Individualized cognitive behavioral therapy for chronic pain in Japan: study protocol for a multicenter randomized...

Area of Science:

• Pain Management
• Psychological Therapies
• Clinical Trials

Background:

• Chronic pain significantly burdens individuals and society.
• Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is effective internationally, but evidence from Japan is limited.
• Previous Japanese trials used different formats (e.g., videoconference, longer duration) with pain intensity as the primary outcome.

Purpose of the Study:

• To evaluate the effectiveness of a brief, face-to-face, individualized CBT-CP program in Japan.
• To determine if CBT-CP improves quality of life (QoL) in adults with chronic pain.
• To provide randomized evidence for CBT-CP implementation in Japan.

Main Methods:

• An open-label, randomized, parallel-group superiority trial involving 60 adults with chronic pain.
• Participants were randomized to either treatment as usual (TAU) plus an eight-session CBT-CP program or a waitlist control receiving TAU only.
• The primary outcome was QoL, measured by the EQ-5D-5L at 15±2 weeks. Secondary outcomes included pain intensity, disability, and depressive symptoms.

Main Results:

• The study is designed to clarify the added value of a brief, fidelity-assured, face-to-face CBT-CP program.
• Results are expected to guide clinical adoption and workforce training for CBT-CP in Japan.
• The trial will also explore potential mediators and moderators of treatment benefit.

Conclusions:

• This trial will provide crucial randomized evidence on the efficacy of a brief, face-to-face CBT-CP program in Japan.
• Findings are anticipated to inform clinical practice, training, and dissemination strategies for CBT-CP.
• The study aims to generate hypotheses regarding patient subgroups and mechanisms through which CBT-CP confers benefits.