IVR-based Cognitive Behavior Therapy for Chronic Low Back
Alicia Ann Heapy PhD
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, CT
Funding Period: July 2010 - June 2014
CBT is the most commonly cited psychological alternative to more traditional medical and rehabilitation approaches to chronic pain management and has demonstrated efficacy for reducing pain and improving function in persons with a broad spectrum of pain-related conditions. However, patient access to CBT is restricted by lack of transportation, funds for travel, mobility, and trained therapists in certain geographic areas. One mechanism for potentially expanding access to CBT is the use of technology such as interactive voice response (IVR). IVR is a computerized interface that allows patients to report and receive information via their telephone using a toll free telephone number. There is emerging evidence that IVR-based interventions are effective for providing education, peer support, providing tailored messages to enhance adherence, and maintaining and enhancing treatment gains for patients with a range of chronic conditions.
The primary purpose of this study is to test the hypothesis that Veterans with CLBP receiving IVR-based CBT (ICBT) will demonstrate, relative to standard face-to-face CBT (CBT), non-inferior declines in reports of pain intensity as measured by the numeric rating scale at post-treatment and follow-up.
Subjects will be 230 Veterans receiving care at VA Connecticut Healthcare System who report chronic low back pain of at least three months duration and at least a moderate level of average pain on a numerical rating scale of average pain. Following consent, participants will be randomized using a stratified block design to ICBT or CBT for 10 weeks of treatment. Distance to the VA will be the stratifying factor. Comprehensive evaluations will be conducted at baseline, post-treatment and two follow-up points. Daily reports of pain and adherence to coping skill practice will be collected using IVR for both treatment groups. The primary outcome will be patient reported pain intensity using the 11 point Numeric Rating Scale. For all analyses, an intent-to-treat approach will be employed, and clinical significance, in addition to statistical significance, will be assessed. Analysis of primary and secondary outcome measures will employ linear mixed-effects models for longitudinal data, which will account for the clustering induced by repeated measures on individual patients.
Data collection has recently begun, there are no findings.
We anticipate that if IVR-based CBT is found to have clinically non-inferior outcomes relative to in person CBT, IVR-based CBT will be an additional treatment option for Veterans with CLBP, especially rural Veterans and others with limited access to treatment.
DRA: Acute and Combat-Related Injury, Mental, Cognitive and Behavioral Disorders
DRE: Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Cognitive Therapy, Telemedicine/Telehealth
MeSH Terms: none