Cognitive behavioral therapy for chronic pain (CBT-CP) is an evidence-based psychological intervention that is effective for reducing pain and improving function for patients with chronic pain. Numerous barriers exist to face-to-face delivery of this treatment, including patient travel limitations, the need for frequent in-person sessions, and the scarcity of trained therapists. Leveraging technology-based interventions, like interactive voice response (IVR), which allow patients to engage in treatment from their home, may improve access to CBT-CP. The overall goal of this project is to conduct a pragmatic trial to examine the real world effectiveness of an IVR-based form of CBT-CP called COoperative Pain Education and Self-management (COPES). In the spirit of pragmatic trials, our approach will minimize clinic disruption and avoid adding research staff in the field by using the VHA?s electronic health record (EHR) to facilitate recruitment and to collect data, all while delivering COPES from a centralized VA location. In preparation for the pragmatic trial, the initial study phase (UG3) will: a) identify facilities to participate in the trial from among the 60 Women?s Health Practice Based Network (WH-PBRN) sites, b) examine the adequacy of the EHR for providing outcome data, c) determine the feasibility of using EHR provider alerts to promote recruitment and d) secure all regulatory approvals along with support from leadership at selected sites. Phase two (UH3) will then compare outcomes among Veterans randomized to either: 1) COPES, a 10-week IVR-based CBT and walking program plus any provider prescribed pharmacological and non-pharmacological pain treatments (COPES+UC), or 2) in-person CBT-CP provided by clinicians, previously trained through VHA?s evidence based psychotherapy program plus any provider prescribed pharmacological and non-pharmacological treatments (VHA CBT-CP+UC). Patients will be compared on a composite measure of pain intensity and functioning, EHR pain intensity, and health care use including emergency department, urgent care, and specialty pain services along with pharmacological and non-pharmacological pain interventions. Uptake and variation in outcomes across groups will also be evaluated where treatment disparities are possible (e.g. by sex, race, mental health comorbidities). Additionally, the cost of the COPES intervention will be examined, including intervention delivery expenditures and budget impact analysis. Finally, evaluation of the intervention process will be informed by the Consolidated Framework for Implementation Research (CFIR). CFIR-guided interviews with study site clinicians and administrators will assess experiences with the COPES and CBT-CP interventions and implementation findings will be communicated with participating sites and stakeholders.

Public Health Relevance

Cognitive behavioral therapy for chronic pain (CBT-CP) is an evidence-based intervention that is effective in reducing pain and improving function for Veterans with chronic pain, yet numerous barriers exist to widespread implementation of traditional CBT-CP, including patient travel limitations, the need for frequent in-person sessions, and the scarcity of trained therapists. Because technology-based interventions, like interactive voice response (IVR), allow patients to engage in treatment from their home, they may improve access to CBT-CP. The aim of the current project is to compare the real-world effectiveness of IVR-delivered CBT-CP compared to in-person CBT-CP in VHA settings.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Project #
1UG3AT009767-01
Application #
9446487
Study Section
Special Emphasis Panel (ZAT1)
Program Officer
Clark, David
Project Start
2017-09-20
Project End
2019-08-31
Budget Start
2017-09-20
Budget End
2018-08-31
Support Year
1
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Yale University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520