Interactive Voice Response (IVR)-Based Treatment for Chronic Low Back Pain

• Numeric Rating Scale of Pain Intensity [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  

• Multidimensional Pain Inventory Interference subscale [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  
• Roland Morris Disability Questionnaire [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  
• SF36V [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  
• Profile of Mood States [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  
• Beck Depression Inventory [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  
• Pittsburgh Sleep Quality Index [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  
• Pain Stages of Change Questionnaire [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  
• Pain Catastrophizing Scale [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  
• Survey of Pain Attitudes [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  

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 pretreatment/baseline and at 3 and 6 months following baseline.

METHODOLOGY: Subjects will be 230 patients receiving care at the VACHS 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 (i.e., 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.