components:
- an automated daily questionnaire for self-monitoring
- a review of coping skills
- guided behavioral rehearsals of CST coping skills
- personalized monthly feedback messages recorded onto TIVR by the therapist
All four components can be accessed remotely by patients via any touch-tone phone. In a small pilot study, people with severe, chronic musculoskeletal pain received 11 weeks of either CST alone or CST with TIVR access and therapist feedback. Those who used TIVR had better pain outcomes than those who did not. This study will compare the effectiveness of TIVR with or without therapist feedback to a control group not using TIVR at all.
To be eligible for this study, participants must have just completed an 11-week course of CST through the University of Vermont College of Medicine's MindBody Medicine Clinic. At study entry, participants will be randomly assigned to one of three groups. Group 1 is a control group that will not receive any intervention through this study. Group 2 participants will receive full access to TIVR and will get a minimal monthly message from their therapist, who will not use the participant's daily questionnaire data. Group 3 participants will receive full access to TIVR and will get personalized monthly messages from their therapist based on the participant's daily questionnaire data. Messages for participants will include any trends the therapist has noted in a participant's stress, sleep, mood, pain levels, coping, and activity, as reported through TIVR. All study participants may continue to receive treatment from their regular physician or take part in other pain management techniques during this study, but such treatment will not be provided through this study.
Upon completing the 11 weeks of CST, all participants will be asked to complete a packet of questionnaires about their chronic pain. At the start of this study, participants in Groups 2 and 3 will have a 30-minute training session on how to use and access TIVR. At Months 4, 8, and 12, participants from all three groups will have follow-up interviews and will complete additional questionnaires.
- Conditions
- Chronic Pain and Relapse Prevention
- Being tested
- Chronic pain therapeutic interactive voice response (TIVR) system
- Keywords
- Chronic Pain, Cognitive Therapy, Cognitive Behavioral Therapy, Recurrence, Relapse Prevention, Educational Technology, CBT, CST, IVR, TIVR
- Medical subject headings
- Chronic Pain, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic pain therapeutic interactive voice response (TIVR) systemBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Control - standard care only |
| 2 | Experimental | Attention Control - standard care plus 6 months TIVR receiving minimal monthly feedback Receives: Behavioral: Chronic pain therapeutic interactive voice response (TIVR) system |
| 3 | Experimental | Standard care plus 6 months TIVR receiving detailed monthly feedback Receives: Behavioral: Chronic pain therapeutic interactive voice response (TIVR) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pain experience and physical and social disability (as measured by the TOPS)
Measured: 12 months
Pain level (as measured by the McGill Pain Questionnaire)
Measured: 12 months
Catastrophizing and perceptions of control (as measured by the Coping Strategies Questionnaire)
Measured: 12 months
Secondary outcomes (3)
Utilization of telephone system components during the study
Measured: daily for 6 months
Daily ratings of mood, pain, and coping use (measured by the TIVR Daily Questionnaire)
Measured: daily for 6 months
General measure of depressive symptoms (measured by the Beck Depression Inventory)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain and Relapse PreventionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
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), University of Vermont Medical Center
- Responsible party
- Principal investigator, Magdalena Naylor, MD, PhD, University of Vermont
- Investigators
- Magdalena R. Naylor, MD, PhD, Principal investigator, University of Vermont College of Medicine - MindBody Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266773
- Sponsor's protocol ID
- R01AR052131
- Other IDs
- R01AR052131, 5R01AR052131
- Status last verified
- Feb 2013
- First submitted
- 16 Dec 2005
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Keefe FJ, Rumble ME, Scipio CD, Giordano LA, Perri LM. Psychological aspects of persistent pain: current state of the science. J Pain. 2004 May;5(4):195-211. doi: 10.1016/j.jpain.2004.02.576.
PubMed 15162342Naylor MR, Helzer JE, Naud S, Keefe FJ. Automated telephone as an adjunct for the treatment of chronic pain: a pilot study. J Pain. 2002 Dec;3(6):429-38. doi: 10.1054/jpai.2002.129563.
PubMed 14622728
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Interactive Voice Response (IVR) for Relapse Prevention in Chronic Pain
- ClinicalTrials.gov ID
- NCT00266773
- Acronym / sponsor ID
- R01AR052131
- Conditions
- Chronic Pain and Relapse Prevention
- Keywords
- Chronic Pain, Cognitive Therapy, Cognitive Behavioral Therapy, Recurrence, Relapse Prevention, Educational Technology, CBT, CST
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Vermont Medical Center
- Study start
- Nov 2005
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 19 Dec 2005 (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 determine whether a telephone-based self-monitoring and skills review program with personalized therapist feedback following group CST for chronic pain can reduce and prevent relapse of the pain, physical disability, and psychological distress experienced by patients with chronic pain of the muscles and bone.
Detailed description
IVR (Interactive Voice Response) is a computer-based, automated telephone system that enables callers to respond to a recorded voice via the telephone keypad. Using this technology, therapeutic IVR (TIVR) was developed as a tool for providing maintenance treatment following group cognitive-behavioral coping skills training (CST), a widely-used behavioral treatment for chronic pain. TIVR has four components:
- an automated daily questionnaire for self-monitoring
- a review of coping skills
- guided behavioral rehearsals of CST coping skills
- personalized monthly feedback messages recorded onto TIVR by the therapist
All four components can be accessed remotely by patients via any touch-tone phone. In a small pilot study, people with severe, chronic musculoskeletal pain received 11 weeks of either CST alone or CST with TIVR access and therapist feedback. Those who used TIVR had better pain outcomes than those who did not. This study will compare the effectiveness of TIVR with or without therapist feedback to a control group not using TIVR at all.
To be eligible for this study, participants must have just completed an 11-week course of CST through the University of Vermont College of Medicine's MindBody Medicine Clinic. At study entry, participants will be randomly assigned to one of three groups. Group 1 is a control group that will not receive any intervention through this study. Group 2 participants will receive full access to TIVR and will get a minimal monthly message from their therapist, who will not use the participant's daily questionnaire data. Group 3 participants will receive full access to TIVR and will get personalized monthly messages from their therapist based on the participant's daily questionnaire data. Messages for participants will include any trends the therapist has noted in a participant's stress, sleep, mood, pain levels, coping, and activity, as reported through TIVR. All study participants may continue to receive treatment from their regular physician or take part in other pain management techniques during this study, but such treatment will not be provided through this study.
Upon completing the 11 weeks of CST, all participants will be asked to complete a packet of questionnaires about their chronic pain. At the start of this study, participants in Groups 2 and 3 will have a 30-minute training session on how to use and access TIVR. At Months 4, 8, and 12, participants from all three groups will have follow-up interviews and will complete additional questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Control - standard care only |
| 2 | Experimental | Behavioral: Chronic pain therapeutic interactive voice response (TIVR) systemAttention Control - standard care plus 6 months TIVR receiving minimal monthly feedback |
| 3 | Experimental | Behavioral: Chronic pain therapeutic interactive voice response (TIVR) systemStandard care plus 6 months TIVR receiving detailed monthly feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completed 11 weeks of CST through the University of Vermont College of Medicine - Health Behavior Research Center prior to study entry
- At least 6 months of musculoskeletal pain caused by back, neck, or shoulder pain; osteoarthritis; or fibromyalgia
- Meet study threshold for pain severity with a Typical Pain score of 4 or more on a 10-point scale adapted from the McGill Pain Questionnaire (80)
- Receiving ongoing standard pain management from a physician (typically involving oral analgesic medication and physical therapy, with or without anesthetic or steroid injections)
Key exclusion criteria (10 listed)
- Unable to perform usual self care
- Cancer that causes or influences patient's chronic pain
- Cancer requiring radiation or chemotherapy or metastatic cancer of any type
- Reflex sympathetic dystrophy (RSD)
- Neuropathic pain
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 |
|---|---|---|
| Chronic pain therapeutic interactive voice response (TIVR) systemTherapeutic 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 | 2, 3 |
Primary outcome
Total pain experience and physical and social disability (as measured by the TOPS)
Time frame: 12 months
Pain level (as measured by the McGill Pain Questionnaire)
Time frame: 12 months
Catastrophizing and perceptions of control (as measured by the Coping Strategies Questionnaire)
Time frame: 12 months
3 secondary outcomes
Utilization of telephone system components during the study
Time frame: daily for 6 months
Daily ratings of mood, pain, and coping use (measured by the TIVR Daily Questionnaire)
Time frame: daily for 6 months
General measure of depressive symptoms (measured by the Beck Depression Inventory)
Time frame: 12 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 18 Feb 2013.
- Background: PubMed 15162342Keefe FJ, Rumble ME, Scipio CD, Giordano LA, Perri LM. Psychological aspects of persistent pain: current state of the science. J Pain. 2004 May;5(4):195-211. doi: 10.1016/j.jpain.2004.02.576.
- Background: PubMed 14622728Naylor MR, Helzer JE, Naud S, Keefe FJ. Automated telephone as an adjunct for the treatment of chronic pain: a pilot study. J Pain. 2002 Dec;3(6):429-38. doi: 10.1054/jpai.2002.129563.
- Click here for the University of Vermont College of Medicine - MindBody Medicine Clinic Web siteLink provided by the sponsor.
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 R. Naylor, MD, PhD principal investigator
University of Vermont College of Medicine - MindBody Medicine Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic pain therapeutic interactive voice response (TIVR) system in people with Chronic Pain and Relapse Prevention, 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 4 inclusion and 10 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 18 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?
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?
Total pain experience and physical and social disability (as measured by the TOPS) (time frame: 12 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?
On the ClinicalTrials.gov record for NCT00266773, which also lists 2 linked publications.
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 18 Feb 2013; AzTrials last refreshed its copy on 7 Nov 2026.