A Telephone Feedback System for Prevention of Chronic Pain Relapse

This study has been completed.
Sponsor:
Collaborators:
Fletcher Allen Health Care
Information provided by (Responsible Party):
Magdalena Naylor, MD, PhD, University of Vermont
ClinicalTrials.gov Identifier:
NCT00266773
First received: December 16, 2005
Last updated: February 15, 2013
Last verified: February 2013
  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
Chronic Pain and Relapse Prevention
Behavioral: Chronic pain therapeutic interactive voice response (TIVR) system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Interactive Voice Response (IVR) for Relapse Prevention in Chronic Pain

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Total pain experience and physical and social disability (as measured by the TOPS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pain level (as measured by the McGill Pain Questionnaire) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Catastrophizing and perceptions of control (as measured by the Coping Strategies Questionnaire) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Utilization of telephone system components during the study [ Time Frame: daily for 6 months ] [ Designated as safety issue: No ]
  • Daily ratings of mood, pain, and coping use (measured by the TIVR Daily Questionnaire) [ Time Frame: daily for 6 months ] [ Designated as safety issue: No ]
  • General measure of depressive symptoms (measured by the Beck Depression Inventory) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 158
Study Start Date: November 2005
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266773

Locations
United States, Vermont
University of Vermont College of Medicine - MindBody Medicine Clinic
Burlington, Vermont, United States, 05403
Sponsors and Collaborators
University of Vermont
Fletcher Allen Health Care
Investigators
Principal Investigator: Magdalena R. Naylor, MD, PhD University of Vermont College of Medicine - MindBody Medicine Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Magdalena Naylor, MD, PhD, Magdalena R. Naylor, MD, PhD, University of Vermont
ClinicalTrials.gov Identifier: NCT00266773     History of Changes
Other Study ID Numbers: R01 AR052131, R01AR052131, 5-R01-AR052131
Study First Received: December 16, 2005
Last Updated: February 15, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Vermont:
Chronic Pain
Cognitive Therapy
Cognitive Behavioral Therapy
Recurrence
Relapse Prevention
Educational Technology
CBT
CST
IVR
TIVR

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014