Abstract
BackgroundChronic pain is a major health problem, and cognitive behavioral therapy (CBT) is its recommended treatment; however, efforts to develop CBT programs for chronic pain and assess their feasibility are remarkably delayed in Asia. Therefore, we conducted this pilot study to develop a basic individualized CBT for chronic pain (CBT-CP) and assessed its feasibility for use in Japan.MethodsOur study was an open-labeled before–after trial without a control group conducted cooperatively in five Japanese tertiary care hospitals. Of 24 outpatients, 15, age 20–80, who experienced chronic pain for at least three months were eligible. They underwent an eight-session CBT-CP consisting of relaxation via a breathing method and progressive muscle relaxation, behavioral modification via activity pacing, and cognitive modification via cognitive reconstruction. The EuroQol five-dimensional questionnaire five level (EQ5D-5 L) assessment as the primary outcome and quality of life (QOL), pain severity, disability, catastrophizing, self-efficacy, and depressive symptoms as secondary outcomes were measured using self-administered questionnaires at baseline, post-treatment, and 3-month follow-up. Intention-to-treat analyses were conducted.ResultsEffect size for EQ5D-5 L score was medium from baseline to post-treatment (Hedge’s g = − 0.72, 90% confidence interval = − 1.38 to − 0.05) and up to the 3-month follow-up (g = − 0.60, CI = − 1.22 to 0.02). Effect sizes for mental and role/social QOL, disability, catastrophizing, self-efficacy, and depressive symptoms were medium to large, although those for pain severity and physical QOL were small. The dropout rate was acceptably low at 14%. No severe adverse events occurred.ConclusionThe findings suggest that CBT-CP warrants a randomized controlled trial in Japan.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), UMIN000020880. Registered on 04 February 2016.
Highlights
Chronic pain is a major health problem, and cognitive behavioral therapy (CBT) is its recommended treatment; efforts to develop CBT programs for chronic pain and assess their feasibility are remarkably delayed in Asia
We did not use the third-generation CBT program, because the effect sizes in the second- and third-generation CBT programs were almost equivalent at the time we developed our CBT for chronic pain (CBT-CP) program
Participant flow, recruitment rate, and dropout rate Participants were recruited from 01 November 2016 and the last follow-up assessment was conducted on 23 January 2018
Summary
Our study was an open-labeled before–after trial without a control group conducted cooperatively in five Japanese tertiary care hospitals. Of 24 outpatients, 15, age 20–80, who experienced chronic pain for at least three months were eligible. They underwent an eight-session CBT-CP consisting of relaxation via a breathing method and progressive muscle relaxation, behavioral modification via activity pacing, and cognitive modification via cognitive reconstruction. Trial design and ethics The study was a pilot, open-labeled, before–after trial without a control group. We conducted the CBT-CP program among Japanese chronic pain patients and evaluated health-. The study was conducted cooperatively in five tertiary care hospitals in Japan, and the participants were recruited from each hospital. The study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR: UMIN000020880)
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