A Telephone Feedback System for Prevention of Chronic Pain Relapse

Sponsor

University of Vermont (Other)

Overall Status

Completed

CT.gov ID

NCT00266773

Collaborator

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

158

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain and Relapse Prevention	Behavioral: Chronic pain therapeutic interactive voice response (TIVR) system	N/A

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

Study Type:

Interventional

Actual Enrollment :

158 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Therapeutic Interactive Voice Response (IVR) for Relapse Prevention in Chronic Pain

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Total pain experience and physical and social disability (as measured by the TOPS) [12 months]
Pain level (as measured by the McGill Pain Questionnaire) [12 months]
Catastrophizing and perceptions of control (as measured by the Coping Strategies Questionnaire) [12 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)