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A Telephone Feedback System for Prevention of Chronic Pain Relapse

Primary Purpose

Chronic Pain and Relapse Prevention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chronic pain therapeutic interactive voice response (TIVR) system
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain and Relapse Prevention focused on measuring Chronic Pain, Cognitive Therapy, Cognitive Behavioral Therapy, Recurrence, Relapse Prevention, Educational Technology, CBT, CST, IVR, TIVR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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 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

Sites / Locations

  • University of Vermont College of Medicine - MindBody Medicine Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Control - standard care only

Attention Control - standard care plus 6 months TIVR receiving minimal monthly feedback

Standard care plus 6 months TIVR receiving detailed monthly feedback

Outcomes

Primary Outcome Measures

Total pain experience and physical and social disability (as measured by the TOPS)
Pain level (as measured by the McGill Pain Questionnaire)
Catastrophizing and perceptions of control (as measured by the Coping Strategies Questionnaire)

Secondary Outcome Measures

Utilization of telephone system components during the study
Daily ratings of mood, pain, and coping use (measured by the TIVR Daily Questionnaire)
General measure of depressive symptoms (measured by the Beck Depression Inventory)

Full Information

First Posted
December 16, 2005
Last Updated
February 15, 2013
Sponsor
University of Vermont
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Vermont Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00266773
Brief Title
A Telephone Feedback System for Prevention of Chronic Pain Relapse
Official Title
Therapeutic Interactive Voice Response (IVR) for Relapse Prevention in Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Vermont Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain and Relapse Prevention
Keywords
Chronic Pain, Cognitive Therapy, Cognitive Behavioral Therapy, Recurrence, Relapse Prevention, Educational Technology, CBT, CST, IVR, TIVR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Control - standard care only
Arm Title
2
Arm Type
Experimental
Arm Description
Attention Control - standard care plus 6 months TIVR receiving minimal monthly feedback
Arm Title
3
Arm Type
Experimental
Arm Description
Standard care plus 6 months TIVR receiving detailed monthly feedback
Intervention Type
Behavioral
Intervention Name(s)
Chronic pain therapeutic interactive voice response (TIVR) system
Intervention Description
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
Primary Outcome Measure Information:
Title
Total pain experience and physical and social disability (as measured by the TOPS)
Time Frame
12 months
Title
Pain level (as measured by the McGill Pain Questionnaire)
Time Frame
12 months
Title
Catastrophizing and perceptions of control (as measured by the Coping Strategies Questionnaire)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Utilization of telephone system components during the study
Time Frame
daily for 6 months
Title
Daily ratings of mood, pain, and coping use (measured by the TIVR Daily Questionnaire)
Time Frame
daily for 6 months
Title
General measure of depressive symptoms (measured by the Beck Depression Inventory)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena R. Naylor, MD, PhD
Organizational Affiliation
University of Vermont College of Medicine - MindBody Medicine Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont College of Medicine - MindBody Medicine Clinic
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15162342
Citation
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.
Results Reference
background
PubMed Identifier
14622728
Citation
Naylor 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.
Results Reference
background
Links:
URL
http://www.med.uvm.edu/mbmc
Description
Click here for the University of Vermont College of Medicine - MindBody Medicine Clinic Web site

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A Telephone Feedback System for Prevention of Chronic Pain Relapse

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