Chronic Pain and Relapse Prevention Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment