Ignite Creation Date:
2024-05-05 @ 10:05 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01025752
Status:
COMPLETED
Last Update Posted:
2018-08-03
First Post:
2009-12-03
Brief Title:
Interactive Voice Response IVR-Based Treatment for Chronic Low Back Pain
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
IVR-based Cognitive Behavior Therapy for Chronic Low Back
Status:
COMPLETED
Status Verified Date:
2017-10
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 proposed study will test how well an innovative method interactive voice response IVR can be used for delivering an treatment for chronic low back pain The use of IVR will improve the accessibility of treatment to Veterans IVR is a computerized interface that allows patients to use their telephone to 1 obtain pre-recorded didactic information 2 report data regarding pain-related symptoms and adherence to pain coping skill practice and 3 receive personalized therapist feedback Although CBT has been shown to be effective in reducing pain intensity traditional CBT requires patients to make frequent office visits The use of IVR will allow Veterans to access CBT from their home via a touch-tone telephone thereby allowing them to access treatment at their convenience without travel to the VA for an outpatient appointment Veterans with chronic low back pain will be randomized in equal numbers to receive either standard CBT or IVR-based CBT Veterans in both conditions will receive 10 session of treatment designed to help them manage their chronic pain using pain coping skills The primary outcome measure will be pain intensity
Detailed Description:
OBJECTIVES The primary purpose of this study is to test the efficacy of an innovative method interactive voice response IVR for delivering an empirically validated psychological cognitive behavior therapy CBT treatment for chronic pain in order to improve access and sustainability of this intervention The primary clinical equivalence hypothesis states that Veterans with chronic low back pain CLBP receiving IVR-based CBT ICBT will demonstrate relative to standard face-to-face CBT CBT equivalent declines in reports of pain intensity as measured by the numeric rating scale at post-treatment and follow-up The secondary hypothesis states that Veterans with CLBP receiving ICBT relative to CBT will demonstrate equivalent declines in reports of pain-related interference and emotional distress at post-treatment and follow-up
RESEARCH DESIGN A randomized design will be employed in which standard CBT CBT is compared to an Interactive CBT ICBT treatment condition Participants will be randomized in equal numbers to both conditions Repeated assessments of key outcome domains will occur at pretreatmentbaseline and at 3 and 6 months following baseline
METHODOLOGY Subjects will be 230 patients receiving care at the VA Connecticut Healthcare System who report chronic low back pain The primary criteria for inclusion are constant pain of at least three months duration with at least a moderate level of average pain ie scores of 4 or greater on a 0 no pain to 10 worst pain imaginable on a numerical rating scale of average pain All patients must have access to a touch-tone telephone Excluded will be patients with life threatening or acute physical illness current alcohol or substance abuse or dependence current psychosis suicidal ideation dementia and individuals seeking surgical pain treatment Comprehensive evaluations will be conducted at each assessment interval Following completion of written consent and an initial baseline evaluation participants will be randomized to one of the two treatments Sessions will be audiotaped to ensure the fidelity of the face-to-face CBT sessions and the personalized therapist feedback in the IVR-based CBT condition Both conditions will involve 10 outpatient therapy sessions with a psychologist trained experienced in the delivery of these treatments Adherence to coping skill practice will be assessed using IVR for both treatment groups Analysis of primary and secondary outcome measures will employ mixed-effects models which will account for the clustering induced by repeated measures on individual patients
RESEARCH DESIGN A randomized design will be employed in which standard CBT CBT is compared to an Interactive CBT ICBT treatment condition Participants will be randomized in equal numbers to both conditions Repeated assessments of key outcome domains will occur at pretreatmentbaseline and at 3 and 6 months following baseline
METHODOLOGY Subjects will be 230 patients receiving care at the VA Connecticut Healthcare System who report chronic low back pain The primary criteria for inclusion are constant pain of at least three months duration with at least a moderate level of average pain ie scores of 4 or greater on a 0 no pain to 10 worst pain imaginable on a numerical rating scale of average pain All patients must have access to a touch-tone telephone Excluded will be patients with life threatening or acute physical illness current alcohol or substance abuse or dependence current psychosis suicidal ideation dementia and individuals seeking surgical pain treatment Comprehensive evaluations will be conducted at each assessment interval Following completion of written consent and an initial baseline evaluation participants will be randomized to one of the two treatments Sessions will be audiotaped to ensure the fidelity of the face-to-face CBT sessions and the personalized therapist feedback in the IVR-based CBT condition Both conditions will involve 10 outpatient therapy sessions with a psychologist trained experienced in the delivery of these treatments Adherence to coping skill practice will be assessed using IVR for both treatment groups Analysis of primary and secondary outcome measures will employ mixed-effects models which will account for the clustering induced by repeated measures on individual patients
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