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IIR 09-058 – HSR&D Study

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IIR 09-058
IVR-based Cognitive Behavior Therapy for Chronic Low Back
Alicia A. Heapy PhD
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, CT
Funding Period: July 2010 - June 2015

BACKGROUND/RATIONALE:
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. To our knowledge, this study represents the first trial of IVR-based CBT for chronic pain that uses IVR as the sole means to deliver CBT. It is one of the very few trials that compares a technology-assisted treatment to in-person treatment, the gold standard of care.

OBJECTIVE(S):
The primary purpose of this study is to test the hypothesis that Veterans with chronic low back pain receiving IVR-based CBT (ICBT) will demonstrate, relative to standard face-to-face CBT (CBT), non-inferior (not meaningfully worse) declines in reports of pain intensity as measured by the numeric rating scale at post-treatment and follow-up, within a margin of non-inferiority of 1. Secondarily, Veterans receiving ICBT, relative to CBT, will demonstrate non-inferior improvements in reports of physical and emotional functioning at post-treatment and follow-up.

METHODS:
Subjects were 125 Veterans receiving care at VA Connecticut Healthcare System who reported chronic low back pain of at least three months duration and at least a moderate level of average pain intensity on a numerical rating scale. Following consent, participants were randomized using a stratified block design to ICBT or CBT for 10 weeks of treatment. Distance to the VA and cause of back pain were the stratifying factors. Comprehensive evaluations were conducted at baseline, post-treatment (14 weeks) and two follow-up points (6 and 9 months). Participants in both treatment groups made daily reports of their pain intensity, pedometer-measured step counts, sleep, and adherence to pain coping skill practice via automated IVR calls. The primary outcome was patient reported pain intensity using the 11 point Numeric Rating Scale. We used mixed models for repeated measures to compare ICBT and CBT in terms of mean changes in outcomes from baseline to the 3 follow-up time points (post-treatment, 6 month, and 9 month). Only post-treatment data is presented here as not all participants have completed all assessment points. The models included treatment, time, the treatment-by-time interaction, the baseline value of the outcome, and the stratifying factors (distance from VA and cause of back pain). An unstructured variance-covariance matrix was used to model the error variance. The mixed model can accommodate missing outcome data and provides valid inferences in the presence of missing data provided that the data is missing at random (probability a variable is missing depends only on the observed data). Results are summarized as model adjusted means, that is, Least Square means (LS Means) and their 95% confidence intervals (CI). Non-inferiority of ICBT relative to CBT in terms of pain intensity was concluded if the upper limit of the CI for the difference between the two was lower than 1. All hypothesis tests were two-sided and conducted at a significance level of alpha=0.05. No corrections were made for multiple testing.

FINDINGS/RESULTS:
Of the 508 participants who were assessed for eligibility, 219 were not eligible and 155 declined participation, leaving 134 who consented to be in the trial. After consent, nine participants were screen failures at baseline leaving 125 participants who were randomized to treatment (I-CBT n=62 and CBT n=63). At baseline, the mean age of participants was 57.9 (SD=11.6, range 28-88) years, 78% were men and mean education was 13.9 years (SD=2.07). The majority of participants were white (65%), 26% were black, 7% were Hispanic, and 2% identified as "other". There were no significant differences on any demographic or clinical characteristics between the groups at baseline.
Ninety-three subjects had at least one of the post-baseline surveys available and were included in the mixed model analyses. For the primary outcome, average NRS pain intensity at post-treatment, the LS mean reduction from baseline was -.65 (95% CI -1.19 to -.11) for IVR and -.79 (95% CI -1.36 to -0.22) for CBT. The mean difference between ICBT and CBT (.14, 95% CI -.63 to .91, effect size .09 in favor of CBT) was not statistically significant and indicated non-inferiority of ICBT (upper limit of CI<1). For the secondary outcomes (see QUAD chart table), the mean difference between ICBT and CBT was not statistically significant for the West Haven-Yale Multidimensional Pain Inventory (WHYMPI) interference subscale, the Roland Morris Disability Questionnaire (RMDQ), the Pittsburgh Sleep Quality Index (PSQI), or the Beck Depression Inventory (BDI). Participants in both conditions generally demonstrated significant improvements in all the secondary outcomes from pre to post-treatment except for the BDI. Participants in the ICBT condition completed a mean of 8.8 sessions compared to 6.5 sessions in the CBT condition.

IMPACT:
We found that CBT delivered via an automated Interactive Voice Response (IVR) system leads to patient-centered outcomes that are no less effective than standard VA approaches in which CBT is delivered in-person by a therapist. Because ICBT uses scalable, automated messaging to deliver in-home self-management support, it has the potential to reach the large number of Veterans with chronic pain who have limited access to specialty pain management services. Successful implementation of this system could provide a foundation for future work on similar interventions to improve chronic illness care cost-effectively using mobile health models for Veterans with high priority chronic conditions such as depression, diabetes, and obesity.

PUBLICATIONS:

Journal Articles

  1. Higgins DM, LaChappelle KM, Serowik KL, Driscoll M, Lee A, Heapy AA. Predictors of Participation in a Nonpharmacological Intervention for Chronic Back Pain. Pain medicine (Malden, Mass.). 2018 Sep 1; 19(suppl_1):S76-S83.
  2. Heapy AA, Higgins DM, Goulet JL, LaChappelle KM, Driscoll MA, Czlapinski RA, Buta E, Piette JD, Krein SL, Kerns RD. Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial. JAMA internal medicine. 2017 Jun 1; 177(6):765-773.
  3. Heapy AA, Higgins DM, LaChappelle KM, Kirlin J, Goulet JL, Czlapinski RA, Buta E, Piette JD, Krein SL, Richardson CR, Kerns RD. Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain. BMC musculoskeletal disorders. 2016 Feb 16; 17:85.
Book Chapters

  1. Rosenberger PH, Heapy AA, Kerns RD. Pain Assessment. In: In Rehabilitation and health assessment: Applying the ICF guidelines. New York: Springer Publishing Company; 2010. Chapter 427. 453 p.
Conference Presentations

  1. Wandner L, LaChappelle K, Czlapinski R, Higgins D, Janevic M, Piette J, Kerns R, Heapy AA. Identifying and categorizing patient-generated pain treatment goals. Poster session presented at: American Pain Society Annual Meeting; 2015 May 13; Palm Springs, CA.
  2. Heapy AA, LaChappelle KM, Higgins DM, Kerns RD. Preliminary results of a technology-assisted intervention to promote walking among individuals with chronic pain. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2015 Apr 23; San Antonio, TX.
  3. Kerns RD, Heapy AA, Higgins DM, LaChappelle KM, Czlapinski RA, Kirlin JP. Initial feasibility reports of a novel Cognitive Behavioral Therapy (CBT) pain self-management treatment modality. Poster session presented at: American Pain Society Annual Meeting; 2014 May 1; Tampa, FL.


DRA: Mental, Cognitive and Behavioral Disorders, Acute and Combat-Related Injury
DRE: Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Cognitive Therapy, Telemedicine/Telehealth
MeSH Terms: none