Randomized controlled trial on the effect of Internet-based Cognitive Behavioral Therapy with Real-Time Therapist Support Via a Video Conference for patients with chronic pain: A study protocol

Abstract

Background: Chronic pain, which persists for at least 12 weeks, is a serious medical condition that not only causes numerous physical and mental conditions, but also affects a person's entire life. Previous studies concerning cognitive behavioral therapy for patients with chronic pain have shown low to intermediate effectiveness. This paper describes the study protocol for a randomized controlled trial (RCT) to evaluate the effectiveness of our newly developed Internet-based Cognitive Behavioral Therapy with Real-Time Therapist Support Via a Video Conference (vCBT) as an adjunct to usual care compared with only usual care for chronic pain. Methods: The RCT comprises two parallel groups (vCBT + usual care and usual care alone) of 20 participants each (n=40) who were diagnosed with chronic pain. We aim to evaluate the effectiveness of the intervention over 16 weeks. The primary outcome is pain intensity, which will be assessed by the Numerical Rating Scale (NRS) at week 16. Secondary outcomes are pain catastrophic perception and daily life impairment degree, each assessed by the Pain Catastrophizing Scale (PCS) and Pain Disability Assessment Scale (PADS). In addition, anxiety, depression, and quality of life will be assessed. All measures will be assessed at weeks 1 (baseline), 8 (middle), and 16 (post). Discussion: This study aims to demonstrate the effectiveness of Internet-based CBT with Real-Time Therapist Support Via a Video Conference for patients with chronic pain. The findings of this study will show a feasibility and safety of online CBT for chronic pain, valuable addition to the treatment options for these patients. And we expect that many therapists will be able to universally provide CBT of comparable quality in the treatment of chronic pain by using the CBT protocol which we have developed. Trial registration: UMIN000031124 ; Open public recruiting