Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266773
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2005-12-16
Brief Title:
A Telephone Feedback System for Prevention of Chronic Pain Relapse
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
Therapeutic Interactive Voice Response IVR for Relapse Prevention in Chronic Pain
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Medicines 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 participants daily questionnaire data Group 3 participants will receive full access to TIVR and will get personalized monthly messages from their therapist based on the participants daily questionnaire data Messages for participants will include any trends the therapist has noted in a participants 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
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 Medicines 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 participants daily questionnaire data Group 3 participants will receive full access to TIVR and will get personalized monthly messages from their therapist based on the participants daily questionnaire data Messages for participants will include any trends the therapist has noted in a participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AR052131 | NIH | None | httpsreporternihgovquickSearch5R01AR052131 |
| R01AR052131 | NIH | None | None |