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| Sponsors and Collaborators: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) University of Vermont Fletcher Allen Health Care |
|---|---|
| Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT00266773 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pain and Relapse Prevention |
Behavioral: Chronic pain therapeutic interactive voice response (TIVR) system |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Therapeutic Interactive Voice Response (IVR) for Relapse Prevention in Chronic Pain |
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: No Intervention
Control - standard care only
|
Behavioral: Chronic pain therapeutic interactive voice response (TIVR) system
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
|
|
2: Experimental
Attention Control - standard care plus 6 months TIVR receiving minimal monthly feedback
|
Behavioral: Chronic pain therapeutic interactive voice response (TIVR) system
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
|
|
3: Experimental
Standard care plus 6 months TIVR receiving detailed monthly feedback
|
Behavioral: Chronic pain therapeutic interactive voice response (TIVR) system
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
|
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:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michele L. Comette, BA, Project Director | 802-847-8241 | mbmc@vtmednet.org |
| United States, Vermont | |
| University of Vermont College of Medicine - MindBody Medicine Clinic | Recruiting |
| Burlington, Vermont, United States, 05403 | |
| Contact: Magdalena R. Naylor, MD, PhD 802-847-2673 Magdalena.Naylor@vtmednet.org | |
| Principal Investigator: Magdalena R. Naylor, MD, PhD | |
| Principal Investigator: | Magdalena R. Naylor, MD, PhD | University of Vermont College of Medicine - MindBody Medicine Clinic |
More Information
| Responsible Party: | University of Vermont College of Medicine - MindBody Medicine Clinic ( Magdalena R. Naylor ) |
| Study ID Numbers: | R01 AR052131, 5-R01-AR052131 |
| Study First Received: | December 16, 2005 |
| Last Updated: | May 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00266773 History of Changes |
| Health Authority: | United States: Federal Government |
|
Chronic Pain Cognitive Therapy Cognitive Behavioral Therapy Recurrence Relapse Prevention |
Educational Technology CBT CST IVR TIVR |
|
Signs and Symptoms Neurologic Manifestations Pain Recurrence |
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Signs and Symptoms Disease Attributes Pathologic Processes Nervous System Diseases |
Neurologic Manifestations Pain Recurrence |