Abstract
IMPORTANCE: Current therapeutic approaches are inaccessible to many people with chronic pain and frequently fail to address emotion dysregulation as a key factor in psychological comorbidity and pain intensity. An effective and accessible emotion regulation-focused intervention is needed. OBJECTIVES: To compare the efficacy of online dialectical behavioral therapy for chronic pain plus treatment as usual (iDBT-Pain) with only treatment as usual on emotion dysregulation in people with chronic pain. DESIGN, SETTING, AND PARTICIPANTS: This 2-arm randomized clinical trial was conducted from March 2023 to September 2024 in Australia. Participants were adults with chronic pain (lasting ≥3 months) and weekly pain intensity of 3 or higher out of 10 (10 indicating worst pain), without psychotic or personality disorders, and without dementia. Eligible participants were randomly assigned (1:1 ratio) to receive either iDBT-Pain for 9 weeks or treatment as usual only. Intention-to-treat data analyses were performed between August and September 2024. INTERVENTIONS: The iDBT-Pain group received 8 group-based 90-minute therapist-guided online sessions as well as an app and a handbook for self-learning. Content focused on DBT skills training, including pain science education. Participants in the treatment-as-usual group continued usual care, which consisted of treatment options that can be accessed in the community. MAIN OUTCOMES AND MEASURES: The primary outcome was emotion dysregulation at 9 weeks after randomization. The Difficulties in Emotion Regulation Scale (score range: 18-90, with higher scores indicating higher emotion dysregulation) was used in assessment. RESULTS: Among 89 participants (mean [SD] age, 51.5 [14.2] years; 74 females [83%]), 44 (49%) were randomly assigned to the treatment-as-usual group and 45 (51%) were randomly assigned to the iDBT-Pain group. Overall, 79 participants (89%) completed the 9-week assessment. Between-group difference in emotion dysregulation over time favored iDBT-Pain over treatment as usual at 9 weeks (-4.88; 95% CI, -9.20 to -0.55; P = .03; Cohen d = -0.46 [95% CI, -0.87 to -0.08]). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the iDBT-Pain intervention, delivered through a self-learning and therapist-guided hybrid approach, resulted in sustained improvements in emotion dysregulation in people with chronic pain. TRIAL REGISTRATION: Anzctr.org.au Identifier: ACTRN12622000113752.