A Telephone Feedback System for Prevention of Chronic Pain Relapse

February 15, 2013 updated by: Magdalena Naylor, MD, PhD, University of Vermont

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05403
        • University of Vermont College of Medicine - MindBody Medicine Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 1
Control - standard care only
EXPERIMENTAL: 2
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
EXPERIMENTAL: 3
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total pain experience and physical and social disability (as measured by the TOPS)
Time Frame: 12 months
12 months
Pain level (as measured by the McGill Pain Questionnaire)
Time Frame: 12 months
12 months
Catastrophizing and perceptions of control (as measured by the Coping Strategies Questionnaire)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Utilization of telephone system components during the study
Time Frame: daily for 6 months
daily for 6 months
Daily ratings of mood, pain, and coping use (measured by the TIVR Daily Questionnaire)
Time Frame: daily for 6 months
daily for 6 months
General measure of depressive symptoms (measured by the Beck Depression Inventory)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Vermont Medical Center

Investigators

  • Principal Investigator: Magdalena R. Naylor, MD, PhD, University of Vermont College of Medicine - MindBody Medicine Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

December 16, 2005

First Submitted That Met QC Criteria

December 16, 2005

First Posted (ESTIMATE)

December 19, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 15, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AR052131 (NIH)
  • 5R01AR052131 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe