Trials · 2025
Individualized cognitive behavioral therapy for chronic pain in Japan: study protocol for a multicenter randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Hosogoshi Hiroki, Iwasa Kazunori, Fukumori Takaki, Takagishi Yuriko, Takebayashi Yoshitake, Tairako Yukino, Oe Yuki, Adachi Tomonori, Enomoto Kiyoka, Yokoyama Satoshi, Kurata Jiro, Matsui Ayano, Nishie Hiroyuki, Sato Hitoaki, Takahashi Noriyo, Watanabe Keisuke, Fujiwara Aki, Yoshino Atsuo, Toyota Ayaka, Horikoshi Masaru, Shibata Masahiko
Аннотация
BACKGROUND: Chronic pain imposes a substantial burden on individuals and society. Cognitive behavioral therapy for chronic pain (CBT-CP) has proven effective internationally, but randomized evidence in Japan is scarce. The first Japanese trial was a single-center, 16-session videoconference program that prioritized pain intensity. In contrast, this multicenter trial tests a brief, face-to-face, individualized CBT-CP program with quality of life (QoL) as the primary outcome.
METHODS: This open-label, randomized, parallel-group superiority trial enrolls 60 adults aged 20-80 years with chronic pain persisting ≥ 3 months and EQ-5D-5L scores ≤ 0.80, indicating reduced QoL. Participants are randomized 1:1 to treatment as usual (TAU) plus an eight-session CBT-CP program or to a waitlist control receiving TAU only. The manualized intervention includes psycho-education, relaxation, activity pacing, and cognitive restructuring, delivered weekly face-to-face, with the goal of completing eight sessions within 14 weeks. If necessary, sessions may extend beyond the 15th week; however, the post-assessment is always conducted at 15 ± 2 weeks irrespective of intervention timing. Therapists meet prespecified eligibility criteria and receive structured training, supervision, and fidelity monitoring. The primary outcome is QoL (EQ-5D-5L) at 15 ± 2 weeks. Secondary outcomes include pain intensity, disability, depressive symptoms, catastrophizing, fear of movement, pain self-efficacy, and health-related QoL assessed by the SF-12. These outcomes, together with prognostic risk and somatic symptom burden, will also be examined as potential mediators or moderators. The intervention group undergoes a 27 ± 2-week follow-up to explore mid-term durability in a single-arm pre/post analysis. Analyses follow the intent-to-treat principle using linear mixed models, with effect sizes and confidence intervals reported; multiplicity will be considered in interpreting secondary outcomes. Blinding of participants and therapists is not feasible.
DISCUSSION: This trial will clarify the added value of a brief, fidelity-assured, face-to-face CBT-CP program in Japan, where implementation remains limited. Findings are expected to guide clinical adoption, workforce training, and dissemination, while also generating hypotheses about for whom and through which processes CBT-CP may confer benefit.
TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry, UMIN000042798. Registered on 21 December 2020, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048858 .
METHODS: This open-label, randomized, parallel-group superiority trial enrolls 60 adults aged 20-80 years with chronic pain persisting ≥ 3 months and EQ-5D-5L scores ≤ 0.80, indicating reduced QoL. Participants are randomized 1:1 to treatment as usual (TAU) plus an eight-session CBT-CP program or to a waitlist control receiving TAU only. The manualized intervention includes psycho-education, relaxation, activity pacing, and cognitive restructuring, delivered weekly face-to-face, with the goal of completing eight sessions within 14 weeks. If necessary, sessions may extend beyond the 15th week; however, the post-assessment is always conducted at 15 ± 2 weeks irrespective of intervention timing. Therapists meet prespecified eligibility criteria and receive structured training, supervision, and fidelity monitoring. The primary outcome is QoL (EQ-5D-5L) at 15 ± 2 weeks. Secondary outcomes include pain intensity, disability, depressive symptoms, catastrophizing, fear of movement, pain self-efficacy, and health-related QoL assessed by the SF-12. These outcomes, together with prognostic risk and somatic symptom burden, will also be examined as potential mediators or moderators. The intervention group undergoes a 27 ± 2-week follow-up to explore mid-term durability in a single-arm pre/post analysis. Analyses follow the intent-to-treat principle using linear mixed models, with effect sizes and confidence intervals reported; multiplicity will be considered in interpreting secondary outcomes. Blinding of participants and therapists is not feasible.
DISCUSSION: This trial will clarify the added value of a brief, fidelity-assured, face-to-face CBT-CP program in Japan, where implementation remains limited. Findings are expected to guide clinical adoption, workforce training, and dissemination, while also generating hypotheses about for whom and through which processes CBT-CP may confer benefit.
TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry, UMIN000042798. Registered on 21 December 2020, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048858 .